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A Study of Vedolizumab in Children and Teenagers With Moderate to Severe Ulcerative Colitis (UC)

Primary Purpose

Colitis, Ulcerative

Status

Recruiting

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

Vedolizumab

About this trial

This is an interventional treatment trial for Colitis, Ulcerative focused on measuring Drug Therapy

Eligibility Criteria

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

Inclusion Criteria:

Has moderately to severely active UC, unresponsive or intolerant to their current standard of care (SOC).
Weighs ≥10 kg at the time of screening and enrollment into the study.
Has moderately to severely active UC diagnosed at least 1 month before screening, defined by a modified Mayo score of 5 to 9 (sum of Mayo endoscopic subscore, stool frequency subscore, and rectal bleeding subscore) with a Mayo endoscopic subscore of ≥2 (with the presence of mucosal friability excluding an endoscopic subscore 1 and mandating a score of at least 2).
Has failed, lost response to, or been intolerant to treatment with at least 1 of the following agents: corticosteroids (eg, azathioprine [AZA], 6-mercaptopurine [6-MP], methotrexate [MTX]), immunomodulators, and/or tumor necrosis factor alpha (TNF-α) antagonist therapy (eg, infliximab, adalimumab). This includes participants who are dependent on corticosteroids to control symptoms and who are experiencing worsening of disease in the moderate-to-severe range when attempting to wean off corticosteroids.
Has evidence of UC extending proximal to the rectum (i.e., not limited to proctitis), at a minimum.
Has 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.

Exclusion Criteria:

Has previous exposure to approved or investigational anti-integrins including, but not limited to natalizumab, efalizumab, etrolizumab, or Abrilumab (AMG 181), or mucosal addressin cell adhesion molecule-1 (MAdCAM-1) antagonists or rituximab.
Has received an investigational biologic within 60 days or 5 half-lives before screening (whichever is longer); or an approved biologic or biosimilar agent within 2 weeks before the first dose of study drug or at any time during the screening period.
Has 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.
Has had clinically significant infection (eg, pneumonia, pyelonephritis, coronavirus disease 2019 [COVID-19]) within 30 days prior to first dose of study drug.
Has received any live vaccinations within 30 days prior to first dose of study drug.
Participants who currently require surgical intervention or are anticipated to require surgical intervention for UC during this study.
Has had subtotal or total colectomy or have a jejunostomy, ileostomy, colostomy, ileo-anal pouch, or known fixed stenosis of the intestine.
Participants with a current diagnosis of indeterminate colitis.
Participants with clinical features suggesting monogenic very early onset inflammatory bowel disease.
Participant with 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. NOTE: If participants have received Bacillus Calmette-Guérin vaccine then a QuantiFERON TB Gold test should be performed instead of the TB skin test.
Has chronic hepatitis B virus (HBV) infection* or chronic hepatitis C virus infection.
- HBV immune participants (ie, being hepatitis B surface antigen negative and hepatitis B antibody positive) may be included, however.
The participant has evidence of dysplasia or history of malignancy other than a successfully treated nonmetastatic cutaneous squamous cell or basal cell carcinoma or localized carcinoma in situ of the cervix.
Has positive stool studies for ova and/or parasites or stool culture at screening visit.
Has 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 UniversityRecruiting
Boston Children's Hospital
MNGI Digestive Health, PARecruiting
Mayo Clinic - PINRecruiting
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 CenterRecruiting
University Hospitals Cleveland Medical CenterRecruiting
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 CentreRecruiting
Royal Children's Hospital Melbourne - PINRecruiting
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 UniversityRecruiting
Henan Children's Hospital(Zhengzhou Children's Hospital)
Children's Hospital of Fudan UniversityRecruiting
The Children's Hospital Zhejiang UniversitySchool of MedicineRecruiting
Klinika Za Djecje Bolesti ZagrebRecruiting
University Hospital Center ZagrebRecruiting
University Hospital Centre SplitRecruiting
Fakultni nemocnice Kralovske VinohradyRecruiting
Fakultni Thomayerova NemocniceRecruiting
Fakultni nemocnice OstravaRecruiting
Attikon University General HospitalRecruiting
Children's Hospital "Agia Sofia"Recruiting
Ippokratio General Hospital of ThessalonikiRecruiting
Ippokratio General Hospital of ThessalonikiRecruiting
Borsod-Abauj-Zemplen Megyei Kozponti Korhaz es Egyetemi Oktato KorhazRecruiting
Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai KozpontRecruiting
Semmelweis Egyetem
Soroka University Medical CentreRecruiting
Rambam Medical Center - PPDSRecruiting
Carmel Medical CenterRecruiting
Shaare Zedek Medical CenterRecruiting
Hadassah Medical Center - PPDSRecruiting
Schneider Childrens Medical Center of Israel Petah Tikvah PINRecruiting
Tel Aviv Sourasky Medical Center PPDSRecruiting
AOU dell'Universita degli Studi della Campania Luigi Vanvitelli
Azienda Ospedaliera Universitaria Federico II
Azienda USL di Bologna
ASST di Monza - Azienda Ospedaliera San Gerardo
Azienda Ospedaliera Universita degli Studi di Padova
Sapienza University of RomeRecruiting
Kurume University HospitalRecruiting
Japanese Red Cross Kumamoto HospitalRecruiting
Juntendo University HospitalRecruiting
National Center for Child Health and DevelopmentRecruiting
Seoul National University HospitalRecruiting
Kyungpook National University Chilgok hospitalRecruiting
Gachon University Gil Medical CenterRecruiting
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 PolkiRecruiting
Instytut Centrum Zdrowia Matki PolkiRecruiting
Uniwersytecki Szpital Dzieciecy
WIP Warsaw IBD Point Profesor Kierkus
Instytut Pomnik Centrum Zdrowia DzieckaRecruiting
Copernicus Podmiot Leczniczy Sp. z o.o.Recruiting
Gornoslaskie Centrum Zdrowia Dziecka Im. Sw. Jana Pawla II Spsk Nr 6 Sum W Katowicach
Twoja Przychodnia SCMRecruiting
Copernicus Podmiot Leczniczy Sp. z o.o.Recruiting
SPZOZ Centralny Szpital Kliniczny UM w Lodzi
Korczowski Bartosz, Gabinet LekarskiRecruiting
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
Great Ormond Street Hospital (GOSH)
Noahs Ark Childrens Hospital for Wales - PPDS - PIN
Birmingham Children's Hospital NHS Foundation Trust
Kings College Hospital
Royal Manchester Children's Hospital - PPDS
Barts Health NHS Trust

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

Arm Label

Induction Period: Participants ≥30 kg, Vedolizumab 300 mg

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

Induction Period: Participants 10 to 15 kg, Vedolizumab 150 mg

Maintenance Period: Participants ≥30 kg, Vedolizumab 300 mg

Maintenance Period: Participants ≥30 kg, Vedolizumab 150 mg

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

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

Maintenance Period: Participants 10 to 15 kg, Vedolizumab 150 mg

Maintenance Period: Participants 10 to 15 kg, Vedolizumab 100 mg

Arm Description

Vedolizumab 300 mg, intravenous (IV) infusion, at Day 1, Weeks 2 and 6 in the Induction Period. Participants with UC having Baseline weight of ≥30 kg are included in this arm.

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

Vedolizumab 150 mg, IV infusion, at Day 1, Weeks 2 and 6 in the Induction Period. Participants with UC having Baseline weight of 10 to 15 kg are included in this arm.

Vedolizumab 300 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 ≥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.

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 150 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 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.

Outcomes

Primary Outcome Measures

Percentage of Participants with Clinical Remission at Week 54 Based on Modified Mayo Score

Clinical remission based on the modified Mayo score is defined as stool frequency subscore 0 to 1 and a decrease of 1 or more from Baseline; rectal bleeding subscore of 0; and, endoscopy subscore 0 to 1 (modified so that a score of 1 does not include friability). Mayo score is an instrument designed to measure disease activity of UC. Modified Mayo score consists of 3 sub-scores: stool frequency, rectal bleeding, and Mayo endoscopic subscore (findings on endoscopy). Each subscale is graded from 0 to 3 with higher scores indicating more severe disease. These scores are summed to give a total score range of 0 to 9. Here, higher score indicates more severe disease.

Secondary Outcome Measures

Percentage of Participants with Clinical Remission at Week 14 Based on Modified Mayo Score

Percentage of Participants with Sustained Clinical Remission at Week 14 Based on Modified Mayo Score

Sustained clinical remission is where a participant achieves clinical remission at Weeks 14 and 54, based on the modified Mayo score. It is defined as stool frequency subscore 0 to 1 and a decrease of 1 or more from Baseline; rectal bleeding subscore of 0; and, endoscopy subscore 0 to 1 (modified so that a score of 1 does not include friability). Mayo score is an instrument designed to measure disease activity of UC. Modified Mayo score consists of 3 sub-scores: stool frequency, rectal bleeding, and Mayo endoscopic subscore (findings on endoscopy). Each subscale is graded from 0 to 3 with higher scores indicating more severe disease. These scores are summed to give a total score range of 0 to 9. Here, higher score indicates more severe disease.

Percentage of Participants with Sustained Clinical Remission at Week 54 Based on Modified Mayo Score

Percentage of Participants with Sustained Endoscopic Remission at Week 14

Sustained endoscopic remission was defined as Mayo endoscopic score (MES) of ≤1 point. MES is a subscale of the Mayo score, an instrument designed to measure disease activity of UC. The subscale is graded from 0 to 3 based on the findings on endoscopy where 0=normal or inactive disease, 1=mild disease (erythema, decreased vascular pattern), 2=moderate disease (marked erythema, lack of vascular pattern, friability, erosions), 3=severe disease (spontaneous bleeding, ulceration). Higher scores indicate more severe disease.

Percentage of Participants with Sustained Endoscopic Remission at Week 54

Percentage of Participants with Endoscopic Response at Week 14

Endoscopic response was defined as a decrease in MES by ≥1 grade. MES is a subscale of the Mayo score, an instrument designed to measure disease activity of UC. The subscale is graded from 0 to 3 based on the findings on endoscopy where 0=normal or inactive disease, 1=mild disease (erythema, decreased vascular pattern), 2=moderate disease (marked erythema, lack of vascular pattern, friability, erosions), 3=severe disease (spontaneous bleeding, ulceration). Higher scores indicate more severe disease.

Percentage of Participants with Endoscopic Response at Week 54

Endoscopic response was defined as a decrease in MES by ≥1 point. MES is a subscale of the Mayo score, an instrument designed to measure disease activity of UC. The subscale is graded from 0 to 3 based on the findings on endoscopy where 0=normal or inactive disease, 1=mild disease (erythema, decreased vascular pattern), 2=moderate disease (marked erythema, lack of vascular pattern, friability, erosions), 3=severe disease (spontaneous bleeding, ulceration). Higher scores indicate more severe disease.

Percentage of Participants with Corticosteroid-free Clinical Remission at Week 54

Corticosteroid-free clinical remission is where a participant achieves corticosteroid-free clinical remission at Week 54, and was off corticosteroids at least 12 weeks prior to and at Week 54. Clinical remission based on the modified Mayo score is defined as stool frequency subscore 0 to 1 and a decrease of 1 or more from Baseline; rectal bleeding subscore of 0; and, endoscopy subscore 0 to 1 (modified so that a score of 1 does not include friability). Mayo score is an instrument designed to measure disease activity of UC. Modified Mayo score consists of 3 sub-scores: stool frequency, rectal bleeding, and Mayo endoscopic subscore (findings on endoscopy). Each subscale is graded from 0 to 3 with higher scores indicating more severe disease. These scores are summed to give a total score range of 0 to 9. Here, higher score indicates more severe disease.

Percentage of Participants with Clinical Remission at Week 54 Based on Complete Mayo Score

Clinical remission based on the complete Mayo score is where a participant achieved a complete Mayo score ≤2 points with no individual subscore >1 at Week 54. Mayo score is an instrument designed to measure disease activity of UC. Complete Mayo score consists of 4 sub-scores: stool frequency, rectal bleeding, Mayo endoscopic subscore (findings on endoscopy), and Physician's global assessment. Each subscale is graded from 0 to 3 with higher scores indicating more severe disease. These scores are summed to give a total score range of 0 to 12. Here, higher score indicates more severe disease.

Serum Trough Concentrations of Vedolizumab over Time

Percentage of Participants with Positive Anti-vedolizumab Antibodies (AVA)

Percentage of Participants with Positive Neutralizing AVA

Percentage of Participants with Sustained Clinical Response at Week 14 Based on Complete Mayo Score

Clinical response is where a participant has a reduction in complete Mayo score of ≥3 points and ≥30% from Baseline with an accompanying decrease in rectal bleeding subscore of ≥1 point or absolute rectal bleeding subscore of ≤1 point. Mayo score is an instrument designed to measure disease activity of UC. Complete Mayo score consists of 4 sub-scores: stool frequency, rectal bleeding, Mayo endoscopic subscore (findings on endoscopy), and Physician's global assessment. Each subscale is graded from 0 to 3 with higher scores indicating more severe disease. These scores are summed to give a total score range of 0 to 12. Here, higher score indicates more severe disease.

Percentage of Participants with Sustained Clinical Response at Week 54 Based on Complete Mayo Score

Percentage of Participants with Clinical Response up to Week 54 Based on Partial Mayo Score

Clinical response is defined as reduction of ≥2 points and ≥25% from the Baseline partial Mayo score, including a ≥1-point decrease in the Mayo stool frequency subscore and a ≥1-point reduction in the rectal bleeding subscore or absolute rectal bleeding subscore of ≤1 point. Partial Mayo score consists of 3 sub-scores: stool frequency, rectal bleeding, and Physician's global assessment. Each subscale is graded from 0 to 3 with higher scores indicating more severe disease. These scores are summed to give a total score range of 0 to 9. Higher score indicates more severe disease.

Percentage of Participants with Clinical Remission up to Week 54 Based on Partial Mayo Score

A partial Mayo score ≤2 points and no individual subscore >1 point.

Percentage of Participants with at least One Adverse Event (AE), Serious Adverse Event (SAE), and Adverse Event of Special Interest (AESI)

An AE is defined as any untoward medical occurrence in a clinical investigation participant administered a drug which does not necessarily have to have a causal relationship with the treatment. An SAE is defined as 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 a congenital anomaly/birth defect and/or is a important medical event. An AESI (serious or non-serious) is one of scientific and medical concern specific to the compound or program, for which ongoing monitoring and rapid communication by the investigator to Takeda may be appropriate. AESIs include: infusion-related reactions and hypersensitivity, serious infection, malignancy, or other (liver injury and progressive multifocal leukoencephalopathy [PML]).

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 Achieving Tanner Stage V

Percentage of participants achieving Tanner Stage V at Week 54 based on progression of pubertal changes from Baseline will be reported. Tanner Stage is used to measure pubertal development. Female (F) and male (M) participants are evaluated for breast development and genital development respectively and both genders for pubic hair development. Tanner Stage is based on progression through 5-stages.

Full Information

NCT ID

NCT04779307

First Posted

March 1, 2021

Last Updated

March 15, 2023

Sponsor

Takeda

1. Study Identification

Unique Protocol Identification Number

NCT04779307

Brief Title

A Study of Vedolizumab in Children and Teenagers With Moderate to Severe Ulcerative Colitis (UC)

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 Ulcerative Colitis 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

October 19, 2021 (Actual)

Primary Completion Date

May 30, 2024 (Anticipated)

Study Completion Date

May 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

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 ulcerative colitis will be treated with vedolizumab. The main aim of the study is to check if participants achieve remission after treatment with vedolizumab. Remission means symptoms improve or disappear and an endoscopy shows no or limited signs of disease. Participants will receive 3 infusions of vedolizumab over 6 weeks. Then, those who have a clinical response will receive 1 of 3 doses 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 UC. 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 UC including immunomodulators (eg, azathioprine [AZA], 6-mercaptopurine [6-MP], methotrexate [MTX]), and tumor necrosis factor-alpha (TNF-α) antagonists (eg, infliximab, adalimumab). 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: Participants ≥30 kg, Vedolizumab 300 mg Participants >15 to <30 kg, Vedolizumab 200 mg Participants 10 to 15 kg, Vedolizumab 150 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 weight. 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) or 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 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 or who discontinue study drug at any time during the induction or maintenance periods of this study will undergo a EOS or ET visit and safety visit 18 weeks after the last dose of vedolizumab, in addition these participants would then be eligible to enter study MLN0002-3029 for an observational long-term follow-up (LTFU) period of 2 years after the last dose of study drug in the current study.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Colitis, Ulcerative

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: Participants ≥30 kg, Vedolizumab 300 mg

Arm Type

Experimental

Arm Description

Vedolizumab 300 mg, intravenous (IV) infusion, at Day 1, Weeks 2 and 6 in the Induction Period. Participants with UC having Baseline weight of ≥30 kg are included in this arm.

Arm Title

Induction Period: Participants >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 the Induction Period. Participants with UC having Baseline weight of >15 to <30 kg are included in this arm.

Arm Title

Induction Period: Participants 10 to 15 kg, Vedolizumab 150 mg

Arm Type

Experimental

Arm Description

Vedolizumab 150 mg, IV infusion, at Day 1, Weeks 2 and 6 in the Induction Period. Participants with UC having Baseline weight of 10 to 15 kg are included in this arm.

Arm Title

Maintenance Period: Participants ≥30 kg, Vedolizumab 300 mg

Arm Type

Experimental

Arm Description

Arm Title

Maintenance Period: Participants ≥30 kg, Vedolizumab 150 mg

Arm Type

Experimental

Arm Description

Arm Title

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

Arm Type

Experimental

Arm Description

Arm Title

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

Arm Type

Experimental

Arm Description

Arm Title

Maintenance Period: Participants 10 to 15 kg, Vedolizumab 150 mg

Arm Type

Experimental

Arm Description

Arm Title

Maintenance Period: Participants 10 to 15 kg, Vedolizumab 100 mg

Arm Type

Experimental

Arm Description

Intervention Type

Drug

Intervention Name(s)

Vedolizumab

Other Intervention Name(s)

MLN0002, ENTYVIO, KYNTELES

Intervention Description

Vedolizumab IV infusion.

Primary Outcome Measure Information:

Title

Percentage of Participants with Clinical Remission at Week 54 Based on Modified Mayo Score

Description

Time Frame

Week 54

Secondary Outcome Measure Information:

Title

Percentage of Participants with Clinical Remission at Week 14 Based on Modified Mayo Score

Description

Time Frame

Week 14

Title

Percentage of Participants with Sustained Clinical Remission at Week 14 Based on Modified Mayo Score

Description

Time Frame

Week 14

Title

Percentage of Participants with Sustained Clinical Remission at Week 54 Based on Modified Mayo Score

Description

Time Frame

Week 54

Title

Percentage of Participants with Sustained Endoscopic Remission at Week 14

Description

Time Frame

Week 14

Title

Percentage of Participants with Sustained Endoscopic Remission at Week 54

Description

Time Frame

Week 54

Title

Percentage of Participants with Endoscopic Response at Week 14

Description

Time Frame

Week 14

Title

Percentage of Participants with Endoscopic Response at Week 54

Description

Time Frame

Week 54

Title

Percentage of Participants with Corticosteroid-free Clinical Remission at Week 54

Description

Time Frame

Week 54

Title

Percentage of Participants with Clinical Remission at Week 54 Based on Complete Mayo Score

Description

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 Anti-vedolizumab Antibodies (AVA)

Time Frame

Predose (up to 54 weeks)

Title

Percentage of Participants with Positive Neutralizing AVA

Time Frame

Predose (up to 54 weeks)

Title

Percentage of Participants with Sustained Clinical Response at Week 14 Based on Complete Mayo Score

Description

Time Frame

Week 14

Title

Percentage of Participants with Sustained Clinical Response at Week 54 Based on Complete Mayo Score

Description

Time Frame

Week 54

Title

Percentage of Participants with Clinical Response up to Week 54 Based on Partial Mayo Score

Description

Time Frame

Weeks 2, 6, 10, 14, 22, 30, 38, 46, and 54

Title

Percentage of Participants with Clinical Remission up to Week 54 Based on Partial Mayo Score

Description

A partial Mayo score ≤2 points and no individual subscore >1 point.

Time Frame

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 Adverse Event of Special Interest (AESI)

Description

Time Frame

Up to 158 weeks

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 Achieving Tanner Stage V

Description

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

Eligibility Criteria

Inclusion Criteria: Has moderately to severely active UC, unresponsive or intolerant to their current standard of care (SOC). Weighs ≥10 kg at the time of screening and enrollment into the study. Participants with UC diagnosed at least 1 month before screening. Participants with moderately to severely active UC based on a modified Mayo score of 5 to 9 (sum of Mayo endoscopic subscore, stool frequency subscore, and rectal bleeding subscore) with a Mayo endoscopic subscore of ≥2 (with the presence of mucosal friability excluding an endoscopic subscore of 1 and mandating a score of at least 2) at screening endoscopy. Has failed, lost response to, or been intolerant to treatment with at least 1 of the following agents: corticosteroids (eg, azathioprine [AZA], 6-mercaptopurine [6-MP], methotrexate [MTX]), immunomodulators, and/or tumor necrosis factor alpha (TNF-α) antagonist therapy (eg, infliximab, adalimumab). This includes participants who are dependent on corticosteroids to control symptoms and who are experiencing worsening of disease in the moderate-to-severe range when attempting to wean off corticosteroids. Has evidence of UC extending proximal to the rectum (i.e., not limited to proctitis), at a minimum. Has 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. Exclusion Criteria: Has previous exposure to approved or investigational anti-integrins including, but not limited to natalizumab, efalizumab, etrolizumab, or Abrilumab (AMG 181), or mucosal addressin cell adhesion molecule-1 (MAdCAM-1) antagonists or rituximab. Has received an investigational biologic within 60 days or 5 half-lives before screening (whichever is longer); or an approved biologic or biosimilar agent within 2 weeks before the first dose of study drug or at any time during the screening period. Has 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. Has had clinically significant infection (eg, pneumonia, pyelonephritis, coronavirus disease 2019 [COVID-19]) within 30 days prior to first dose of study drug. Has received any live vaccinations within 30 days prior to first dose of study drug. Participants who currently require surgical intervention or are anticipated to require surgical intervention for UC during this study. Has had subtotal or total colectomy or have a jejunostomy, ileostomy, colostomy, ileo-anal pouch, or known fixed stenosis of the intestine. Participants with a current diagnosis of indeterminate colitis. Participants with clinical features suggesting monogenic very early onset inflammatory bowel disease. Participant with 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. NOTE: If participants have received Bacillus Calmette-Guérin vaccine then a QuantiFERON TB Gold test should be performed instead of the TB skin test. Participants with evidence of positive hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb). Hepatitis B virus (HBV) immune participants (ie, 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: Subjects 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 participant has evidence of dysplasia or history of malignancy other than a successfully treated nonmetastatic cutaneous squamous cell or basal cell carcinoma or localized carcinoma in situ of the cervix. Has positive stool studies for ova and/or parasites or stool culture at screening visit. Has positive Clostridioides 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

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

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

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

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

94158

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Site Contact

Phone

415-476-5892

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

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

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

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

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

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Site Contact

Phone

141-095-5876

Ext

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

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

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

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Site Contact

Phone

507-266-0114

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

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

Lake Success

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

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

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

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

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Site Contact

Phone

315-464-8444

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

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Site Contact

Phone

216-844-1765

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

15224

Country

United States

Individual Site Status

Not yet recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Site Contact

Phone

412-692-6558

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

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

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

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

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

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

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Site Contact

Phone

+61395943177

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

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Site Contact

Phone

+0393455060

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

els.vandevijver@uza.be

First Name & Middle Initial & Last Name & Degree

Els Van de Vijver

Facility Name

Universitair Ziekenhuis Brussel - PIN

City

Brussel

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

elisabeth.degreef@uzbrussel.be

First Name & Middle Initial & Last Name & Degree

Elisabeth De Greef

Facility Name

UZ Leuven

City

Leuven

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

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

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

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

V6H 3V4

Country

Canada

Individual Site Status

Not yet recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Site Contact

Phone

(604) 377-1831

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 5W9

Country

Canada

Individual Site Status

Not yet recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Site Contact

Phone

(519) 685-8500 x56836

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

ZIP/Postal Code

H3T 1C5

Country

Canada

Individual Site Status

Not yet recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Site Contact

Phone

(514) 345-4931

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

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Site Contact

Phone

+8618940251108

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

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

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Site Contact

Phone

+8613816882247

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

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Site Contact

Phone

+8613858032920

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

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

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

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

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Site Contact

Phone

+420267163731

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

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Site Contact

Phone

+420261083798

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

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Site Contact

Phone

+420597371111

astrida.sulakova@fno.cz

First Name & Middle Initial & Last Name & Degree

Astrida Sulakova

Facility Name

Attikon University General Hospital

City

Chaidari

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

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

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

546 29

Country

Greece

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Site Contact

Phone

+302310992877

xinias@email.com

First Name & Middle Initial & Last Name & Degree

Ioannis Xinias

Facility Name

Ippokratio General Hospital of Thessaloniki

City

Thessaloniki

ZIP/Postal Code

54642

Country

Greece

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Site Contact

Phone

+306947687799

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

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

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

cseharon@gmail.com

First Name & Middle Initial & Last Name & Degree

Aron Cseh

Facility Name

Soroka University Medical Centre

City

Be'er Sheva

ZIP/Postal Code

84101

Country

Israel

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Site Contact

Phone

+97286400653

baruchy@clalit.org.il

First Name & Middle Initial & Last Name & Degree

Baruch Yerushalmi

Facility Name

Rambam Medical Center - PPDS

City

Haifa

ZIP/Postal Code

3109601

Country

Israel

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Site Contact

Phone

+97248543388

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

3436212

Country

Israel

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Site Contact

Phone

+4056303

corinah@clalit.org.il

First Name & Middle Initial & Last Name & Degree

Corina Hartman

Facility Name

Shaare Zedek Medical Center

City

Jerusalem

ZIP/Postal Code

9103102

Country

Israel

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Site Contact

Phone

+97226666482

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

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Site Contact

Phone

+972586645719

zevd@hadassah.org.il

First Name & Middle Initial & Last Name & Degree

Zev Davidovics

Facility Name

Schneider Childrens Medical Center of Israel Petah Tikvah PIN

City

Petah Tiqva

ZIP/Postal Code

4920235

Country

Israel

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Site Contact

Phone

+97239253672

raanan@shamirmd.com

First Name & Middle Initial & Last Name & Degree

Raanan Shamir

Facility Name

Tel Aviv Sourasky Medical Center PPDS

City

Tel Aviv

ZIP/Postal Code

6423906

Country

Israel

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Site Contact

Phone

+972524266988

shlomico@tlvmc.gov.il

First Name & Middle Initial & Last Name & Degree

Shlomi Cohen

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

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

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

patrizia.alvisi@ausl.bologna.it

First Name & Middle Initial & Last Name & Degree

Patrizia Alvisi

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

r.panceri@asst-monza.it

First Name & Middle Initial & Last Name & Degree

Roberto Panceri

Facility Name

Azienda Ospedaliera Universita degli Studi di Padova

City

Padova

State/Province

Veneto

ZIP/Postal Code

35128

Country

Italy

Individual Site Status

Not yet recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Site Contact

Phone

+390498213517

maracananzi@yahoo.com

First Name & Middle Initial & Last Name & Degree

Mara Cananzi

Facility Name

Sapienza University of Rome

City

Rome

ZIP/Postal Code

161

Country

Italy

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Site Contact

Phone

+390649979387

marina.aloi@gmail.com

First Name & Middle Initial & Last Name & Degree

Marina Aloi

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

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

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

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

arai-k@ncchd.go.jp

First Name & Middle Initial & Last Name & Degree

Katsuhiro Arai

Facility Name

Seoul National University Hospital

City

Seoul

State/Province

Seoul Teugbyeolsi

ZIP/Postal Code

3080

Country

Korea, Republic of

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Site Contact

Phone

mjschj@snu.ac.kr

First Name & Middle Initial & Last Name & Degree

Jin Soo Moon

Facility Name

Kyungpook National University Chilgok hospital

City

Daegu

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

benkang@knu.ac.kr

First Name & Middle Initial & Last Name & Degree

Ben Kang

Facility Name

Gachon University Gil Medical Center

City

Incheon

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

ryoo518@gilhospital.com

First Name & Middle Initial & Last Name & Degree

Eell Ryoo

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

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

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

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

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

93-316

Country

Poland

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Site Contact

Phone

+48422711341

elcia@friend.pl

First Name & Middle Initial & Last Name & Degree

Elzbieta Czkwianianc

Facility Name

Instytut Centrum Zdrowia Matki Polki

City

Lodz

State/Province

Lodzkie

ZIP/Postal Code

93-338

Country

Poland

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Site Contact

Phone

+48422711341

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

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

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

J.KIERKUS@IPCZD.PL

First Name & Middle Initial & Last Name & Degree

Jaroslaw Kierkus

Facility Name

Copernicus Podmiot Leczniczy Sp. z o.o.

City

Gdansk

State/Province

Pomorskie

ZIP/Postal Code

80-803

Country

Poland

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Site Contact

Phone

+48583022591

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

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

gawdis@twojaprzychodnia.com

First Name & Middle Initial & Last Name & Degree

Beata Gawdis-Wojnarska

Facility Name

Copernicus Podmiot Leczniczy Sp. z o.o.

City

Gdansk

ZIP/Postal Code

80-803

Country

Poland

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Site Contact

Phone

+48583022591

pland@gumed.edu.pl

First Name & Middle Initial & Last Name & Degree

Piotr Landowski

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

ewa.toporowska-kowalska@umed.lodz.pl

First Name & Middle Initial & Last Name & Degree

Ewa Toporowska-Kowalska

Facility Name

Korczowski Bartosz, Gabinet Lekarski

City

Rzeszow

ZIP/Postal Code

35-302

Country

Poland

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Site Contact

Phone

+48177404065

korczowski@op.pl

First Name & Middle Initial & Last Name & Degree

Bartosz Korczowski

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

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

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

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

Completed

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

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

iicierna@gmail.com

First Name & Middle Initial & Last Name & Degree

Iveta Cierna

Facility Name

Hospital Sant Joan de Deu - PIN

City

Espluges Del 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

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

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

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

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

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

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

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

valentynaberezenko@gmail.com

First Name & Middle Initial & Last Name & Degree

Valentyna Berezenko

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

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

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

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

rafeeq.muhammed@nhs.net

First Name & Middle Initial & Last Name & Degree

Rafeeq Muhammed

Facility Name

Kings College Hospital

City

London

Country

United Kingdom

Individual Site Status

Not yet recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Site Contact

Phone

+442032991674

babu.vadamalayan@nhs.net

First Name & Middle Initial & Last Name & Degree

Babu Vadamalayan

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

andrew.fagbemi@mft.nhs.uk

First Name & Middle Initial & Last Name & Degree

Andrew (Sunday) Fagbemi

Facility Name

Barts Health NHS Trust

City

Whitechapel

ZIP/Postal Code

E1 1FR

Country

United Kingdom

Individual Site Status

Not yet recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Site Contact

Phone

+448888888888

marco.gasparetto@nhs.net

First Name & Middle Initial & Last Name & Degree

Marco Gasparetto

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/60423c99eb9d7e001f5bc623

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 Ulcerative Colitis (UC)

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