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A Study of Darvadstrocel in Adults With Crohn's Disease and Complex Perianal Fistula (EMPIRE)

Primary Purpose

Crohn's Disease, Complex Perianal Fistula

Status
Active
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
Darvadstrocel
Sponsored by
Takeda
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Crohn's Disease focused on measuring Drug therapy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. In the opinion of the investigator, the participant is capable of understanding and complying with protocol requirements.
  2. The participant signs and dates a written, informed consent form (ICF) and any required privacy authorization before the initiation of any study procedures.
  3. The participant is male or female and aged 18 years or older.
  4. The participant has complex perianal fistula(s) with a maximum of 2 internal openings and a maximum of 3 external openings based on clinical assessment and a reading of a locally-performed contrast enhanced (gadolinium) pelvic MRI. Fistula(s) must have been draining for at least 6 weeks prior to baseline visit. A complex perianal fistula is defined as a fistula that meets 1 or more of the following criteria:

    1. High inter-sphincteric, high trans-sphincteric, extra-sphincteric or suprasphincteric.
    2. Presence of ≥2 external openings.
    3. Associated perianal abscess(es). Note: Abscesses that are larger than 2 cm in at least 2 dimensions on MRI must be confirmed to have been drained adequately by the surgeon during the preparation curettage in order to be eligible.
  5. The participant has already received treatment with darvadstrocel for a complex perianal fistula at least 6 months prior to baseline visit for retreatment, and their physician has planned a repeat treatment administration for the original tract (full remission not obtained or relapse of fistula draining) or for a new complex perianal fistula tract.
  6. The participant has controlled or mildly active CD (defined as patient reported outcomes measure derived from CDAI patient reported outcome score-2 [PRO-2] score <14).
  7. A male participant who is nonsterilized and sexually active with a female partner of childbearing potential agrees to use barrier method of contraception (e.g. condom with or without spermicide) from signing of informed consent and until 1 year after repeat administration.
  8. A female participant of childbearing potential who is sexually active with a nonsterilized male partner agrees to use a highly effective/effective method of contraception from signing of informed consent and until 1 year after repeat administration.

Exclusion Criteria:

  1. The participant has lack of clinical response to prior treatment with darvadstrocel, where clinical response is defined as closure of at least 50% of all treated external fistula openings that were draining at baseline despite gentle finger compression or in the case of a unique fistula, a partial closure of the fistula.
  2. The participant has a history of hypersensitivity or allergies to darvadstrocel or related compounds.
  3. The participant has a history of hypersensitivity or allergies to penicillin or aminoglycosides; Dulbecco modified eagle medium; bovine serum; local anesthetics or gadolinium.
  4. The participant is currently participating in a double-blind clinical study with darvadstrocel. Participants participating in the ongoing INSPIRE registry (Alofisel-5003) study would need to withdraw from that study in order to enroll in this study.
  5. The participant is currently receiving or has received any other investigational medicinal product (IMP) within the last 3 months or at least 5 times the respective elimination half-life time, whichever is longer, before signing the ICF.
  6. The participant has known or suspected COVID-19 by the investigator within the past 2 months (additional testing may be performed at the discretion of the investigator). Positive antibody testing for COVID without other evidence of current or recent active infection does not exclude participation.

    a) Participants who were in screening at the time that COVID 19-related factors resulted in discontinuation may also be rescreened with approval of the sponsor or designee.

  7. The participant has major alterations in any of the following laboratory tests:

    1. Serum creatinine levels >1.5 times the upper limit of normal (ULN).
    2. Total bilirubin >1.5 × ULN.
    3. Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) >3.0 × ULN.
    4. Hemoglobin <10.0 g/dL.
    5. Platelets <75.0 × 109/L.
    6. Albumin <3.0 g/dL.
  8. The participant has an increased risk for surgical procedure.
  9. The participant has a known chronically active hepatopathy of any origin, including cirrhosis and participants with persistent positive hepatitis B surface antigen and quantitative hepatitis B virus polymerase chain reaction (PCR) or positive serology for hepatitis C virus (HCV) and quantitative HCV PCR within 6 months before the baseline visit.
  10. If female, the participant is pregnant or breastfeeding, or intending to become pregnant before participating in this study, during the study, or intending to donate ova during such time period.
  11. If male, the participant intends to donate sperm during this study.
  12. The participant has a contraindication to MRI scan (e.g., due to the presence of pacemaker, hip replacement, severe claustrophobia, or renal insufficiency as defined by local clinical guidelines).
  13. The participant has a contraindication to the anesthetic procedure.
  14. The participant has severe rectal and/or anal stenosis that would make it impossible to follow the surgery procedure.
  15. The participant has severe proctitis (rectal ulcers >0.5 cm) that would make it impossible to follow the surgery procedure.
  16. The participant has any prior invasive malignancy diagnosed within the last 3 years before baseline visit. Participants with basal cell carcinoma of the skin completely resected outside the perineal region can be included.
  17. The participant has a current or recent (within 6 months before the baseline visit) history of severe, progressive, and/or uncontrolled hepatic, hematologic, gastrointestinal (other than CD), renal, endocrine, pulmonary, cardiac, neurologic, or psychiatric disease that may result in participant's increased risk from study participation and/or lack of compliance with study procedures.
  18. The participant has had major surgery of the gastrointestinal tract within 6 months before baseline or any minor surgery of the gastrointestinal tract 3 months before baseline.
  19. The participant had local major perianal surgery, and/or treatment with darvadstrocel within 6 months before baseline. The abscess drainage, cleaning surgery, or seton placement are not considered as "local major surgery" in this protocol.
  20. The participant does not wish to or cannot comply with study procedures.

Sites / Locations

  • Akh Wien
  • NH Hospital a.s.
  • ISCARE a.s.
  • CHU de Nice - Hopital de l'Archet II - Gastro-Enterologie, Hepatologi
  • CHRU Hopital de Pontchaillou - Maladies De L'Appareil Digesti
  • CHRU de Lille - Hopital Claude Huriez - Gastroenterologie
  • CHU Amiens Picardie
  • Centre Hospitalier Lyon Sud - Gastroenterology
  • Paris St. Joseph Hospital
  • Groupe Hospitalier Diaconesses Croix Saint Simon
  • Universitaetsklinikum Carl Gustav Carus An Der Technischen Universitaet Dresden AoR
  • Stadtisches Klinikum Luneburg
  • Charite Universitatsmedizin Berlin KoR
  • Servicegesellschaft Krankenhaus Waldfriede mbH
  • Shaare Zedek Medical Center
  • Hadassah Medical Organization, Hadassah Medical Center, Ein-Karem
  • Rabin Medical Center, Beilinson Hospital
  • Tel Aviv Sourasky Medical Center
  • Chaim sheba Medical Center
  • Hospital Universitario Son Espases
  • Hospital Universitario Nuestra Senora de la Candelaria
  • H. Donostia
  • Hospital Universitario Vall d'Hebron
  • Hospital Clinic de Barcelona
  • Hospital Universitari de Bellvitge
  • Hospital Universitario Fundacion Jimenez Diaz
  • Hospital Universitario La Paz
  • C.H.U. de Pontevedra
  • H.C.U. de Valencia
  • Hospital Universitario Y Politecnico La Fe

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Darvadstrocel

Arm Description

Participants who have previously received darvadstrocel would receive a single repeat dose of darvadstrocel 120 million cells (5 million cells/mL), by local injection into the fistula.

Outcomes

Primary Outcome Measures

Percentage of Participants with at Least 1 Treatment-Emergent Adverse Event (TEAE)
An AE is any untoward medical occurrence in a participant administered a medicinal product and which does not necessarily have to have a causal relationship with this treatment. A TEAE is defined as an AE with an onset that occurs after receiving study drug.
Percentage of Participants with at Least 1 Treatment Emergent Serious Adverse Event (TESAE)
An SAE is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.
Percentage of Participants with Special Situation Reports (SSRs)
An SSR includes pregnancy, any case in which a pregnant participant is exposed to a study product or in which a female participant or female partner of a male participant becomes pregnant following treatment with a study product. Exposure is considered either through maternal exposure or via semen following paternal exposure or infant exposure from breast milk.
Percentage of Participants with Adverse Event of Special Interest (AESI)
AESI includes immunogenicity/alloimmune reactions, hypersensitivity, transmission of infectious agents, tumorgenicity (applying to malignant tumors only), ectopic tissue formation, medication errors.

Secondary Outcome Measures

Percentage of Participants who Achieve Combined Remission of Perianal Fistula(s)
Combined remission is defined as the closure of all treated external openings that were draining at baseline, despite gentle finger compression and absence of collection(s) >2 cm (in at least 2 dimensions) of the treated perianal fistula(s) confirmed by central magnetic resonance imaging (MRI) assessment.
Percentage of Participants who Achieve Clinical Remission
Clinical remission is defined as closure of all treated external fistula openings that were draining at baseline despite gentle finger compression.
Percentage of Participants who Achieve Clinical Response
Clinical response is defined as closure of at least 50% of all treated external fistula openings that were draining at baseline despite gentle finger compression.
Percentage of Participants with Relapse From Week 24 Combined Remission
Relapse is defined as reopening of any of the treated fistula(s) external openings with active drainage as clinically assessed that were in the combined remission at Week 24 or the development of a collection >2 cm (in at least 2 dimensions) of the treated perianal fistula(s) confirmed by centrally read MRI assessment.
Time to Relapse
Time to Relapse is defined as the time in days to reopening of any of the treated fistula(s) external openings with active drainage as clinically assessed, relative to Week 24.
Percentage of Participants with New Perianal Abscess in Treated Fistula
Change From Baseline in Score of Discharge and Pain Items of Perianal Disease Activity Index (PDAI) Score
The PDAI is a scoring system to evaluate the severity of perianal lesion associated with Crohn's disease. It includes the following 5 items: (a) discharge; (b) pain; (c) restriction of sexual activity; (d) type of perianal disease; and (e) degree of induration. Each item is graded on a 5-point scale ranging from no symptoms (score of 0) to severe symptoms (score of 4) and total range of score is from 0 to 20. Higher score means more severe disease.

Full Information

First Posted
October 4, 2019
Last Updated
September 25, 2023
Sponsor
Takeda
Collaborators
Takeda Development Center Americas, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT04118088
Brief Title
A Study of Darvadstrocel in Adults With Crohn's Disease and Complex Perianal Fistula
Acronym
EMPIRE
Official Title
Postauthorization Safety Study of the Long-Term Safety and Efficacy of Repeat Administration of Darvadstrocel in Patients With Crohn's Disease and Complex Perianal Fistula
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
December 22, 2020 (Actual)
Primary Completion Date
March 31, 2026 (Anticipated)
Study Completion Date
March 31, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Takeda
Collaborators
Takeda Development Center Americas, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The main aim is to check the long term side effects of a repeat treatment of darvadstrocel and to see if that treatment improves symptoms of Crohn's disease and complex perianal fistula. Participants will attend 8 clinic visits and will receive 1 treatment of darvadstrocel at the third visit. A magnetic resonance imaging (MRI) will be performed several times during the study.
Detailed Description
The biological being tested in this study is called darvadstrocel (Alofisel). This study is examining the long-term safety and efficacy of a repeat dose of darvadstrocel in people who have Crohn's disease and complex perianal fistula. The study will enroll approximately 50 patients. Participants will be assigned to one treatment group to receive: • Darvadstrocel 120 million cells All participants would be allowed to receive one repeat dose of darvadstrocel in the whole study. This multi-center trial will be conducted worldwide. The overall time to participate in this study is approximately 3 years. Participants will make multiple visits to the clinic.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Crohn's Disease, Complex Perianal Fistula
Keywords
Drug therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Darvadstrocel
Arm Type
Experimental
Arm Description
Participants who have previously received darvadstrocel would receive a single repeat dose of darvadstrocel 120 million cells (5 million cells/mL), by local injection into the fistula.
Intervention Type
Biological
Intervention Name(s)
Darvadstrocel
Other Intervention Name(s)
Alofisel, Cx601
Intervention Description
Darvadstrocel suspension of human expanded adipose stem cells.
Primary Outcome Measure Information:
Title
Percentage of Participants with at Least 1 Treatment-Emergent Adverse Event (TEAE)
Description
An AE is any untoward medical occurrence in a participant administered a medicinal product and which does not necessarily have to have a causal relationship with this treatment. A TEAE is defined as an AE with an onset that occurs after receiving study drug.
Time Frame
From administration of repeat dose up to 156 weeks post-repeat administration
Title
Percentage of Participants with at Least 1 Treatment Emergent Serious Adverse Event (TESAE)
Description
An SAE is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.
Time Frame
From administration of repeat dose up to 156 weeks post-repeat administration
Title
Percentage of Participants with Special Situation Reports (SSRs)
Description
An SSR includes pregnancy, any case in which a pregnant participant is exposed to a study product or in which a female participant or female partner of a male participant becomes pregnant following treatment with a study product. Exposure is considered either through maternal exposure or via semen following paternal exposure or infant exposure from breast milk.
Time Frame
From administration of repeat dose up to 156 weeks post-repeat administration
Title
Percentage of Participants with Adverse Event of Special Interest (AESI)
Description
AESI includes immunogenicity/alloimmune reactions, hypersensitivity, transmission of infectious agents, tumorgenicity (applying to malignant tumors only), ectopic tissue formation, medication errors.
Time Frame
From administration of repeat dose up to 156 weeks post-repeat administration
Secondary Outcome Measure Information:
Title
Percentage of Participants who Achieve Combined Remission of Perianal Fistula(s)
Description
Combined remission is defined as the closure of all treated external openings that were draining at baseline, despite gentle finger compression and absence of collection(s) >2 cm (in at least 2 dimensions) of the treated perianal fistula(s) confirmed by central magnetic resonance imaging (MRI) assessment.
Time Frame
At Week 24 and at Week 156 post-repeat darvadstrocel administration
Title
Percentage of Participants who Achieve Clinical Remission
Description
Clinical remission is defined as closure of all treated external fistula openings that were draining at baseline despite gentle finger compression.
Time Frame
At Weeks 6, 24, 52, 104, and 156 post-repeat darvadstrocel administration
Title
Percentage of Participants who Achieve Clinical Response
Description
Clinical response is defined as closure of at least 50% of all treated external fistula openings that were draining at baseline despite gentle finger compression.
Time Frame
At Weeks 6, 24, 52, 104, and 156 post-repeat darvadstrocel administration
Title
Percentage of Participants with Relapse From Week 24 Combined Remission
Description
Relapse is defined as reopening of any of the treated fistula(s) external openings with active drainage as clinically assessed that were in the combined remission at Week 24 or the development of a collection >2 cm (in at least 2 dimensions) of the treated perianal fistula(s) confirmed by centrally read MRI assessment.
Time Frame
From Week 24 to Week 156 post-repeat darvadstrocel administration
Title
Time to Relapse
Description
Time to Relapse is defined as the time in days to reopening of any of the treated fistula(s) external openings with active drainage as clinically assessed, relative to Week 24.
Time Frame
From Week 24 to the Day of relapse post-repeat darvadstrocel administration
Title
Percentage of Participants with New Perianal Abscess in Treated Fistula
Time Frame
Up to Week 156 post-repeat darvadstrocel administration
Title
Change From Baseline in Score of Discharge and Pain Items of Perianal Disease Activity Index (PDAI) Score
Description
The PDAI is a scoring system to evaluate the severity of perianal lesion associated with Crohn's disease. It includes the following 5 items: (a) discharge; (b) pain; (c) restriction of sexual activity; (d) type of perianal disease; and (e) degree of induration. Each item is graded on a 5-point scale ranging from no symptoms (score of 0) to severe symptoms (score of 4) and total range of score is from 0 to 20. Higher score means more severe disease.
Time Frame
Baseline to Weeks 6, 24, 52, 104, and 156 post-repeat darvadstrocel administration

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: In the opinion of the investigator, the participant is capable of understanding and complying with protocol requirements. The participant signs and dates a written, informed consent form (ICF) and any required privacy authorization before the initiation of any study procedures. The participant is male or female and aged 18 years or older. The participant has complex perianal fistula(s) with a maximum of 2 internal openings and a maximum of 3 external openings based on clinical assessment and a reading of a locally-performed contrast enhanced (gadolinium) pelvic MRI. Fistula(s) must have been draining for at least 6 weeks prior to baseline visit. A complex perianal fistula is defined as a fistula that meets 1 or more of the following criteria: High inter-sphincteric, high trans-sphincteric, extra-sphincteric or suprasphincteric. Presence of ≥2 external openings. Associated perianal abscess(es). Note: Abscesses that are larger than 2 cm in at least 2 dimensions on MRI must be confirmed to have been drained adequately by the surgeon during the preparation curettage in order to be eligible. The participant has already received treatment with darvadstrocel for a complex perianal fistula at least 6 months prior to baseline visit for retreatment, and their physician has planned a repeat treatment administration for the original tract (full remission not obtained or relapse of fistula draining) or for a new complex perianal fistula tract. The participant has controlled or mildly active CD (defined as patient reported outcomes measure derived from CDAI patient reported outcome score-2 [PRO-2] score <14). A male participant who is nonsterilized and sexually active with a female partner of childbearing potential agrees to use barrier method of contraception (e.g. condom with or without spermicide) from signing of informed consent and until 1 year after repeat administration. A female participant of childbearing potential who is sexually active with a nonsterilized male partner agrees to use a highly effective/effective method of contraception from signing of informed consent and until 1 year after repeat administration. Exclusion Criteria: The participant has lack of clinical response to prior treatment with darvadstrocel, where clinical response is defined as closure of at least 50% of all treated external fistula openings that were draining at baseline despite gentle finger compression or in the case of a unique fistula, a partial closure of the fistula. The participant has a history of hypersensitivity or allergies to darvadstrocel or related compounds. The participant has a history of hypersensitivity or allergies to penicillin or aminoglycosides; Dulbecco modified eagle medium; bovine serum; local anesthetics or gadolinium. The participant is currently participating in a double-blind clinical study with darvadstrocel. Participants participating in the ongoing INSPIRE registry (Alofisel-5003) study would need to withdraw from that study in order to enroll in this study. The participant is currently receiving or has received any other investigational medicinal product (IMP) within the last 3 months or at least 5 times the respective elimination half-life time, whichever is longer, before signing the ICF. The participant has known or suspected COVID-19 by the investigator within the past 2 months (additional testing may be performed at the discretion of the investigator). Positive antibody testing for COVID without other evidence of current or recent active infection does not exclude participation. a) Participants who were in screening at the time that COVID 19-related factors resulted in discontinuation may also be rescreened with approval of the sponsor or designee. The participant has major alterations in any of the following laboratory tests: Serum creatinine levels >1.5 times the upper limit of normal (ULN). Total bilirubin >1.5 × ULN. Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) >3.0 × ULN. Hemoglobin <10.0 g/dL. Platelets <75.0 × 109/L. Albumin <3.0 g/dL. The participant has an increased risk for surgical procedure. The participant has a known chronically active hepatopathy of any origin, including cirrhosis and participants with persistent positive hepatitis B surface antigen and quantitative hepatitis B virus polymerase chain reaction (PCR) or positive serology for hepatitis C virus (HCV) and quantitative HCV PCR within 6 months before the baseline visit. If female, the participant is pregnant or breastfeeding, or intending to become pregnant before participating in this study, during the study, or intending to donate ova during such time period. If male, the participant intends to donate sperm during this study. The participant has a contraindication to MRI scan (e.g., due to the presence of pacemaker, hip replacement, severe claustrophobia, or renal insufficiency as defined by local clinical guidelines). The participant has a contraindication to the anesthetic procedure. The participant has severe rectal and/or anal stenosis that would make it impossible to follow the surgery procedure. The participant has severe proctitis (rectal ulcers >0.5 cm) that would make it impossible to follow the surgery procedure. The participant has any prior invasive malignancy diagnosed within the last 3 years before baseline visit. Participants with basal cell carcinoma of the skin completely resected outside the perineal region can be included. The participant has a current or recent (within 6 months before the baseline visit) history of severe, progressive, and/or uncontrolled hepatic, hematologic, gastrointestinal (other than CD), renal, endocrine, pulmonary, cardiac, neurologic, or psychiatric disease that may result in participant's increased risk from study participation and/or lack of compliance with study procedures. The participant has had major surgery of the gastrointestinal tract within 6 months before baseline or any minor surgery of the gastrointestinal tract 3 months before baseline. The participant had local major perianal surgery, and/or treatment with darvadstrocel within 6 months before baseline. The abscess drainage, cleaning surgery, or seton placement are not considered as "local major surgery" in this protocol. The participant does not wish to or cannot comply with study procedures.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Study Director
Organizational Affiliation
Takeda
Official's Role
Study Director
Facility Information:
Facility Name
Akh Wien
City
Wien
ZIP/Postal Code
1090
Country
Austria
Facility Name
NH Hospital a.s.
City
Horovice
State/Province
Beroun
ZIP/Postal Code
268 31
Country
Czechia
Facility Name
ISCARE a.s.
City
Prague
ZIP/Postal Code
190 00
Country
Czechia
Facility Name
CHU de Nice - Hopital de l'Archet II - Gastro-Enterologie, Hepatologi
City
Nice cedex 03
State/Province
Alpes-Maritimes
ZIP/Postal Code
6202
Country
France
Facility Name
CHRU Hopital de Pontchaillou - Maladies De L'Appareil Digesti
City
Rennes
State/Province
Ille-et-Vilaine
ZIP/Postal Code
35033
Country
France
Facility Name
CHRU de Lille - Hopital Claude Huriez - Gastroenterologie
City
Lille
State/Province
Nord
ZIP/Postal Code
59037
Country
France
Facility Name
CHU Amiens Picardie
City
AMIENS cedex 1
State/Province
Picardie
ZIP/Postal Code
80054
Country
France
Facility Name
Centre Hospitalier Lyon Sud - Gastroenterology
City
Pierre-Benite
State/Province
Rhone
ZIP/Postal Code
69495
Country
France
Facility Name
Paris St. Joseph Hospital
City
Paris
ZIP/Postal Code
75014
Country
France
Facility Name
Groupe Hospitalier Diaconesses Croix Saint Simon
City
Paris
ZIP/Postal Code
75020
Country
France
Facility Name
Universitaetsklinikum Carl Gustav Carus An Der Technischen Universitaet Dresden AoR
City
Dresden
State/Province
Sachsen
ZIP/Postal Code
1307
Country
Germany
Facility Name
Stadtisches Klinikum Luneburg
City
Luneburg
State/Province
Schleswig-Holstein,
ZIP/Postal Code
21339
Country
Germany
Facility Name
Charite Universitatsmedizin Berlin KoR
City
Berlin
ZIP/Postal Code
12200
Country
Germany
Facility Name
Servicegesellschaft Krankenhaus Waldfriede mbH
City
Berlin
ZIP/Postal Code
14163
Country
Germany
Facility Name
Shaare Zedek Medical Center
City
Jerusalem
ZIP/Postal Code
9103102
Country
Israel
Facility Name
Hadassah Medical Organization, Hadassah Medical Center, Ein-Karem
City
Jerusalem
ZIP/Postal Code
91120
Country
Israel
Facility Name
Rabin Medical Center, Beilinson Hospital
City
Petah Tikva
ZIP/Postal Code
49100
Country
Israel
Facility Name
Tel Aviv Sourasky Medical Center
City
Tel Aviv
ZIP/Postal Code
64239
Country
Israel
Facility Name
Chaim sheba Medical Center
City
Tel Hashomer
ZIP/Postal Code
5262000
Country
Israel
Facility Name
Hospital Universitario Son Espases
City
Palma de Mallorca
State/Province
Baleares
ZIP/Postal Code
07120
Country
Spain
Facility Name
Hospital Universitario Nuestra Senora de la Candelaria
City
Santa Cruz de Tenerife
State/Province
Canarias,
ZIP/Postal Code
38010
Country
Spain
Facility Name
H. Donostia
City
Donostia
State/Province
San Sebastian
ZIP/Postal Code
20014
Country
Spain
Facility Name
Hospital Universitario Vall d'Hebron
City
Barcelona
ZIP/Postal Code
8035
Country
Spain
Facility Name
Hospital Clinic de Barcelona
City
Barcelona
ZIP/Postal Code
8036
Country
Spain
Facility Name
Hospital Universitari de Bellvitge
City
Barcelona
ZIP/Postal Code
8907
Country
Spain
Facility Name
Hospital Universitario Fundacion Jimenez Diaz
City
Madrid
ZIP/Postal Code
28040
Country
Spain
Facility Name
Hospital Universitario La Paz
City
Madrid
ZIP/Postal Code
28046
Country
Spain
Facility Name
C.H.U. de Pontevedra
City
Pontevedra
ZIP/Postal Code
36071
Country
Spain
Facility Name
H.C.U. de Valencia
City
Valencia
ZIP/Postal Code
46010
Country
Spain
Facility Name
Hospital Universitario Y Politecnico La Fe
City
Valencia
ZIP/Postal Code
46026
Country
Spain

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/

Learn more about this trial

A Study of Darvadstrocel in Adults With Crohn's Disease and Complex Perianal Fistula

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