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A Study of Vedolizumab in Children and Teenagers With Moderate to Severe Crohn's Disease (CD)

Primary Purpose

Crohn's Disease (CD)

Status
Recruiting
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Vedolizumab IV
Sponsored by
Takeda
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Crohn's Disease (CD) focused on measuring Drug Therapy

Eligibility Criteria

2 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. The participants has moderately to severely active CD, unresponsive or intolerant to their current standard of care (SOC).
  2. The participants weigh ≥10 kg at the time of screening and enrollment into the study.
  3. Participants with moderately to severely active Crohn's disease (CD) diagnosed at least 1 month before screening, defined by a Pediatric Crohn's Disease Activity Index (PCDAI) >30 and an simple endoscopic score for Crohn's Disease (SES-CD) >6 (or an SES-CD ≥4 if disease is confined to terminal ileum).
  4. Participants who have failed, lost response to, or been intolerant to treatment with at least 1 of the following agents: corticosteroids, immunomodulators (eg, azathioprine (AZA), 6-mercaptopurine (6-MP), methotrexate [MTX]), and/or tumor necrosis factor (TNF)-α antagonist therapy (eg, infliximab, adalimumab). This includes participants who are dependent on corticosteroids or exclusive or partial enteral nutrition to control symptoms and who are experiencing worsening of disease in the moderate-to-severe range when attempting to wean off corticosteroids or discontinue exclusive enteral nutrition.
  5. Participants with extensive colitis or pancolitis of >8 years' duration or left-sided colitis of >12 years' duration must have documented evidence of a negative surveillance colonoscopy within 12 months before screening.
  6. Participants with vaccinations that are up-to-date based on the countrywide accepted schedule of childhood vaccines.

Exclusion Criteria:

  1. Participants who have received either (1) an investigational biologic (other than those listed in Exclusion Criterion #1) within 60 days or 5 half-lives before screening (whichever is longer); or (2) an approved biologic or biosimilar agent within 2 weeks before the first dose of study drug or at any time during the screening period.
  2. Participants with active cerebral/meningeal disease, signs/symptoms or history of progressive multifocal leukoencephalopathy (PML) or any other major neurological disorders including stroke, multiple sclerosis, brain tumor or neurodegenerative disease.
  3. The participants had a clinically significant infection (eg, pneumonia, pyelonephritis, coronavirus disease 2019 [COVID-19]) within 30 days prior to first dose of study drug.
  4. The participants has received any live vaccinations within 30 days prior to first dose.
  5. Participants who currently require surgical intervention or are anticipated to require surgical intervention for CD during this study.
  6. Participants who have had subtotal or total colectomy or have a jejunostomy, ileostomy, colostomy, ileo-anal pouch, known fixed stenosis of the intestine, short bowel syndrome, or >3 small intestine resections.
  7. Participants with a current diagnosis of indeterminate colitis.
  8. Participants with clinical features suggesting monogenic very early-onset inflammatory bowel disease.
  9. Active or latent tuberculosis (TB), as evidenced by a diagnostic TB test performed within 30 days of screening or during the screening Period that is positive, defined as:

    • Positive QuantiFERON test or 2 successive indeterminate QuantiFERON tests, OR
    • A TB skin test reaction ≥5 mm.
  10. The participants has chronic hepatitis B virus (HBV) infection or chronic hepatitis C virus (HCV) infection.
  11. The participants has any identified congenital or acquired immunodeficiency (eg, common variable immunodeficiency, human immunodeficiency virus [HIV] infection, organ transplantation).
  12. The participant has evidence of dysplasia or history of malignancy other than a successfully treated non-metastatic cutaneous squamous cell or basal cell carcinoma or localized carcinoma in situ of the cervix.
  13. Participants with positive stool studies for ova and/or parasites or stool culture at screening visit.
  14. Participants with positive Clostridium difficile stool test at screening visit.

Sites / Locations

  • Phoenix Childrens Hospital
  • Cedars Sinai Medical Center
  • Rady Childrens Hospital San Diego - PIN
  • University of California San FranciscoRecruiting
  • I.H.S Health LLCRecruiting
  • Childrens Center For Digestive HealthcareRecruiting
  • Advocate Children's Hospital Park RidgeRecruiting
  • Riley Hospital For ChildrenRecruiting
  • Johns Hopkins University
  • Boston Children's Hospital
  • MNGI Digestive Health, PARecruiting
  • Mayo Clinic - PIN
  • Goryeb Children's HospitalRecruiting
  • The Steven and Alexandra Cohen Childrens Medical Center of New York - BRANY - PPDSRecruiting
  • University of Rochester Medical Center PPDSRecruiting
  • Stony Brook University Medical CenterRecruiting
  • SUNY Upstate Medical Center
  • University Hospitals Cleveland Medical Center
  • Children's Hospital of Pittsburgh
  • Hasbro Children's Hospital
  • Texas Children's HospitalRecruiting
  • Carilion Children's Tanglewood CenterRecruiting
  • Children's Hospital at Westmead
  • Queensland Childrens HospitalRecruiting
  • Monash Health, Monash Medical Centre
  • Royal Children's Hospital Melbourne - PIN
  • UZ Antwerpen
  • Universitair Ziekenhuis Brussel - PIN
  • UZ Leuven
  • University of Alberta Hospital
  • British Columbia Children's Hospital
  • London Health Sciences Centre
  • Centre Hospitalier Universitaire Sainte-Justine
  • Beijing Children Hospital,Capital Medical University
  • Henan Children's Hospital(Zhengzhou Children's Hospital)
  • Children's Hospital of Fudan University
  • The Children's Hospital Zhejiang UniversitySchool of Medicine
  • Klinika Za Djecje Bolesti ZagrebRecruiting
  • University Hospital Center ZagrebRecruiting
  • University Hospital Centre SplitRecruiting
  • Fakultni nemocnice Kralovske Vinohrady
  • Fakultni Thomayerova Nemocnice
  • Fakultni nemocnice Ostrava
  • Attikon University General HospitalRecruiting
  • Children's Hospital "Agia Sofia"Recruiting
  • Ippokratio General Hospital of Thessaloniki
  • Ippokratio General Hospital of ThessalonikiRecruiting
  • Borsod-Abauj-Zemplen Megyei Kozponti Korhaz es Egyetemi Oktato KorhazRecruiting
  • Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai KozpontRecruiting
  • Semmelweis Egyetem
  • Schneider Childrens Medical Center of Israel Petah Tikvah PIN
  • Tel Aviv Sourasky Medical Center PPDS
  • Soroka University Medical Centre
  • Rambam Medical Center - PPDS
  • Carmel Medical Center
  • Shaare Zedek Medical Center
  • Hadassah Medical Center - PPDS
  • AOU dell'Universita degli Studi della Campania Luigi Vanvitelli
  • Azienda Ospedaliera Universitaria Federico II
  • Azienda USL di Bologna
  • Sapienza University of RomeRecruiting
  • ASST di Monza - Azienda Ospedaliera San Gerardo
  • Universita degli Studi di Padova
  • Kurume University HospitalRecruiting
  • Japanese Red Cross Kumamoto HospitalRecruiting
  • Juntendo University HospitalRecruiting
  • National Center for Child Health and DevelopmentRecruiting
  • Kyungpook National University Chilgok hospitalRecruiting
  • Gachon University Gil Medical CenterRecruiting
  • Seoul National University HospitalRecruiting
  • Samsung Medical Center - PPDSRecruiting
  • Hospital of Lithuanian University of Health Sciences Kaunas ClinicsRecruiting
  • Vilnius University Hospital Santaros KlinikosRecruiting
  • Uniwersytecki Szpital Kliniczny im. Jana Mikulicza Radeckiego we Wroclawiu
  • Instytut Centrum Zdrowia Matki Polki
  • Uniwersytecki Szpital Dzieciecy
  • WIP Warsaw IBD Point Profesor Kierkus
  • Instytut Pomnik Centrum Zdrowia DzieckaRecruiting
  • Korczowski Bartosz, Gabinet LekarskiRecruiting
  • Copernicus Podmiot Leczniczy Sp. z o.o.
  • Gornoslaskie Centrum Zdrowia Dziecka Im. Sw. Jana Pawla II Spsk Nr 6 Sum W Katowicach
  • Twoja Przychodnia SCMRecruiting
  • SPZOZ Centralny Szpital Kliniczny UM w Lodzi
  • Research Center of Children's Health
  • Russian Children's Clinical Hospital of the Ministry of Health of Russia
  • Kazan State Medical University
  • Krasnoyarsk State Medical University n.a. V.F. Voyno-Ysenetskiy
  • Privolzhsky Research Medical University
  • Medical Company Hepatolog, LLC
  • Detska fakultna nemocnica s poliklinikou Banska BystricaRecruiting
  • Narodny ustav detskych chorob
  • Hospital Sant Joan de Deu - PINRecruiting
  • Hospital de SaguntoRecruiting
  • Hospital Infantil Universitario Nino Jesus - PINRecruiting
  • Hospital Regional Universitario de Malaga - Hospital Materno InfantilRecruiting
  • Hospital Universitario Virgen del Rocio - PPDSRecruiting
  • Municipal Non-profit Enterprise of Kharkiv Regional Council Regional Childrens Clinical Hospital
  • Clinic of SI National Scientific Center of Radiological Medicine of NAMS of Ukraine
  • State Institution Institute of Pediatrics, Obstetrics and Gynecology of NAMS Ukraine
  • Kings College Hospital
  • Great Ormond Street Hospital (GOSH)
  • Noahs Ark Childrens Hospital for Wales - PPDS - PIN
  • Birmingham Children's Hospital NHS Foundation Trust
  • Barts Health NHS Trust
  • Royal Manchester Children's Hospital - PPDS

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm 8

Arm 9

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

Induction Period: 10 to 15 kg, Vedolizumab 150 mg

Induction Period: >15 to <30 kg, Vedolizumab 200 mg

Induction Period: ≥30 kg, Vedolizumab 300 mg

Maintenance Period: 10 to 15 kg Vedolizumab 150 mg

Maintenance Period: 10 to 15 kg Vedolizumab 100 mg

Maintenance Period: >15 to <30 kg, Vedolizumab 200 mg

Maintenance Period: >15 to <30 kg Vedolizumab 100 mg

Maintenance Period: ≥30 kg, Vedolizumab 300 mg

Maintenance Period: ≥30 kg: Vedolizumab 150 mg

Arm Description

Vedolizumab 150 mg, intravenous (IV) infusion, at Day 1, Weeks 2 and 6 in Induction Period. Participants with CD having Baseline weight of 10 to 15 kg will be included in this arm group.

Vedolizumab 200 mg, IV infusion, at Day 1, Weeks 2 and 6 in Induction Period. Participants with CD having Baseline weight of >15 to <30 kg will be included in this arm group.

Vedolizumab 300 mg, IV infusion, at Day 1, Weeks 2 and 6 in Induction Period. Participants with CD having Baseline weight of ≥30 kg will be included in this arm group.

Vedolizumab 150 mg, IV infusion, once every 8 weeks (Q8W) from Week 14 up to Week 46 in the Maintenance Period. Participants with Week 14 weight of 10 to 15 kg who achieved clinical response at Week 14 randomized to this high dose arm group will receive vedolizumab 150 mg.

Vedolizumab 100 mg, IV infusion, Q8W from Week 14 up to Week 46 in the Maintenance Period. Participants with Week 14 weight of 10 to 15 kg who achieved clinical response at Week 14 randomized to this low dose arm group will receive vedolizumab 100 mg.

Vedolizumab 200 mg, IV infusion, Q8W from Week 14 up to Week 46 in the Maintenance Period. Participants with Week 14 weight of >15 to <30 kg who achieved clinical response at Week 14 randomized to this high dose arm group will receive vedolizumab 200 mg.

Vedolizumab 100 mg, IV infusion, Q8W from Week 14 up to Week 46 in the Maintenance Period. Participants with Week 14 weight of >15 to <30 kg who achieved clinical response at Week 14 randomized to this low dose arm group will receive vedolizumab 100 mg.

Vedolizumab 300 mg, IV infusion, Q8W from Week 14 up to Week 46 in the Maintenance Period. Participants with Week 14 weight of ≥30 kg who achieved clinical response at Week 14 randomized to this high dose arm group will receive vedolizumab 300 mg.

Vedolizumab 150 mg, IV infusion, Q8W from Week 14 up to Week 46 in the Maintenance Period. Participants with Week 14 weight of ≥30 kg who achieved clinical response at Week 14 randomized to this low dose arm group will receive vedolizumab 150 mg.

Outcomes

Primary Outcome Measures

Percentage of Participants With Clinical Remission at Week 54 Based on Pediatric Crohn's Disease Activity Index (PCDAI) Score ≤10
Clinical remission is defined by PCDAI score ≤10. The PCDAI was specifically designed for use in children. The PCDAI includes a child-specific item: the height velocity variable as well as three laboratory parameters: hematocrit (HCT) (adjusted for age and sex), erythrocyte sedimentation rate (ESR), and albumin level. The PCDAI score ranges from 0 to 100, with higher scores indicating more active disease. A score of <10 will be consistent with inactive disease, 11 to 30 will indicate mild disease, and >30 will indicate moderate to severe disease. A decrease of 12.5 points is taken as evidence of improvement.
Percentage of Participants With Endoscopic Response at Week 54 Based on Simple Endoscopic Score for Crohn's Disease [SES-CD] Score
Endoscopic response is defined as at least a 50% reduction in SES-CD score from Baseline. The overall SES-CD score ranges from 0 to 56 and is the sum of 4 variables (ie, size of ulcers [cm], ulcerated surface, affected surface [%], and presence of narrowing) across 5 bowel segments (ie, rectum, descending and sigmoid colon, transverse colon, ascending colon, and ileum). Each variable is coded from 0 to 3 based on severity, where 0 is none or not severe and 3 is the most severe case, with the sum of the scores for each variable ranging from 0 to 15, except for presence of narrowing. Presence of narrowing ranges from 0 to 11 since a severity of 3 represents a narrowing which a colonoscope cannot be passed and, thus, can only be observed once among the bowel segments. The segmental SES-CD score is the sum of the 4 variables for each bowel segment and can range from 0 to 12, where each individual variable score ranges from 0 to 3.

Secondary Outcome Measures

Percentage of Participants with Clinical and Endoscopic Remission at Week 14 Based on Both PCDAI Score and SES-CD Score
Clinical and endoscopic remission is where participant achieves both clinical and endoscopic remission. Clinical remission is defined by PCDAI score ≤10. Endoscopic remission is defined by SES-CD score of ≤4 with at least a 2-point reduction from Baseline and no sub-score >1. PCDAI includes child-specific item: height velocity variable as well as three laboratory parameters: HCT, ESR, albumin level. PCDAI score ranges from 0 to 100, with higher scores indicating more active disease. The SES-CD score ranges from 0 to 56 and is the sum of 4 variables, size of ulcers [cm], ulcerated surface, affected surface [%], and presence of narrowing) across 5 bowel segments (ie, rectum, descending and sigmoid colon, transverse colon, ascending colon, and ileum), where higher scores indicate more severe disease.
Percentage of Participants with Clinical and Endoscopic Remission at Week 54 Based on Both PCDAI Score and SES-CD Score
Clinical and endoscopic remission is where participant achieves both clinical and endoscopic remission. Clinical remission is defined by PCDAI score ≤10. Endoscopic remission is defined by SES-CD score of ≤4 with at least a 2-point reduction from Baseline and no sub-score >1. PCDAI includes child-specific item: height velocity variable as well as three laboratory parameters: HCT, ESR, albumin level. PCDAI score ranges from 0 to 100, with higher scores indicating more active disease. The SES-CD score ranges from 0 to 56 and is the sum of 4 variables, size of ulcers [cm], ulcerated surface, affected surface [%], and presence of narrowing) across 5 bowel segments (ie, rectum, descending and sigmoid colon, transverse colon, ascending colon, and ileum), where higher scores indicate more severe disease.
Percentage of Participants with Sustained Clinical and Endoscopic Remission at Week 54
Sustained clinical and endoscopic remission is where a participant achieved clinical and endoscopic remission based on PCDAI and SES-CD scores at Weeks 14 and 54. Clinical remission is defined by PCDAI score ≤10. Endoscopic remission is defined as ≤4 with at least a 2-point reduction from Baseline and no sub-score >1 by SES-CD. The PCDAI includes a child-specific item: the height velocity variable as well as three laboratory parameters: HCT, ESR, and albumin level. The PCDAI score ranges from 0 to 100, with higher scores indicating more active disease. The SES-CD score ranges from 0 to 56 and is the sum of 4 variables, size of ulcers [cm], ulcerated surface, affected surface [%], and presence of narrowing) across 5 bowel segments (ie, rectum, descending and sigmoid colon, transverse colon, ascending colon, and ileum), where higher scores indicate more severe disease.
Percentage of Participants with Corticosteroid-free Remission at Week 54 Based on PCDAI Score
Corticosteroid-free clinical remission is where participants achieves corticosteroid-free clinical remission based on PCDAI at Week 54 and has been off corticosteroids at least 12 weeks prior to and at Week 54. Clinical remission is defined by PCDAI score ≤10. The PCDAI includes a child-specific item: the height velocity variable as well as three laboratory parameters: HCT, ESR, and albumin level. The PCDAI score ranges from 0 to 100, with higher scores indicating more active disease.
Percentage of Participants with Sustained Endoscopic Remission Based on SES-CD Score
Sustained endoscopic remission is where participants achieves endoscopic remission based on SES-CD ≤4 with at least a 2-point reduction from Baseline and no sub-score >1. The SES-CD evaluates 4 endoscopic variables (Size of ulcers, Ulcerated surface, Affected surface and Presence of narrowing). The score for each endoscopic variable is sum of values obtained for each segment. The SES-CD total is the sum of the four endoscopic variable scores from 0 to 56, where higher scores indicate more severe disease.
Percentage of Participants with Sustained Endoscopic Remission Based on SES-CD Score
Sustained endoscopic remission is where participants achieves endoscopic remission based on SES-CD ≤4 with at least a 2-point reduction from Baseline and no sub-score >1. The SES-CD evaluates 4 endoscopic variables (Size of ulcers, Ulcerated surface, Affected surface and Presence of narrowing). The score for each endoscopic variable is sum of values obtained for each segment. The SES-CD total is the sum of the four endoscopic variable scores from 0 to 56, where higher scores indicate more severe disease.
Percentage of Participants with Sustained Clinical Remission at Week 14 Based on PCDAI Score
Sustained Clinical Remission is where participants will achieve clinical remission based on PCDAI at Weeks 14 and 54. Clinical remission is defined by PCDAI score ≤10. The PCDAI includes a child-specific item: the height velocity variable as well as three laboratory parameters: HCT, ESR, and albumin level. The PCDAI score will range from 0 to 100, with higher scores indicating more active disease.
Percentage of Participants with Sustained Clinical Remission at Week 54 Based on PCDAI Score
Sustained Clinical Remission is where participants will achieve clinical remission based on PCDAI at Weeks 14 and 54. Clinical remission is defined by PCDAI score ≤10. The PCDAI includes a child-specific item: the height velocity variable as well as three laboratory parameters: HCT, ESR, and albumin level. The PCDAI score will range from 0 to 100, with higher scores indicating more active disease.
Serum Trough Concentrations of Vedolizumab Over Time
Percentage of Participants With Positive Antivedolizumab Antibodies
Percentage of Participants With Positive Neutralizing Antivedolizumab Antibody Titers
Sustained Clinical Response at Week 14 Based on PCDAI Score
Sustained clinical response is where a participant achieve clinical response based on PCDAI score ≤30 and reduction of the PCDAI by ≥15 points from Baseline. The PCDAI includes a child-specific item: the height velocity variable as well as three laboratory parameters: HCT, ESR, and albumin level. The PCDAI score will range from 0 to 100, with higher scores indicating more active disease.
Sustained Clinical Response at Week 54 Based on PCDAI Score
Sustained clinical response is where a participant achieve clinical response based on PCDAI score ≤30 and reduction of the PCDAI by ≥15 points from Baseline. The PCDAI includes a child-specific item: the height velocity variable as well as three laboratory parameters: HCT, ESR, and albumin level. The PCDAI score will range from 0 to 100, with higher scores indicating more active disease.
Percentage of Participants with Clinical Remission at Weeks 2, 6, 10, 14, 22, 30, 38, 46, and 54
Clinical remission is defined by PCDAI score < 10. The PCDAI was specifically designed for use in children. The PCDAI includes a child-specific item: the height velocity variable as well as three laboratory parameters: HCT (adjusted for age and sex), ESR, and albumin level. The PCDAI score will range from 0 to 100, with higher scores indicating more active disease.
Percentage of Participants with Change in Baseline in Clinical Response at Weeks 2, 6, 10, 14, 22, 30, 38, 46, and 54
Clinical Response is where participants achieves clinical response if PCDAI ≤30 with reduction in the PCDAI of ≥15 points from Baseline. The PCDAI includes a child-specific item: the height velocity variable as well as three laboratory parameters: HCT, ESR, and albumin level. The PCDAI score will range from 0 to 100, with higher scores indicating more active disease.
Percentage of Participants with at Least One Adverse Event (AE), Serious Adverse Event (SAE), and AE of special interest (AESI)
An AE is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have causal relationship with this treatment. AE can be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a drug whether it is considered related to drug. SAE is any untoward medical occurrence that at any dose: results in death, is life threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, leads to congenital anomaly/birth defect and/or is important medical event. An AESI (serious or non-serious) is one of scientific and medical concern specific to compound or program, for which ongoing monitoring and rapid communication by investigator. AESIs include- opportunistic infection, such as progressive multifocal leukoencephalopathy (PML), liver injury, malignancies, infusion-related reactions, hypersensitivity.
Change from Baseline in Weight
Change from in Baseline in weight will be calculated as: Weight at each study visit (up to Week 54) - Weight at Baseline.
Change from Baseline in Linear Growth Z-score
Linear growth Z-score will be calculated as: Z-score = (observed value - median value of the reference population)/ standard deviation value of reference population.
Percentage of Participants with Tanner Stage V at Week 54
Tanner Stage is used to define physical measurements of sexual development based on external primary and secondary sex characteristics. Female and male participants are evaluated for breast development and genital development respectively and both genders for pubic hair distribution based on a 5-stage scale ranging from Stage I (prepubertal/preadolescent characteristics) to Stage V (mature or adult characteristics).

Full Information

First Posted
March 1, 2021
Last Updated
March 15, 2023
Sponsor
Takeda
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1. Study Identification

Unique Protocol Identification Number
NCT04779320
Brief Title
A Study of Vedolizumab in Children and Teenagers With Moderate to Severe Crohn's Disease (CD)
Official Title
A Randomized, Double-Blind, Phase 3 Study to Evaluate the Efficacy and Safety of Vedolizumab Intravenous as Maintenance Therapy in Pediatric Subjects With Moderately to Severely Active Crohn's Disease Who Achieved Clinical Response Following Open-Label Vedolizumab Intravenous Therapy
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 30, 2022 (Actual)
Primary Completion Date
November 30, 2024 (Anticipated)
Study Completion Date
November 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Takeda

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Vedolizumab is a medicine that helps to reduce inflammation and pain in the digestive system. In this study, children and teenagers with moderate to severe Crohn's disease will be treated with vedolizumab. The main aim of the study is to check if participants achieve remission after treatment with the vedolizumab. Remission means symptoms improve or disappear and an endoscopy shows no signs of inflammation. Participants will receive 3 infusions of vedolizumab over 6 weeks. Then, those who have a clinical response will receive either a high dose or low dose of vedolizumab once every 8 weeks. They will receive the same dose every time.
Detailed Description
The drug being tested in this study is called vedolizumab. Vedolizumab is being tested to treat pediatric participants who have moderately to severely active CD. The drug is tested and approved in adults in approximately 70 countries. Participants to be enrolled must have failed response to, lost response to, or been intolerant to at least 1 of the current standard of care (SOC) induction and maintenance therapies for CD including exclusive and/or partial enteral nutrition therapy, immunomodulators (e.g., azathioprine [AZA], 6-mercaptopurine [6-MP], methotrexate [MTX]), and tumor necrosis factor-alpha (TNF-α) antagonists. The study will enroll approximately 120 patients. During the Induction Period participants will receive 3 doses of vedolizumab IV infusion at Day 1, Week 2, and Week 6 based on their weight at Baseline as: Participants 10 to 15 kg, Vedolizumab 150 mg Participants >15 to <30 kg, Vedolizumab 200 mg Participants ≥30 kg, Vedolizumab 300 mg At Week 14, participants who achieve clinical response will be randomly assigned (by chance, like flipping a coin) in a 1:1 ratio to one of the 2 double-blind dose groups (high dose and low dose), stratified by previous exposure/failure to TNF-α antagonists therapy or naive to TNF-α antagonists therapy, and by weight groups. Participants will receive vedolizumab IV infusions every 8 weeks (Q8W) up to Week 46 during the Maintenance Period as follows: Participants ≥30 kg, Vedolizumab 300 mg (High dose) or 150 mg (Low dose) Participants >15 to <30 kg, Vedolizumab 200 mg (High dose) 100 mg (Low dose) Participants 10 to 15 kg, Vedolizumab 150 mg (High dose) or 100 mg (Low dose) The dose will remain blinded to the participant and study doctor during the study (unless there is an urgent medical need). All participants will be administered vedolizumab via IV infusion. In participants who demonstrate lack of maintenance of clinical response during the Maintenance Period the dose will be escalated in a blinded fashion to the high dose in their weight group based on the weight at the time of the worsening of disease. In addition one-time rescue therapy with corticosteroids is allowed during Maintenance Period. This multi-center trial will be conducted worldwide. After the Week 54, participants may be eligible to continue receiving vedolizumab in extension study MLN0002-3029. Participants who do not maintain corticosteroid-free clinical response at week 54 will undergo an end-of-study (EOS) or ET visit, and a safety visit 18 weeks after the last dose of vedolizumab followed by 2 years of long term follow-up (up to 104 weeks), in addition these participants will then be eligible to enter study MLN0002-3029 for an observational LTFU period of 2 years after the last dose of study drug.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Crohn's Disease (CD)
Keywords
Drug Therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Induction Period: 10 to 15 kg, Vedolizumab 150 mg
Arm Type
Experimental
Arm Description
Vedolizumab 150 mg, intravenous (IV) infusion, at Day 1, Weeks 2 and 6 in Induction Period. Participants with CD having Baseline weight of 10 to 15 kg will be included in this arm group.
Arm Title
Induction Period: >15 to <30 kg, Vedolizumab 200 mg
Arm Type
Experimental
Arm Description
Vedolizumab 200 mg, IV infusion, at Day 1, Weeks 2 and 6 in Induction Period. Participants with CD having Baseline weight of >15 to <30 kg will be included in this arm group.
Arm Title
Induction Period: ≥30 kg, Vedolizumab 300 mg
Arm Type
Experimental
Arm Description
Vedolizumab 300 mg, IV infusion, at Day 1, Weeks 2 and 6 in Induction Period. Participants with CD having Baseline weight of ≥30 kg will be included in this arm group.
Arm Title
Maintenance Period: 10 to 15 kg Vedolizumab 150 mg
Arm Type
Experimental
Arm Description
Vedolizumab 150 mg, IV infusion, once every 8 weeks (Q8W) from Week 14 up to Week 46 in the Maintenance Period. Participants with Week 14 weight of 10 to 15 kg who achieved clinical response at Week 14 randomized to this high dose arm group will receive vedolizumab 150 mg.
Arm Title
Maintenance Period: 10 to 15 kg Vedolizumab 100 mg
Arm Type
Experimental
Arm Description
Vedolizumab 100 mg, IV infusion, Q8W from Week 14 up to Week 46 in the Maintenance Period. Participants with Week 14 weight of 10 to 15 kg who achieved clinical response at Week 14 randomized to this low dose arm group will receive vedolizumab 100 mg.
Arm Title
Maintenance Period: >15 to <30 kg, Vedolizumab 200 mg
Arm Type
Experimental
Arm Description
Vedolizumab 200 mg, IV infusion, Q8W from Week 14 up to Week 46 in the Maintenance Period. Participants with Week 14 weight of >15 to <30 kg who achieved clinical response at Week 14 randomized to this high dose arm group will receive vedolizumab 200 mg.
Arm Title
Maintenance Period: >15 to <30 kg Vedolizumab 100 mg
Arm Type
Experimental
Arm Description
Vedolizumab 100 mg, IV infusion, Q8W from Week 14 up to Week 46 in the Maintenance Period. Participants with Week 14 weight of >15 to <30 kg who achieved clinical response at Week 14 randomized to this low dose arm group will receive vedolizumab 100 mg.
Arm Title
Maintenance Period: ≥30 kg, Vedolizumab 300 mg
Arm Type
Experimental
Arm Description
Vedolizumab 300 mg, IV infusion, Q8W from Week 14 up to Week 46 in the Maintenance Period. Participants with Week 14 weight of ≥30 kg who achieved clinical response at Week 14 randomized to this high dose arm group will receive vedolizumab 300 mg.
Arm Title
Maintenance Period: ≥30 kg: Vedolizumab 150 mg
Arm Type
Experimental
Arm Description
Vedolizumab 150 mg, IV infusion, Q8W from Week 14 up to Week 46 in the Maintenance Period. Participants with Week 14 weight of ≥30 kg who achieved clinical response at Week 14 randomized to this low dose arm group will receive vedolizumab 150 mg.
Intervention Type
Drug
Intervention Name(s)
Vedolizumab IV
Other Intervention Name(s)
ENTYVIO, KYNTELES, MLN0002
Intervention Description
Vedolizumab IV
Primary Outcome Measure Information:
Title
Percentage of Participants With Clinical Remission at Week 54 Based on Pediatric Crohn's Disease Activity Index (PCDAI) Score ≤10
Description
Clinical remission is defined by PCDAI score ≤10. The PCDAI was specifically designed for use in children. The PCDAI includes a child-specific item: the height velocity variable as well as three laboratory parameters: hematocrit (HCT) (adjusted for age and sex), erythrocyte sedimentation rate (ESR), and albumin level. The PCDAI score ranges from 0 to 100, with higher scores indicating more active disease. A score of <10 will be consistent with inactive disease, 11 to 30 will indicate mild disease, and >30 will indicate moderate to severe disease. A decrease of 12.5 points is taken as evidence of improvement.
Time Frame
Week 54
Title
Percentage of Participants With Endoscopic Response at Week 54 Based on Simple Endoscopic Score for Crohn's Disease [SES-CD] Score
Description
Endoscopic response is defined as at least a 50% reduction in SES-CD score from Baseline. The overall SES-CD score ranges from 0 to 56 and is the sum of 4 variables (ie, size of ulcers [cm], ulcerated surface, affected surface [%], and presence of narrowing) across 5 bowel segments (ie, rectum, descending and sigmoid colon, transverse colon, ascending colon, and ileum). Each variable is coded from 0 to 3 based on severity, where 0 is none or not severe and 3 is the most severe case, with the sum of the scores for each variable ranging from 0 to 15, except for presence of narrowing. Presence of narrowing ranges from 0 to 11 since a severity of 3 represents a narrowing which a colonoscope cannot be passed and, thus, can only be observed once among the bowel segments. The segmental SES-CD score is the sum of the 4 variables for each bowel segment and can range from 0 to 12, where each individual variable score ranges from 0 to 3.
Time Frame
Week 54
Secondary Outcome Measure Information:
Title
Percentage of Participants with Clinical and Endoscopic Remission at Week 14 Based on Both PCDAI Score and SES-CD Score
Description
Clinical and endoscopic remission is where participant achieves both clinical and endoscopic remission. Clinical remission is defined by PCDAI score ≤10. Endoscopic remission is defined by SES-CD score of ≤4 with at least a 2-point reduction from Baseline and no sub-score >1. PCDAI includes child-specific item: height velocity variable as well as three laboratory parameters: HCT, ESR, albumin level. PCDAI score ranges from 0 to 100, with higher scores indicating more active disease. The SES-CD score ranges from 0 to 56 and is the sum of 4 variables, size of ulcers [cm], ulcerated surface, affected surface [%], and presence of narrowing) across 5 bowel segments (ie, rectum, descending and sigmoid colon, transverse colon, ascending colon, and ileum), where higher scores indicate more severe disease.
Time Frame
Week 14
Title
Percentage of Participants with Clinical and Endoscopic Remission at Week 54 Based on Both PCDAI Score and SES-CD Score
Description
Clinical and endoscopic remission is where participant achieves both clinical and endoscopic remission. Clinical remission is defined by PCDAI score ≤10. Endoscopic remission is defined by SES-CD score of ≤4 with at least a 2-point reduction from Baseline and no sub-score >1. PCDAI includes child-specific item: height velocity variable as well as three laboratory parameters: HCT, ESR, albumin level. PCDAI score ranges from 0 to 100, with higher scores indicating more active disease. The SES-CD score ranges from 0 to 56 and is the sum of 4 variables, size of ulcers [cm], ulcerated surface, affected surface [%], and presence of narrowing) across 5 bowel segments (ie, rectum, descending and sigmoid colon, transverse colon, ascending colon, and ileum), where higher scores indicate more severe disease.
Time Frame
Week 54
Title
Percentage of Participants with Sustained Clinical and Endoscopic Remission at Week 54
Description
Sustained clinical and endoscopic remission is where a participant achieved clinical and endoscopic remission based on PCDAI and SES-CD scores at Weeks 14 and 54. Clinical remission is defined by PCDAI score ≤10. Endoscopic remission is defined as ≤4 with at least a 2-point reduction from Baseline and no sub-score >1 by SES-CD. The PCDAI includes a child-specific item: the height velocity variable as well as three laboratory parameters: HCT, ESR, and albumin level. The PCDAI score ranges from 0 to 100, with higher scores indicating more active disease. The SES-CD score ranges from 0 to 56 and is the sum of 4 variables, size of ulcers [cm], ulcerated surface, affected surface [%], and presence of narrowing) across 5 bowel segments (ie, rectum, descending and sigmoid colon, transverse colon, ascending colon, and ileum), where higher scores indicate more severe disease.
Time Frame
Week 54
Title
Percentage of Participants with Corticosteroid-free Remission at Week 54 Based on PCDAI Score
Description
Corticosteroid-free clinical remission is where participants achieves corticosteroid-free clinical remission based on PCDAI at Week 54 and has been off corticosteroids at least 12 weeks prior to and at Week 54. Clinical remission is defined by PCDAI score ≤10. The PCDAI includes a child-specific item: the height velocity variable as well as three laboratory parameters: HCT, ESR, and albumin level. The PCDAI score ranges from 0 to 100, with higher scores indicating more active disease.
Time Frame
Week 54
Title
Percentage of Participants with Sustained Endoscopic Remission Based on SES-CD Score
Description
Sustained endoscopic remission is where participants achieves endoscopic remission based on SES-CD ≤4 with at least a 2-point reduction from Baseline and no sub-score >1. The SES-CD evaluates 4 endoscopic variables (Size of ulcers, Ulcerated surface, Affected surface and Presence of narrowing). The score for each endoscopic variable is sum of values obtained for each segment. The SES-CD total is the sum of the four endoscopic variable scores from 0 to 56, where higher scores indicate more severe disease.
Time Frame
Week 14
Title
Percentage of Participants with Sustained Endoscopic Remission Based on SES-CD Score
Description
Sustained endoscopic remission is where participants achieves endoscopic remission based on SES-CD ≤4 with at least a 2-point reduction from Baseline and no sub-score >1. The SES-CD evaluates 4 endoscopic variables (Size of ulcers, Ulcerated surface, Affected surface and Presence of narrowing). The score for each endoscopic variable is sum of values obtained for each segment. The SES-CD total is the sum of the four endoscopic variable scores from 0 to 56, where higher scores indicate more severe disease.
Time Frame
Week 54
Title
Percentage of Participants with Sustained Clinical Remission at Week 14 Based on PCDAI Score
Description
Sustained Clinical Remission is where participants will achieve clinical remission based on PCDAI at Weeks 14 and 54. Clinical remission is defined by PCDAI score ≤10. The PCDAI includes a child-specific item: the height velocity variable as well as three laboratory parameters: HCT, ESR, and albumin level. The PCDAI score will range from 0 to 100, with higher scores indicating more active disease.
Time Frame
Week 14
Title
Percentage of Participants with Sustained Clinical Remission at Week 54 Based on PCDAI Score
Description
Sustained Clinical Remission is where participants will achieve clinical remission based on PCDAI at Weeks 14 and 54. Clinical remission is defined by PCDAI score ≤10. The PCDAI includes a child-specific item: the height velocity variable as well as three laboratory parameters: HCT, ESR, and albumin level. The PCDAI score will range from 0 to 100, with higher scores indicating more active disease.
Time Frame
Week 54
Title
Serum Trough Concentrations of Vedolizumab Over Time
Time Frame
Predose and postdose at multiple time points (up to 54 weeks)
Title
Percentage of Participants With Positive Antivedolizumab Antibodies
Time Frame
Pre-dose (up to 54 weeks)
Title
Percentage of Participants With Positive Neutralizing Antivedolizumab Antibody Titers
Time Frame
Pre-dose (up to 54 weeks)
Title
Sustained Clinical Response at Week 14 Based on PCDAI Score
Description
Sustained clinical response is where a participant achieve clinical response based on PCDAI score ≤30 and reduction of the PCDAI by ≥15 points from Baseline. The PCDAI includes a child-specific item: the height velocity variable as well as three laboratory parameters: HCT, ESR, and albumin level. The PCDAI score will range from 0 to 100, with higher scores indicating more active disease.
Time Frame
Week 14
Title
Sustained Clinical Response at Week 54 Based on PCDAI Score
Description
Sustained clinical response is where a participant achieve clinical response based on PCDAI score ≤30 and reduction of the PCDAI by ≥15 points from Baseline. The PCDAI includes a child-specific item: the height velocity variable as well as three laboratory parameters: HCT, ESR, and albumin level. The PCDAI score will range from 0 to 100, with higher scores indicating more active disease.
Time Frame
Week 54
Title
Percentage of Participants with Clinical Remission at Weeks 2, 6, 10, 14, 22, 30, 38, 46, and 54
Description
Clinical remission is defined by PCDAI score < 10. The PCDAI was specifically designed for use in children. The PCDAI includes a child-specific item: the height velocity variable as well as three laboratory parameters: HCT (adjusted for age and sex), ESR, and albumin level. The PCDAI score will range from 0 to 100, with higher scores indicating more active disease.
Time Frame
Weeks 2, 6, 10, 14, 22, 30, 38, 46, and 54
Title
Percentage of Participants with Change in Baseline in Clinical Response at Weeks 2, 6, 10, 14, 22, 30, 38, 46, and 54
Description
Clinical Response is where participants achieves clinical response if PCDAI ≤30 with reduction in the PCDAI of ≥15 points from Baseline. The PCDAI includes a child-specific item: the height velocity variable as well as three laboratory parameters: HCT, ESR, and albumin level. The PCDAI score will range from 0 to 100, with higher scores indicating more active disease.
Time Frame
Baseline, weeks 2, 6, 10, 14, 22, 30, 38, 46, and 54
Title
Percentage of Participants with at Least One Adverse Event (AE), Serious Adverse Event (SAE), and AE of special interest (AESI)
Description
An AE is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have causal relationship with this treatment. AE can be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a drug whether it is considered related to drug. SAE is any untoward medical occurrence that at any dose: results in death, is life threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, leads to congenital anomaly/birth defect and/or is important medical event. An AESI (serious or non-serious) is one of scientific and medical concern specific to compound or program, for which ongoing monitoring and rapid communication by investigator. AESIs include- opportunistic infection, such as progressive multifocal leukoencephalopathy (PML), liver injury, malignancies, infusion-related reactions, hypersensitivity.
Time Frame
From first dose of study drug before each dose on dosing days through the Week 72
Title
Change from Baseline in Weight
Description
Change from in Baseline in weight will be calculated as: Weight at each study visit (up to Week 54) - Weight at Baseline.
Time Frame
Baseline up to Week 54
Title
Change from Baseline in Linear Growth Z-score
Description
Linear growth Z-score will be calculated as: Z-score = (observed value - median value of the reference population)/ standard deviation value of reference population.
Time Frame
Baseline up to Week 54
Title
Percentage of Participants with Tanner Stage V at Week 54
Description
Tanner Stage is used to define physical measurements of sexual development based on external primary and secondary sex characteristics. Female and male participants are evaluated for breast development and genital development respectively and both genders for pubic hair distribution based on a 5-stage scale ranging from Stage I (prepubertal/preadolescent characteristics) to Stage V (mature or adult characteristics).
Time Frame
Week 54

10. Eligibility

Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Main Inclusion Criteria: The participants has moderately to severely active CD, unresponsive or intolerant to their current standard of care (SOC). The participants weigh ≥10 kg at the time of screening and enrollment into the study. Participants with Crohn's disease (CD) diagnosed at least 1 month before screening. Participants with moderately to severely active CD defined by a Pediatric Crohn's Disease Activity Index (PCDAI) >30 and an simple endoscopic score for Crohn's Disease (SES-CD) >6 (or an SES-CD ≥4 if disease is confined to terminal ileum) at screening endoscopy. Participants who have failed, lost response to, or been intolerant to treatment with at least 1 of the following agents: corticosteroids, immunomodulators (eg, azathioprine (AZA), 6-mercaptopurine (6-MP), methotrexate [MTX]), and/or tumor necrosis factor (TNF)-α antagonist therapy (eg, infliximab, adalimumab). This includes participants who are dependent on corticosteroids or exclusive or partial enteral nutrition to control symptoms and who are experiencing worsening of disease in the moderate-to-severe range when attempting to wean off corticosteroids or discontinue exclusive enteral nutrition. Participants with extensive colitis or pancolitis of >8 years' duration or left-sided colitis of >12 years' duration must have documented evidence of a negative surveillance colonoscopy within 12 months before screening. Participants with vaccinations that are up-to-date based on the countrywide accepted schedule of childhood vaccines. Main Exclusion Criteria: Participants who have received either (1) an investigational biologic (other than those listed in Exclusion Criterion #1) within 60 days or 5 half-lives before screening (whichever is longer); or (2) an approved biologic or biosimilar agent within 2 weeks before the first dose of study drug or at any time during the screening period. Participants with active cerebral/meningeal disease, signs/symptoms or history of progressive multifocal leukoencephalopathy (PML) or any other major neurological disorders including stroke, multiple sclerosis, brain tumor or neurodegenerative disease. The participants had a clinically significant infection (eg, pneumonia, pyelonephritis, coronavirus disease 2019 [COVID-19]) within 30 days prior to first dose of study drug. The participants has received any live vaccinations within 30 days prior to first dose. Participants who currently require surgical intervention or are anticipated to require surgical intervention for CD during this study. Participants who have had subtotal or total colectomy or have a jejunostomy, ileostomy, colostomy, ileo-anal pouch, known fixed stenosis of the intestine, short bowel syndrome, or >3 small intestine resections. Participants with a current diagnosis of indeterminate colitis. Participants with clinical features suggesting monogenic very early-onset inflammatory bowel disease. Active or latent tuberculosis (TB), as evidenced by a diagnostic TB test performed within 30 days of screening or during the screening Period that is positive, defined as: Positive QuantiFERON test or 2 successive indeterminate QuantiFERON tests, OR A TB skin test reaction ≥5 mm. Participants with evidence of positive hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb). Hepatitis B virus (HBV) immune participants(i.e., hepatitis B surface antigen [HBsAg]-negative and hepatitis B antibody-positive) may, however, be included. Note: If a participant tests negative for HBsAg, but positive for HBcAb, the participant would be considered eligible if the absence of HBV DNA is confirmed by HBV DNA polymerase chain reaction reflex testing performed in the central laboratory. Participants with chronic hepatitis C virus (HCV) (ie, positive HCV antibody [HCVAb] and HCV RNA). Note: Participants who are HCVAb-positive without evidence of HCV RNA may be considered eligible (spontaneous viral clearance or previously treated and cured [defined as no evidence of HCV RNA at least 12 weeks before baseline]). The participants has any identified congenital or acquired immunodeficiency (eg, common variable immunodeficiency, human immunodeficiency virus [HIV] infection, organ transplantation). The participant has evidence of dysplasia or history of malignancy other than a successfully treated non-metastatic cutaneous squamous cell or basal cell carcinoma or localized carcinoma in situ of the cervix. Participants with positive stool studies for ova and/or parasites or stool culture at screening visit. Participants with positive Clostridioies difficile (C difficile) stool test at screening visit. Other inclusion/exclusion criteria may apply.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Takeda Contact
Phone
+1-877-825-3327
Email
medinfoUS@takeda.com
Facility Information:
Facility Name
Phoenix Childrens Hospital
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85016
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
602-933-0940
Email
apatel12@phoenixchildrens.com
First Name & Middle Initial & Last Name & Degree
Ashish Patel
Facility Name
Cedars Sinai Medical Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90048
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
310-423-7100
Email
shervin.rabizadeh@cshs.org
First Name & Middle Initial & Last Name & Degree
Shervin Rabizadeh
Facility Name
Rady Childrens Hospital San Diego - PIN
City
San Diego
State/Province
California
ZIP/Postal Code
92123
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
381-688-2247
Ext
+861
Email
yhuang815@163.com
First Name & Middle Initial & Last Name & Degree
Ying Huang
Facility Name
University of California San Francisco
City
San Francisco
State/Province
California
ZIP/Postal Code
94143
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
415-476-5892
Email
sofia.verstraete@ucsf.edu
First Name & Middle Initial & Last Name & Degree
Sofia Verstraete
Facility Name
I.H.S Health LLC
City
Kissimmee
State/Province
Florida
ZIP/Postal Code
34741
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
407-483-5389
Email
slateef@ihshealths.com
First Name & Middle Initial & Last Name & Degree
Syed Lateef
Facility Name
Childrens Center For Digestive Healthcare
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30342
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
252-426-6988
Ext
+97
Email
shlomico@tlvmc.gov.il
First Name & Middle Initial & Last Name & Degree
Shlomi Cohen
Facility Name
Advocate Children's Hospital Park Ridge
City
Park Ridge
State/Province
Illinois
ZIP/Postal Code
60068
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
847-723-7700
Email
Ts.Gunasekaran@aah.org
First Name & Middle Initial & Last Name & Degree
Thirumazhisai S. Gunasekaran
Facility Name
Riley Hospital For Children
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
317-274-3774
Email
mdelrosa@iupui.edu
First Name & Middle Initial & Last Name & Degree
Marian Pfefferkorn
Facility Name
Johns Hopkins University
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
141-095-5876
Ext
9
Email
moliva@jhmi.edu
First Name & Middle Initial & Last Name & Degree
Maria Oliva-Hemker
Facility Name
Boston Children's Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
617-355-2962
Email
naamah.zitomersky@childrens.harvard.edu
First Name & Middle Initial & Last Name & Degree
Naamah Zitomersky
Facility Name
MNGI Digestive Health, PA
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55413
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
612-813-7240
Email
Ramalingam.Arumugam@mngi.com
First Name & Middle Initial & Last Name & Degree
Ramalingam Arumugam
Facility Name
Mayo Clinic - PIN
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
507-266-0114
Email
stephens.michael@mayo.edu
First Name & Middle Initial & Last Name & Degree
Michael Stephens
Facility Name
Goryeb Children's Hospital
City
Morristown
State/Province
New Jersey
ZIP/Postal Code
07960
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
973-971-5676
Email
joel.rosh@atlantichealth.org
First Name & Middle Initial & Last Name & Degree
Joel Rosh
Facility Name
The Steven and Alexandra Cohen Childrens Medical Center of New York - BRANY - PPDS
City
New Hyde Park
State/Province
New York
ZIP/Postal Code
11042
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
516-472-3650
Email
jmarkowi2@nshs.edu
First Name & Middle Initial & Last Name & Degree
James Markowitz
Facility Name
University of Rochester Medical Center PPDS
City
Rochester
State/Province
New York
ZIP/Postal Code
14642
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
602-933-0940
Email
apatel12@phoenixchildrens.com
First Name & Middle Initial & Last Name & Degree
Ashish Patel
Facility Name
Stony Brook University Medical Center
City
Stony Brook
State/Province
New York
ZIP/Postal Code
11794
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
888-888-8888
Email
anupama.chawla@stonybrookmedicine.edu
First Name & Middle Initial & Last Name & Degree
Anupama Chawla
Facility Name
SUNY Upstate Medical Center
City
Syracuse
State/Province
New York
ZIP/Postal Code
13202
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
315-464-8444
Email
walip@upstate.edu
First Name & Middle Initial & Last Name & Degree
Prateek Wali
Facility Name
University Hospitals Cleveland Medical Center
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
216-844-1765
Email
jonathan.moses@uhhospitals.org
First Name & Middle Initial & Last Name & Degree
Jonathan Moses
Facility Name
Children's Hospital of Pittsburgh
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15201
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
412-692-6558
Email
whitney.sunseri@chp.edu
First Name & Middle Initial & Last Name & Degree
Whitney Sunseri
Facility Name
Hasbro Children's Hospital
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02903
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
401-444-7167
Email
Ssubedi1@lifespan.org
First Name & Middle Initial & Last Name & Degree
Shova Subedi
Facility Name
Texas Children's Hospital
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
832-824-1000
Email
faith.ihekweazu@bcm.edu
First Name & Middle Initial & Last Name & Degree
Faith Ihekweazu
Facility Name
Carilion Children's Tanglewood Center
City
Roanoke
State/Province
Virginia
ZIP/Postal Code
24018
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
540-985-9832
Email
jcolazagasti@carilionclinic.org
First Name & Middle Initial & Last Name & Degree
Juan Olazagasti
Facility Name
Children's Hospital at Westmead
City
Westmead
State/Province
New South Wales
ZIP/Postal Code
2145
Country
Australia
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
+61298453999
Email
shoma.dutt@health.nsw.gov.au
First Name & Middle Initial & Last Name & Degree
Shoma Dutt
Facility Name
Queensland Childrens Hospital
City
South Brisbane
State/Province
Queensland
ZIP/Postal Code
4101
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
+61730684502
Email
peter.lewindon@health.qld.gov.au
First Name & Middle Initial & Last Name & Degree
Peter Lewindon
Facility Name
Monash Health, Monash Medical Centre
City
Clayton
State/Province
Victoria
ZIP/Postal Code
3168
Country
Australia
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
+61395943177
Email
Gregory.moore@monash.edu
First Name & Middle Initial & Last Name & Degree
Gregory Moore
Facility Name
Royal Children's Hospital Melbourne - PIN
City
Parkville
State/Province
Victoria
ZIP/Postal Code
3052
Country
Australia
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
+0393455060
Email
george.alex@rch.org.au
First Name & Middle Initial & Last Name & Degree
George Alex
Facility Name
UZ Antwerpen
City
Edegem
State/Province
Antwerpen
ZIP/Postal Code
2650
Country
Belgium
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
+3238213810
Email
els.vandevijver@uza.be
First Name & Middle Initial & Last Name & Degree
Els Van de Vijver
Facility Name
Universitair Ziekenhuis Brussel - PIN
City
Jette
State/Province
Brussels
ZIP/Postal Code
1090
Country
Belgium
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
+32485022839
Email
elisabeth.degreef@uzbrussel.be
First Name & Middle Initial & Last Name & Degree
Elisabeth De Greef
Facility Name
UZ Leuven
City
Leuven
State/Province
Vlaams Brabant
ZIP/Postal Code
3000
Country
Belgium
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
+016343843
Email
ilse.hoffman@uzleuven.be
First Name & Middle Initial & Last Name & Degree
Ilse Hoffman
Facility Name
University of Alberta Hospital
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
AB T6G 2B7
Country
Canada
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
(780) 248-5420
Email
hien.huynh@ualberta.ca
First Name & Middle Initial & Last Name & Degree
Hien Huynh
Facility Name
British Columbia Children's Hospital
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V6H3V4
Country
Canada
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
(604) 377-1831
Email
kjacobson@cw.bc.ca
First Name & Middle Initial & Last Name & Degree
Kevan Jacobson
Facility Name
London Health Sciences Centre
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 4G5
Country
Canada
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
(519) 685-8500 x56836
Email
kevin.bax@lhsc.on.ca
First Name & Middle Initial & Last Name & Degree
Kevin Bax
Facility Name
Centre Hospitalier Universitaire Sainte-Justine
City
Montreal
State/Province
Quebec
Country
Canada
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
(514) 345-4931
Email
colette.deslandres@umontreal.ca
First Name & Middle Initial & Last Name & Degree
Colette Deslandres
Facility Name
Beijing Children Hospital,Capital Medical University
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100045
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
+8618940251108
Email
wujiedoc@163.com
First Name & Middle Initial & Last Name & Degree
Jie Wu
Facility Name
Henan Children's Hospital(Zhengzhou Children's Hospital)
City
Zhengzhou
State/Province
Henan
ZIP/Postal Code
450000
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
+8615890105818
Email
lixiaoqinys@126.com
First Name & Middle Initial & Last Name & Degree
Xiaoqin Li
Facility Name
Children's Hospital of Fudan University
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
201102
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
+8613816882247
Email
yhuang815@163.com
First Name & Middle Initial & Last Name & Degree
Ying Huang
Facility Name
The Children's Hospital Zhejiang UniversitySchool of Medicine
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310003
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
+8613858032920
Email
hzcjie@163.com
First Name & Middle Initial & Last Name & Degree
Jie Chen
Facility Name
Klinika Za Djecje Bolesti Zagreb
City
Zagreb
State/Province
Grad Zagreb
ZIP/Postal Code
10000
Country
Croatia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
+38514600291
Email
sanja.kolacek@gmail.com
First Name & Middle Initial & Last Name & Degree
Sanja Kolacek
Facility Name
University Hospital Center Zagreb
City
Zagreb
State/Province
Grad Zagreb
ZIP/Postal Code
10000
Country
Croatia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
+38598469865
Email
juricav1961@yahoo.com
First Name & Middle Initial & Last Name & Degree
Jurica Vukovic
Facility Name
University Hospital Centre Split
City
Split
ZIP/Postal Code
21000
Country
Croatia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
+38598432200
Email
ranka.despot11@gmail.com
First Name & Middle Initial & Last Name & Degree
Ranka Despot
Facility Name
Fakultni nemocnice Kralovske Vinohrady
City
Prague
State/Province
Praha, Hlavni Mesto
ZIP/Postal Code
100 34
Country
Czechia
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
+420267163731
Email
vladimir.volf@fnkv.cz
First Name & Middle Initial & Last Name & Degree
Vladimir Volf
Facility Name
Fakultni Thomayerova Nemocnice
City
Praha
State/Province
Praha, Hlavni Mesto
ZIP/Postal Code
140 00
Country
Czechia
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
+420261083798
Email
radim.vyhnanek@ftn.cz
First Name & Middle Initial & Last Name & Degree
Radim Vyhnanek
Facility Name
Fakultni nemocnice Ostrava
City
Ostrava
Country
Czechia
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
+420597371111
Email
astrida.sulakova@fno.cz
First Name & Middle Initial & Last Name & Degree
Astrida Sulakova
Facility Name
Attikon University General Hospital
City
Athens
State/Province
Attiki
ZIP/Postal Code
124 62
Country
Greece
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
+302105832228
Email
vpapaev@gmail.com
First Name & Middle Initial & Last Name & Degree
Vassiliki Papaevangelou
Facility Name
Children's Hospital "Agia Sofia"
City
Athens
Country
Greece
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
+302107467359
Email
a.papadopoulou@paidon-agiasofia.gr
First Name & Middle Initial & Last Name & Degree
Alexandra Papadopoulou
Facility Name
Ippokratio General Hospital of Thessaloniki
City
Thessaloniki
ZIP/Postal Code
564 29
Country
Greece
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
+302310992877
Email
xinias@email.com
First Name & Middle Initial & Last Name & Degree
Ioannis Xinias
Facility Name
Ippokratio General Hospital of Thessaloniki
City
Thessaloniki
ZIP/Postal Code
564 29
Country
Greece
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
+306947687799
Email
cagakidis@gmail.com
First Name & Middle Initial & Last Name & Degree
Charalampos Agakidis
Facility Name
Borsod-Abauj-Zemplen Megyei Kozponti Korhaz es Egyetemi Oktato Korhaz
City
Miskolc
State/Province
Borsod-Abauj-Zemplen
ZIP/Postal Code
3526
Country
Hungary
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
+3646515200
Email
szakos.iiigyek@bazmkorhaz.hu
First Name & Middle Initial & Last Name & Degree
Erzsebet Szakos
Facility Name
Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont
City
Szeged
State/Province
Csongrad
ZIP/Postal Code
6720
Country
Hungary
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
+36302497404
Email
office.pedia@med.u-szeged.hu
First Name & Middle Initial & Last Name & Degree
Csaba Bereczki
Facility Name
Semmelweis Egyetem
City
Budapest
ZIP/Postal Code
1083
Country
Hungary
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
+36208258186
Email
cseharon@gmail.com
First Name & Middle Initial & Last Name & Degree
Aron Cseh
Facility Name
Schneider Childrens Medical Center of Israel Petah Tikvah PIN
City
Petah Tikva
State/Province
HaMerkaz
ZIP/Postal Code
49202
Country
Israel
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
+97239253672
Email
raanan@shamirmd.com
First Name & Middle Initial & Last Name & Degree
Raanan Shamir
Facility Name
Tel Aviv Sourasky Medical Center PPDS
City
Jerusalem
State/Province
Yerushalayim
ZIP/Postal Code
90000
Country
Israel
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
+972524266988
Email
shlomico@tlvmc.gov.il
First Name & Middle Initial & Last Name & Degree
Shlomi Cohen
Facility Name
Soroka University Medical Centre
City
Beer Sheba
ZIP/Postal Code
84101
Country
Israel
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
+97286400653
Email
baruchy@clalit.org.il
First Name & Middle Initial & Last Name & Degree
Baruch Yerushalmi
Facility Name
Rambam Medical Center - PPDS
City
Haifa
ZIP/Postal Code
31096
Country
Israel
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
+97248543388
Email
r_shaoul@rambam.health.gov.il
First Name & Middle Initial & Last Name & Degree
Ron Shaoul
Facility Name
Carmel Medical Center
City
Haifa
ZIP/Postal Code
34362
Country
Israel
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
+4056303
Email
corinah@clalit.org.il
First Name & Middle Initial & Last Name & Degree
Corina Hartman
Facility Name
Shaare Zedek Medical Center
City
Jerusalem
ZIP/Postal Code
91031
Country
Israel
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
+97226666482
Email
turnerd@szmc.org.il
First Name & Middle Initial & Last Name & Degree
Dan Turner
Facility Name
Hadassah Medical Center - PPDS
City
Jerusalem
ZIP/Postal Code
91120
Country
Israel
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
+97226778637
Email
mord@hadassah.org.il
First Name & Middle Initial & Last Name & Degree
Mordechai Slae
Facility Name
AOU dell'Universita degli Studi della Campania Luigi Vanvitelli
City
Napoli
State/Province
Campania
ZIP/Postal Code
80131
Country
Italy
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
+390815665464
Email
caterina.strisciuglio@unicampania.it
First Name & Middle Initial & Last Name & Degree
Caterina Strisciuglio
Facility Name
Azienda Ospedaliera Universitaria Federico II
City
Napoli
State/Province
Campania
ZIP/Postal Code
80131
Country
Italy
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
+390817464565
Email
erasmo.miele@unina.it
First Name & Middle Initial & Last Name & Degree
Erasmo Miele
Facility Name
Azienda USL di Bologna
City
Bologna
State/Province
Emilia-Romagna
ZIP/Postal Code
40133
Country
Italy
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
+390516478437
Email
patrizia.alvisi@ausl.bologna.it
First Name & Middle Initial & Last Name & Degree
Patrizia Alvisi
Facility Name
Sapienza University of Rome
City
Roma
State/Province
Lazio
ZIP/Postal Code
161
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
+390649979387
Email
marina.aloi@gmail.com
First Name & Middle Initial & Last Name & Degree
Marina Aloi
Facility Name
ASST di Monza - Azienda Ospedaliera San Gerardo
City
Monza
State/Province
Lombardia
ZIP/Postal Code
20900
Country
Italy
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
+398888888888
Email
r.panceri@asst-monza.it
First Name & Middle Initial & Last Name & Degree
Roberto Panceri
Facility Name
Universita degli Studi di Padova
City
Padova
State/Province
Veneto
ZIP/Postal Code
35122
Country
Italy
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
+390498213517
Email
maracananzi@yahoo.com
First Name & Middle Initial & Last Name & Degree
Mara Cananzi
Facility Name
Kurume University Hospital
City
Kurume-Shi
State/Province
Hukuoka
ZIP/Postal Code
830-0011
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
+81942353311
Email
mizuochi_tatsuki@kurume-u.ac.jp
First Name & Middle Initial & Last Name & Degree
Tatsuki Mizuochi
Facility Name
Japanese Red Cross Kumamoto Hospital
City
Kumamoto-shi
State/Province
Kumamoto
ZIP/Postal Code
861-8520
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
+81963842111
Email
tturmso@yahoo.co.jp
First Name & Middle Initial & Last Name & Degree
Yugo Takaki
Facility Name
Juntendo University Hospital
City
Bunkyo-Ku
State/Province
Tokyo
ZIP/Postal Code
113-8431
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
+81338133111
Email
t-kudo@juntendo.ac.jp
First Name & Middle Initial & Last Name & Degree
Takahiro Kudo
Facility Name
National Center for Child Health and Development
City
Setagaya-Ku
State/Province
Tokyo
ZIP/Postal Code
157-8535
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
+81334160181
Email
arai-k@ncchd.go.jp
First Name & Middle Initial & Last Name & Degree
Katsuhiro Arai
Facility Name
Kyungpook National University Chilgok hospital
City
Daegu
State/Province
Daegu Gwang'yeogsi
ZIP/Postal Code
41404
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
+82532003780
Email
benkang@knu.ac.kr
First Name & Middle Initial & Last Name & Degree
Ben Kang
Facility Name
Gachon University Gil Medical Center
City
Incheon
State/Province
Incheon Gwang'yeogsi
ZIP/Postal Code
21565
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
+82324603213
Email
ryoo518@gilhospital.com
First Name & Middle Initial & Last Name & Degree
Eell Ryoo
Facility Name
Seoul National University Hospital
City
Seongnam
ZIP/Postal Code
Seoul
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Email
mjschj@snu.ac.kr
First Name & Middle Initial & Last Name & Degree
Jin Soo Moon
Facility Name
Samsung Medical Center - PPDS
City
Seoul
ZIP/Postal Code
6351
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
+82234103901
Email
smc_yhc@naver.com
First Name & Middle Initial & Last Name & Degree
Yon-Ho Choe
Facility Name
Hospital of Lithuanian University of Health Sciences Kaunas Clinics
City
Kaunas
State/Province
Kauno Apskritis
ZIP/Postal Code
LT-50161
Country
Lithuania
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
+37068646286
Email
rutadrk@gmail.com
First Name & Middle Initial & Last Name & Degree
Ruta Kucinskiene
Facility Name
Vilnius University Hospital Santaros Klinikos
City
Vilnius
State/Province
Vilniaus Apskritis
ZIP/Postal Code
8406
Country
Lithuania
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
+37060056127
Email
vaidotas.urbonas@santa.lt
First Name & Middle Initial & Last Name & Degree
Vaidotas Urbonas
Facility Name
Uniwersytecki Szpital Kliniczny im. Jana Mikulicza Radeckiego we Wroclawiu
City
Wroclaw
State/Province
Dolnoslaskie
ZIP/Postal Code
50-369
Country
Poland
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
+48604213864
Email
as.stawarski@poczta.onet.pl
First Name & Middle Initial & Last Name & Degree
Andrzej Stawarski
Facility Name
Instytut Centrum Zdrowia Matki Polki
City
Lodz
State/Province
Lodzkie
ZIP/Postal Code
93-338
Country
Poland
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
+48422711341
Email
elcia@friend.pl
First Name & Middle Initial & Last Name & Degree
Elzbieta Czkwianianc
Facility Name
Uniwersytecki Szpital Dzieciecy
City
Krakow
State/Province
Malopolskie
ZIP/Postal Code
30-663
Country
Poland
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
+48123339330
Email
kingakd@mp.pl
First Name & Middle Initial & Last Name & Degree
Kinga Kowalska-Duplaga
Facility Name
WIP Warsaw IBD Point Profesor Kierkus
City
Warszawa
State/Province
Mazowieckie
ZIP/Postal Code
00-728
Country
Poland
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
+48226580456
Email
m.meglicka@wip.waw.pl
First Name & Middle Initial & Last Name & Degree
Monika Meglicka
Facility Name
Instytut Pomnik Centrum Zdrowia Dziecka
City
Warszawa
State/Province
Mazowieckie
ZIP/Postal Code
04-736
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
+486002111648
Email
J.KIERKUS@IPCZD.PL
First Name & Middle Initial & Last Name & Degree
Jaroslaw Kierkus
Facility Name
Korczowski Bartosz, Gabinet Lekarski
City
Rzeszow
State/Province
Podkarpackie
ZIP/Postal Code
35-302
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
+48177404065
Email
korczowski@op.pl
First Name & Middle Initial & Last Name & Degree
Bartosz Korczowski
Facility Name
Copernicus Podmiot Leczniczy Sp. z o.o.
City
Gdansk
State/Province
Pomorskie
ZIP/Postal Code
80-803
Country
Poland
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
+48583022591
Email
pland@gumed.edu.pl
First Name & Middle Initial & Last Name & Degree
Piotr Landowski
Facility Name
Gornoslaskie Centrum Zdrowia Dziecka Im. Sw. Jana Pawla II Spsk Nr 6 Sum W Katowicach
City
Katowice
State/Province
Slaskie
ZIP/Postal Code
40-752
Country
Poland
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
+48322071700
Email
urszulachlebowczyk@wp.pl
First Name & Middle Initial & Last Name & Degree
Urszula Grzybowska-Chlebowczyk
Facility Name
Twoja Przychodnia SCM
City
Szczecin
State/Province
Zachodniopomorskie
ZIP/Postal Code
71-434
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
+48914332919
Email
gawdis@twojaprzychodnia.com
First Name & Middle Initial & Last Name & Degree
Beata Gawdis-Wojnarska
Facility Name
SPZOZ Centralny Szpital Kliniczny UM w Lodzi
City
Lodz
ZIP/Postal Code
91-738
Country
Poland
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
+48426177792
Email
ewa.toporowska-kowalska@umed.lodz.pl
First Name & Middle Initial & Last Name & Degree
Ewa Toporowska-Kowalska
Facility Name
Research Center of Children's Health
City
Moscow
State/Province
Moskva
ZIP/Postal Code
119296
Country
Russian Federation
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
+79104688689
Email
apotap@mail.ru
First Name & Middle Initial & Last Name & Degree
Alexander Potapov
Facility Name
Russian Children's Clinical Hospital of the Ministry of Health of Russia
City
Moscow
State/Province
Moskva
ZIP/Postal Code
119571
Country
Russian Federation
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
+79175549925
Email
tsimbalova@list.ru; gastro@nczd.ru
First Name & Middle Initial & Last Name & Degree
Ekaterina Tsimbalova
Facility Name
Kazan State Medical University
City
Kazan'
State/Province
Tatarstan, Respublika
ZIP/Postal Code
420012
Country
Russian Federation
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
+78432373037
Email
aelitakamalova@gmail.com
First Name & Middle Initial & Last Name & Degree
Aelita Kamalova
Facility Name
Krasnoyarsk State Medical University n.a. V.F. Voyno-Ysenetskiy
City
Krasnoyarsk
ZIP/Postal Code
660074
Country
Russian Federation
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
+79135353628
Email
vpanfiloff@mail.ru
First Name & Middle Initial & Last Name & Degree
Viktoria Panphilova
Facility Name
Privolzhsky Research Medical University
City
Nizhny Novgorod
ZIP/Postal Code
603005
Country
Russian Federation
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
+78314365659
Email
prof.kopeikin@gmail.com
First Name & Middle Initial & Last Name & Degree
Vladimir Kopeykin
Facility Name
Medical Company Hepatolog, LLC
City
Samara
ZIP/Postal Code
443045
Country
Russian Federation
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
+79033357481
Email
alenamalova@mail.ru
First Name & Middle Initial & Last Name & Degree
Elena Malova
Facility Name
Detska fakultna nemocnica s poliklinikou Banska Bystrica
City
Banska Bystrica
ZIP/Postal Code
974 09
Country
Slovakia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
+421484726513
Email
ivalachova@dfnbb.sk
First Name & Middle Initial & Last Name & Degree
Iveta Valachova
Facility Name
Narodny ustav detskych chorob
City
Bratislava
ZIP/Postal Code
833 40
Country
Slovakia
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
+421259371240
Email
iicierna@gmail.com
First Name & Middle Initial & Last Name & Degree
Iveta Cierna
Facility Name
Hospital Sant Joan de Deu - PIN
City
Esplugues de Llobregat
State/Province
Barcelona
ZIP/Postal Code
8950
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
+34871205705
Email
javier.martinc@sjd.es
First Name & Middle Initial & Last Name & Degree
Javier Martin de Carpi
Facility Name
Hospital de Sagunto
City
Sagunto
State/Province
Valencia
ZIP/Postal Code
46520
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
+34962659414
Email
laurasanchisartero@gmail.com
First Name & Middle Initial & Last Name & Degree
Laura Sanchis Artero
Facility Name
Hospital Infantil Universitario Nino Jesus - PIN
City
Madrid
ZIP/Postal Code
28009
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
+34915035900
Email
martavrb@gmail.com
First Name & Middle Initial & Last Name & Degree
Marta Velasco
Facility Name
Hospital Regional Universitario de Malaga - Hospital Materno Infantil
City
Malaga
ZIP/Postal Code
29011
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
+34951292143
Email
victor.navas@gmail.com
First Name & Middle Initial & Last Name & Degree
Victor Navas Lopez
Facility Name
Hospital Universitario Virgen del Rocio - PPDS
City
Sevilla
ZIP/Postal Code
41013
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
+34955012432
Email
alejandro.rodriguezmartinez@gmail.com
First Name & Middle Initial & Last Name & Degree
Alejandro Rodriguez Martinez
Facility Name
Municipal Non-profit Enterprise of Kharkiv Regional Council Regional Childrens Clinical Hospital
City
Kharkiv
State/Province
Kharkivs'ka Oblast
ZIP/Postal Code
61093
Country
Ukraine
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
+380667852356
Email
omelchenkohelen@gmail.com
First Name & Middle Initial & Last Name & Degree
Olena Omelchenko
Facility Name
Clinic of SI National Scientific Center of Radiological Medicine of NAMS of Ukraine
City
Kyiv
ZIP/Postal Code
3115
Country
Ukraine
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
+380504809129
Email
viktor.zygalo@ukr.net
First Name & Middle Initial & Last Name & Degree
Viktor Zygalo
Facility Name
State Institution Institute of Pediatrics, Obstetrics and Gynecology of NAMS Ukraine
City
Kyiv
ZIP/Postal Code
4050
Country
Ukraine
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
+380508565610
Email
valentynaberezenko@gmail.com
First Name & Middle Initial & Last Name & Degree
Valentyna Berezenko
Facility Name
Kings College Hospital
City
London
State/Province
London, City Of
ZIP/Postal Code
SE5 9RS
Country
United Kingdom
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
+442032991674
Email
babu.vadamalayan@nhs.net
First Name & Middle Initial & Last Name & Degree
Babu Vadamalayan
Facility Name
Great Ormond Street Hospital (GOSH)
City
London
State/Province
London, City Of
ZIP/Postal Code
WC1N 3AJ
Country
United Kingdom
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
+447779142231
Email
kelsey.jones@gosh.nhs.uk
First Name & Middle Initial & Last Name & Degree
Kelsey Jones
Facility Name
Noahs Ark Childrens Hospital for Wales - PPDS - PIN
City
Cardiff
State/Province
South Glamorgan
ZIP/Postal Code
CF14 4XW
Country
United Kingdom
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
+448888888888
Email
amar.wahid@wales.nhs.uk
First Name & Middle Initial & Last Name & Degree
Amar Wahid
Facility Name
Birmingham Children's Hospital NHS Foundation Trust
City
Birmingham
State/Province
West Midlands
ZIP/Postal Code
B4 6NH
Country
United Kingdom
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
+4401213338705
Email
rafeeq.muhammed@nhs.net
First Name & Middle Initial & Last Name & Degree
Rafeeq Muhammed
Facility Name
Barts Health NHS Trust
City
London
ZIP/Postal Code
E1 1BB
Country
United Kingdom
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
+448888888888
Email
marco.gasparetto@nhs.net
First Name & Middle Initial & Last Name & Degree
Marco Gasparetto
Facility Name
Royal Manchester Children's Hospital - PPDS
City
Manchester
ZIP/Postal Code
M27 4HA
Country
United Kingdom
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
+441617012371
Email
andrew.fagbemi@mft.nhs.uk
First Name & Middle Initial & Last Name & Degree
Andrew (Sunday) Fagbemi

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.
IPD Sharing Access Criteria
IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/. For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.
IPD Sharing URL
https://vivli.org/ourmember/takeda/
Links:
URL
https://clinicaltrials.takeda.com/study-detail/60423b8eeb9d7e001f5bc61f
Description
To obtain more information about this study, click this link.

Learn more about this trial

A Study of Vedolizumab in Children and Teenagers With Moderate to Severe Crohn's Disease (CD)

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