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Long-term Follow-up Study With Darvadstrocel in the Treatment of Complex Perianal Fistula

Primary Purpose

Crohn's Disease, Complex Perianal Fistula

Status
Active
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Darvadstrocel
Sponsored by
Takeda
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other 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. Has participated in and completed the ADMIRE-CD II (NCT03279081) study (i.e., did not discontinue).

Exclusion Criteria:

1. Has been more than 3 months since the participant completed the ADMIRE-CD II study.

Sites / Locations

  • University of California San Francisco
  • Cedar-Sinai Medical Center
  • Hartford Hospital - Gastroenterology
  • Yale University School of Medicine
  • Mayo Clinic - Gastroenterology
  • University of Miami Hospital
  • USF Health South Tampa Center for Advanced Healthcare
  • Florida Hospital Tampa
  • Cleveland Clinic Florida
  • Indiana University - Colon and Rectal
  • University of Kansas Sxchool of Medicine
  • Colon and Rectal Surgery Associates
  • University of Maryland
  • Johns Hopkins Medicine - The Johns Hopkins Hospital
  • Massachussetts General Hospital
  • University of Massachusetts - colon & rectal surgery
  • Mayo Clinic College of Medicine - Division of Colon and Rectal Surgery - Division of Colon and Rectal Surgery
  • Barnes-Jewish Hospital - Gastroenterology
  • Dartmouth Hitchcock Medical Center - Cancer Center
  • Morristown Medical Center - Gastroenterology
  • North Shore University Hospital - Gastroenterology
  • Icahn School of Medicine at Mount Sinai
  • Lenox Hill Hospital
  • Cleveland Clinic
  • Penn State Hershey Medical Center - Surgery
  • University Surgical Associates-Rhode Island Hospital
  • Vanderbilt University Medical Center
  • University of Utah
  • University of Virginia
  • Virginia Mason Medical Center - Gastroenterology
  • Swedish Medical Center
  • Medical College of Wisconsin Hub for Collaborative Medicine - Gastroenterology and Hepatology
  • UZ Leuven - Campus Gasthuisberg
  • AZ Delta vzw - Maag-darm-leverziekten
  • GZA ziekenhuizen - Campus Sint-Vincentius - Gastro-enterology
  • UZ Gent - Gastroenterology
  • NH Hospital a.s.
  • FN Hradec Kralove
  • CHU de Nice
  • CHU de Clermont-Ferrand - Estaing
  • Hopital Saint Louis - Gastro-hepatoenterologie
  • CHRU Hopital De Pontchaillou
  • CHRU de Nancy -Hopital Brabois Adultes - Service d'Hepato- Gastroenterologie
  • CHRU De Lille - Hopital Claude Huriez - Hepato-Gastro-Enterologie
  • CHU Amiens-Picardie
  • Centre Hospitalier Lyon Sud
  • Paris St. Joseph Hospital
  • Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont - I. sz. Belgyogyaszati Klinika
  • Debreceni Egyetem Klinikai Kozpont
  • MH Egeszsegugyi Kozpont - Gasztroenterologiai Osztaly
  • Semmelweis Egyetem
  • Rabin Med Ctr Beilinson Hosp
  • Rambam Medical Centre
  • Chaim sheba Medical Center
  • Shaare Zedek Medical Center - Gastroenterology
  • Hadassah Medical Organization, Hadassah Medical Center, Ein-
  • Istituto Clinico Humanitas Rozzano, IRCCS - IBD Center
  • AOU Policlinico di Modena - Gastroenterologia
  • A.O. San Camillo Forlanini
  • Complesso Integrato Columbus
  • Policlinico Universitario Agostino Gemelli
  • Azienda Ospedaliero Universitaria S.Maria della Misericordia - Gastroenterologia
  • Centrum Medyczne Melita Medical
  • Wielospecjalistyczny Szpital Medicover
  • Endoskopia Sp z o.o.
  • Hospital Universitario Son Espases
  • H.U. G.Trias i Pujol
  • Corporacio Sanitaria Parc Tauli
  • Hospital Universitario de Fuenlabrada
  • Hospital Universitario Puerta de Hierro Majadahonda
  • Hospital Clinic de Barcelona
  • Hospital del Mar
  • Hospital Clinico San Carlos
  • Hospital Universitario Fundacion Jimenez Diaz
  • Hospital Universitario 12 de Octubre
  • Hospital Universitario La Paz
  • C.H.U. de Pontevedra
  • H.U.V. del Rocio

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Darvadstrocel

Arm Description

Participants who received a single dose of darvadstrocel, 120 million cells, intralesionally or darvadstrocel matching placebo previously in the ADMIRE-CD II study will be observed for efficacy and safety. No drug administration in this study.

Outcomes

Primary Outcome Measures

Number of Participants With Adverse Events (AEs)
An AE is defined as any untoward medical occurrence in a clinical investigation participant administered an investigational medicinal product; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (example, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug.
Number of Participants With Serious Adverse Events (SAEs)
An SAE is defined as an untoward medical occurrence, significant hazard, contraindication, side effect or precaution that at any dose: results in death, is life-threatening, required in-patient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or is medically significant.
Number of Participants With Specific Adverse Events of Special Interest (AESIs)
AESIs are AEs that are not solicited local or systemic AEs, they are predefined AEs that required close monitoring and prompt reporting to the sponsor. AESIs included protocol specified immunogenicity/alloimmune reactions, tumorgenicity and ectopic tissue formation.

Secondary Outcome Measures

Percentage of Participants who Achieve Clinical Remission at Weeks 104 and 156 (After IMP Administration in ADMIRE-CD II Study)
Clinical remission is defined as closure of all treated external fistula openings that were draining at baseline of ADMIRE-CD II despite gentle finger compression.
Percentage of Participants who Achieve Clinical Response at Weeks 104 and 156 (After IMP Administration in ADMIRE-CD II Study)
Clinical response is defined as closure of at least 50% of all treated external fistula openings that were draining at baseline of ADMIRE-CD II despite gentle finger compression.
Percentage of Participants With Relapse
Relapse is defined as participants who were in combined remission at Week 52 of ADMIRE-CD II and who have either reopening of any of the treated fistula(s) external openings with active drainage as clinically assessed or, the development of a perianal fluid collection >2 cm of the treated perianal fistulas confirmed by centrally read magnetic resonance imaging (MRI) assessment.
Percentage of Participants who Achieve Combined Clinical Remission at Week 156 (After IMP Administration in ADMIRE-CD II Study)
Combined remission of complex perianal fistula(s) is defined as the clinical assessment of closure of all treated external openings that were draining at baseline of ADMIRE-CD II, despite gentle finger compression, and absence of collection(s) >2 cm (in at least 2 dimensions) of the treated perianal fistula(s) confirmed by centrally read blinded MRI assessment.
Percentage of Participants With New Anal Abscess in Treated Fistula at Week 156
Change from Baseline of ADMIRE-CD II in Scores of Discharge Items of Perianal Disease Activity Index (PDAI) Score at Weeks 104 and 156
The PDAI is a scoring system to evaluate the severity of perianal CD. From the 5-item instrument, discharge will be used. Each category is graded on a 5-point Likert scale ranging from no symptoms (score of 0) to severe symptoms (score of 4); a higher score indicates more severe disease.
Change from Baseline of ADMIRE-CD II in Scores of Pain Items of Perianal Disease Activity Index (PDAI) Score at Weeks 104 and 156
The PDAI is a scoring system to evaluate the severity of perianal CD. From the 5-item instrument, pain will be used. Each category is graded on a 5-point Likert scale ranging from no symptoms (score of 0) to severe symptoms (score of 4); a higher score indicates more severe disease.

Full Information

First Posted
August 22, 2019
Last Updated
January 18, 2023
Sponsor
Takeda
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1. Study Identification

Unique Protocol Identification Number
NCT04075825
Brief Title
Long-term Follow-up Study With Darvadstrocel in the Treatment of Complex Perianal Fistula
Official Title
A Follow-up of a Phase 3 Study to Evaluate the Long-term Safety and Efficacy of Darvadstrocel in the Treatment of Complex Perianal Fistula in Subjects With Crohn's Disease Who Have Participated in ADMIRE II Study
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
November 4, 2019 (Actual)
Primary Completion Date
March 28, 2024 (Anticipated)
Study Completion Date
March 28, 2024 (Anticipated)

3. Sponsor/Collaborators

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

4. Oversight

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

5. Study Description

Brief Summary
The main aim is to follow-up on long term side effect and symptom improvement of Darvadstrocel in the treatment of complex perianal fistula in adults. Participants will not receive any drug in this study.
Detailed Description
The drug being tested in this study is called darvadstrocel (Cx601). Darvadstrocel is being tested to treat people who have complex perianal fistula in CD. This study will look at the long-term safety and efficacy of darvadstrocel in the treatment of complex perianal fistula in CD. The study will enroll approximately 150 patients. Participants who received darvadstrocel or placebo in study ADMIRE-CD II (Cx601-0303, NCT03279081) and who have completed the 52 weeks of the study will be enrolled in this long-term extension study. This multi-center study will be conducted worldwide. The overall time to participate in this study is 104 weeks (in addition to the 52 weeks on ADMIRE-CD II study). Participants will make multiple visits to the clinic and will be contacted by telephone every 3 months for a follow-up assessment. After unblinding of the ADMIRE-CD II study, the LTE study will be conducted as an open-label study. Participants will remain in the treatment group assigned in the ADMIRE-CD II study.

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
Other
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
151 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Darvadstrocel
Arm Type
Experimental
Arm Description
Participants who received a single dose of darvadstrocel, 120 million cells, intralesionally or darvadstrocel matching placebo previously in the ADMIRE-CD II study will be observed for efficacy and safety. No drug administration in this study.
Intervention Type
Biological
Intervention Name(s)
Darvadstrocel
Other Intervention Name(s)
Cx601
Intervention Description
Allogenic expanded adipose-derived stem cells (eASCs) 5 million cells/ml - suspension for injection darvadstrocel received in previous ADMIRE-CD II study. No drug administration in this study.
Primary Outcome Measure Information:
Title
Number of Participants With Adverse Events (AEs)
Description
An AE is defined as any untoward medical occurrence in a clinical investigation participant administered an investigational medicinal product; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (example, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug.
Time Frame
Baseline (Week 52 of ADMIRE-CD II) up to Week 156 after investigational medicinal product (IMP) administration
Title
Number of Participants With Serious Adverse Events (SAEs)
Description
An SAE is defined as an untoward medical occurrence, significant hazard, contraindication, side effect or precaution that at any dose: results in death, is life-threatening, required in-patient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or is medically significant.
Time Frame
Baseline (Week 52 of ADMIRE-CD II) up to Week 156 after IMP administration
Title
Number of Participants With Specific Adverse Events of Special Interest (AESIs)
Description
AESIs are AEs that are not solicited local or systemic AEs, they are predefined AEs that required close monitoring and prompt reporting to the sponsor. AESIs included protocol specified immunogenicity/alloimmune reactions, tumorgenicity and ectopic tissue formation.
Time Frame
Baseline (Week 52 of ADMIRE-CD II) up to Week 156 after IMP administration
Secondary Outcome Measure Information:
Title
Percentage of Participants who Achieve Clinical Remission at Weeks 104 and 156 (After IMP Administration in ADMIRE-CD II Study)
Description
Clinical remission is defined as closure of all treated external fistula openings that were draining at baseline of ADMIRE-CD II despite gentle finger compression.
Time Frame
Baseline of ADMIRE-CD II and Weeks 104 and 156
Title
Percentage of Participants who Achieve Clinical Response at Weeks 104 and 156 (After IMP Administration in ADMIRE-CD II Study)
Description
Clinical response is defined as closure of at least 50% of all treated external fistula openings that were draining at baseline of ADMIRE-CD II despite gentle finger compression.
Time Frame
Baseline of ADMIRE-CD II and Weeks 104 and 156
Title
Percentage of Participants With Relapse
Description
Relapse is defined as participants who were in combined remission at Week 52 of ADMIRE-CD II and who have either reopening of any of the treated fistula(s) external openings with active drainage as clinically assessed or, the development of a perianal fluid collection >2 cm of the treated perianal fistulas confirmed by centrally read magnetic resonance imaging (MRI) assessment.
Time Frame
Up to Week 156
Title
Percentage of Participants who Achieve Combined Clinical Remission at Week 156 (After IMP Administration in ADMIRE-CD II Study)
Description
Combined remission of complex perianal fistula(s) is defined as the clinical assessment of closure of all treated external openings that were draining at baseline of ADMIRE-CD II, despite gentle finger compression, and absence of collection(s) >2 cm (in at least 2 dimensions) of the treated perianal fistula(s) confirmed by centrally read blinded MRI assessment.
Time Frame
Baseline of ADMIRE-CD II and Week 156
Title
Percentage of Participants With New Anal Abscess in Treated Fistula at Week 156
Time Frame
Week 156
Title
Change from Baseline of ADMIRE-CD II in Scores of Discharge Items of Perianal Disease Activity Index (PDAI) Score at Weeks 104 and 156
Description
The PDAI is a scoring system to evaluate the severity of perianal CD. From the 5-item instrument, discharge will be used. Each category is graded on a 5-point Likert scale ranging from no symptoms (score of 0) to severe symptoms (score of 4); a higher score indicates more severe disease.
Time Frame
Weeks 104 and 156
Title
Change from Baseline of ADMIRE-CD II in Scores of Pain Items of Perianal Disease Activity Index (PDAI) Score at Weeks 104 and 156
Description
The PDAI is a scoring system to evaluate the severity of perianal CD. From the 5-item instrument, pain will be used. Each category is graded on a 5-point Likert scale ranging from no symptoms (score of 0) to severe symptoms (score of 4); a higher score indicates more severe disease.
Time Frame
Weeks 104 and 156

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 1. Has participated in and completed the ADMIRE-CD II (NCT03279081) study (i.e., did not discontinue). Exclusion Criteria: 1. Has been more than 3 months since the participant completed the ADMIRE-CD II study.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Study Director
Organizational Affiliation
Takeda
Official's Role
Study Director
Facility Information:
Facility Name
University of California San Francisco
City
San Francisco
State/Province
California
ZIP/Postal Code
94115
Country
United States
Facility Name
Cedar-Sinai Medical Center
City
West Hollywood
State/Province
California
ZIP/Postal Code
90048
Country
United States
Facility Name
Hartford Hospital - Gastroenterology
City
Farmington
State/Province
Connecticut
ZIP/Postal Code
06032
Country
United States
Facility Name
Yale University School of Medicine
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06519
Country
United States
Facility Name
Mayo Clinic - Gastroenterology
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32224
Country
United States
Facility Name
University of Miami Hospital
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Facility Name
USF Health South Tampa Center for Advanced Healthcare
City
Tampa
State/Province
Florida
ZIP/Postal Code
33606
Country
United States
Facility Name
Florida Hospital Tampa
City
Tampa
State/Province
Florida
ZIP/Postal Code
33613
Country
United States
Facility Name
Cleveland Clinic Florida
City
Weston
State/Province
Florida
ZIP/Postal Code
33331
Country
United States
Facility Name
Indiana University - Colon and Rectal
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46237
Country
United States
Facility Name
University of Kansas Sxchool of Medicine
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66160
Country
United States
Facility Name
Colon and Rectal Surgery Associates
City
Metairie
State/Province
Louisiana
ZIP/Postal Code
70001
Country
United States
Facility Name
University of Maryland
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States
Facility Name
Johns Hopkins Medicine - The Johns Hopkins Hospital
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States
Facility Name
Massachussetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
University of Massachusetts - colon & rectal surgery
City
Worcester
State/Province
Massachusetts
ZIP/Postal Code
01605
Country
United States
Facility Name
Mayo Clinic College of Medicine - Division of Colon and Rectal Surgery - Division of Colon and Rectal Surgery
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Facility Name
Barnes-Jewish Hospital - Gastroenterology
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Dartmouth Hitchcock Medical Center - Cancer Center
City
Lebanon
State/Province
New Hampshire
ZIP/Postal Code
03756
Country
United States
Facility Name
Morristown Medical Center - Gastroenterology
City
Morristown
State/Province
New Jersey
ZIP/Postal Code
07960
Country
United States
Facility Name
North Shore University Hospital - Gastroenterology
City
Manhasset
State/Province
New York
ZIP/Postal Code
11030
Country
United States
Facility Name
Icahn School of Medicine at Mount Sinai
City
New York
State/Province
New York
ZIP/Postal Code
10028
Country
United States
Facility Name
Lenox Hill Hospital
City
New York
State/Province
New York
ZIP/Postal Code
10075
Country
United States
Facility Name
Cleveland Clinic
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States
Facility Name
Penn State Hershey Medical Center - Surgery
City
Hershey
State/Province
Pennsylvania
ZIP/Postal Code
17033
Country
United States
Facility Name
University Surgical Associates-Rhode Island Hospital
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02904
Country
United States
Facility Name
Vanderbilt University Medical Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States
Facility Name
University of Utah
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84112
Country
United States
Facility Name
University of Virginia
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22908
Country
United States
Facility Name
Virginia Mason Medical Center - Gastroenterology
City
Seattle
State/Province
Washington
ZIP/Postal Code
98101
Country
United States
Facility Name
Swedish Medical Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98104
Country
United States
Facility Name
Medical College of Wisconsin Hub for Collaborative Medicine - Gastroenterology and Hepatology
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States
Facility Name
UZ Leuven - Campus Gasthuisberg
City
Leuven
State/Province
Vlaams Brabant
ZIP/Postal Code
3000
Country
Belgium
Facility Name
AZ Delta vzw - Maag-darm-leverziekten
City
Roeselare
State/Province
West-Vlaanderen
ZIP/Postal Code
8800
Country
Belgium
Facility Name
GZA ziekenhuizen - Campus Sint-Vincentius - Gastro-enterology
City
Antwerpen
ZIP/Postal Code
2018
Country
Belgium
Facility Name
UZ Gent - Gastroenterology
City
Gent
ZIP/Postal Code
9000
Country
Belgium
Facility Name
NH Hospital a.s.
City
Horovice
State/Province
Beroun
ZIP/Postal Code
268 31
Country
Czechia
Facility Name
FN Hradec Kralove
City
Hradec Kralove
ZIP/Postal Code
500 05
Country
Czechia
Facility Name
CHU de Nice
City
Nice Cedex 03
State/Province
Alpes-Maritimes
ZIP/Postal Code
06202
Country
France
Facility Name
CHU de Clermont-Ferrand - Estaing
City
Clermont-Ferrand cedex 1
State/Province
Auvergne
ZIP/Postal Code
63003
Country
France
Facility Name
Hopital Saint Louis - Gastro-hepatoenterologie
City
Paris
State/Province
Ile-de-France
ZIP/Postal Code
75010
Country
France
Facility Name
CHRU Hopital De Pontchaillou
City
Rennes
State/Province
Ille-et-Vilaine
ZIP/Postal Code
35033
Country
France
Facility Name
CHRU de Nancy -Hopital Brabois Adultes - Service d'Hepato- Gastroenterologie
City
Vandoeuvre-les-Nancy
State/Province
Lorraine
ZIP/Postal Code
54511
Country
France
Facility Name
CHRU De Lille - Hopital Claude Huriez - Hepato-Gastro-Enterologie
City
Lille
State/Province
Nord
ZIP/Postal Code
59000
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
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
Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont - I. sz. Belgyogyaszati Klinika
City
Szeged
State/Province
Csongrad
ZIP/Postal Code
6720
Country
Hungary
Facility Name
Debreceni Egyetem Klinikai Kozpont
City
Debrecen
State/Province
Hajdu-Bihar
ZIP/Postal Code
H-4032
Country
Hungary
Facility Name
MH Egeszsegugyi Kozpont - Gasztroenterologiai Osztaly
City
Budapest
State/Province
Pest
ZIP/Postal Code
1062
Country
Hungary
Facility Name
Semmelweis Egyetem
City
Budapest
State/Province
Pest
ZIP/Postal Code
H-1088
Country
Hungary
Facility Name
Rabin Med Ctr Beilinson Hosp
City
Petah Tikva
State/Province
HaMerkaz
ZIP/Postal Code
4941492
Country
Israel
Facility Name
Rambam Medical Centre
City
Haifa
State/Province
HaZafon
ZIP/Postal Code
31096
Country
Israel
Facility Name
Chaim sheba Medical Center
City
Tel Hashomer
State/Province
Tel-Aviv
ZIP/Postal Code
5262000
Country
Israel
Facility Name
Shaare Zedek Medical Center - Gastroenterology
City
Jerusalem
State/Province
Yerushalayim
ZIP/Postal Code
9103102
Country
Israel
Facility Name
Hadassah Medical Organization, Hadassah Medical Center, Ein-
City
Jerusalem
State/Province
Yerushalayim
ZIP/Postal Code
91120
Country
Israel
Facility Name
Istituto Clinico Humanitas Rozzano, IRCCS - IBD Center
City
Rozzano
State/Province
Milano
ZIP/Postal Code
20089
Country
Italy
Facility Name
AOU Policlinico di Modena - Gastroenterologia
City
Modena
ZIP/Postal Code
41124
Country
Italy
Facility Name
A.O. San Camillo Forlanini
City
Roma
ZIP/Postal Code
00152
Country
Italy
Facility Name
Complesso Integrato Columbus
City
Roma
ZIP/Postal Code
00168
Country
Italy
Facility Name
Policlinico Universitario Agostino Gemelli
City
Roma
ZIP/Postal Code
00168
Country
Italy
Facility Name
Azienda Ospedaliero Universitaria S.Maria della Misericordia - Gastroenterologia
City
Udine
ZIP/Postal Code
33100
Country
Italy
Facility Name
Centrum Medyczne Melita Medical
City
Wroclaw
State/Province
Dolnoslaskie
ZIP/Postal Code
50-449
Country
Poland
Facility Name
Wielospecjalistyczny Szpital Medicover
City
Warszawa
State/Province
Mazowieckie
ZIP/Postal Code
03-984
Country
Poland
Facility Name
Endoskopia Sp z o.o.
City
Sopot
State/Province
Pomorskie
ZIP/Postal Code
81-756
Country
Poland
Facility Name
Hospital Universitario Son Espases
City
Palma de Mallorca
State/Province
Baleares
ZIP/Postal Code
07120
Country
Spain
Facility Name
H.U. G.Trias i Pujol
City
Badalona
State/Province
Barcelona
ZIP/Postal Code
08916
Country
Spain
Facility Name
Corporacio Sanitaria Parc Tauli
City
Sabadell
State/Province
Barcelona
ZIP/Postal Code
8208
Country
Spain
Facility Name
Hospital Universitario de Fuenlabrada
City
Fuenlabrada
State/Province
Madrid
ZIP/Postal Code
28942
Country
Spain
Facility Name
Hospital Universitario Puerta de Hierro Majadahonda
City
Majadahonda
State/Province
Madrid
ZIP/Postal Code
28222
Country
Spain
Facility Name
Hospital Clinic de Barcelona
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
Facility Name
Hospital del Mar
City
Barcelona
ZIP/Postal Code
8003
Country
Spain
Facility Name
Hospital Clinico San Carlos
City
Madrid
ZIP/Postal Code
28040
Country
Spain
Facility Name
Hospital Universitario Fundacion Jimenez Diaz
City
Madrid
ZIP/Postal Code
28040
Country
Spain
Facility Name
Hospital Universitario 12 de Octubre
City
Madrid
ZIP/Postal Code
28041
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.U.V. del Rocio
City
Sevilla
ZIP/Postal Code
21005
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/
Links:
URL
https://clinicaltrials.takeda.com/study-detail/5f6b603c4db2bf003ab4a350?idFilter=%5B%22Darvadstrocel-3003%22%5D
Description
To obtain more information about this study, click this link.

Learn more about this trial

Long-term Follow-up Study With Darvadstrocel in the Treatment of Complex Perianal Fistula

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