NCT04075825CompletedPhase 3
Long-term Follow-up Study With Darvadstrocel in the Treatment of Complex Perianal Fistula
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
Source: ClinicalTrials.gov · Last updated 23 Apr 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 150 (actual)
- First submitted
- 22 Aug 2019
- Start date
- 5 Nov 2019
- Primary completion date
- 2 Apr 2024
- Lead sponsor
- Takeda
- Diseases
- Crohn's disease
- NCT number
- NCT04075825
- EudraCT number
- 2019-000333-39
What you commit to
- Study type: Interventional · Phase 3
- Participants enrolled: 150
- From 5 Nov 2019 to the primary completion date, 2 Apr 2024
- 58 sites in 9 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other
- 1\. Has been more than 3 months since the participant completed the ADMIRE-CD II study.
Who the study is looking for
- 1\. Has participated in and completed the ADMIRE-CD II (NCT03279081) study (i.e., did not discontinue).
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (58)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| GZA Sint-Vincentius Coordinator of this site? Confirm its status | Antwerp | Belgium | Unknown status |
| Universitair Ziekenhuis Gent Coordinator of this site? Confirm its status | Ghent | Belgium | Unknown status |
| UZ Leuven Coordinator of this site? Confirm its status | Leuven | Belgium | Unknown status |
| NH Hospital a.s. Coordinator of this site? Confirm its status | Hořovice | Czechia | Unknown status |
| FN Hradec Kralove Coordinator of this site? Confirm its status | Hradec Králové | Czechia | Unknown status |
| H.U. G.Trias i Pujol Coordinator of this site? Confirm its status | Badalona | Spain | Unknown status |
| Hospital del Mar Coordinator of this site? Confirm its status | Barcelona | Spain | Unknown status |
| Hospital Clinic de Barcelona Coordinator of this site? Confirm its status | Barcelona | Spain | Unknown status |
| Hospital Universitario de Fuenlabrada Coordinator of this site? Confirm its status | Fuenlabrada | Spain | Unknown status |
| Hospital Clínico San Carlos Coordinator of this site? Confirm its status | Madrid | Spain | Unknown status |
| Fundación Jiménez Díaz Coordinator of this site? Confirm its status | Madrid | Spain | Unknown status |
| Hospital Universitario 12 de Octubre Coordinator of this site? Confirm its status | Madrid | Spain | Unknown status |
| Hospital Universitario Son Espases Coordinator of this site? Confirm its status | Palma de Mallorca | Spain | Unknown status |
| C.H.U. de Pontevedra Coordinator of this site? Confirm its status | Pontevedra | Spain | Unknown status |
| Parc Tauli Hospital Universitari Coordinator of this site? Confirm its status | Sabadell | Spain | Unknown status |
| H.U.V. del Rocio Coordinator of this site? Confirm its status | Seville | Spain | Unknown status |
| CHU de Clermont-Ferrand - Estaing Coordinator of this site? Confirm its status | Clermont-Ferrand | France | Unknown status |
| CHRU de Lille - Hopital Claude Huriez - Gastroenterologie Coordinator of this site? Confirm its status | Lille | France | Unknown status |
| Paris St. Joseph Hospital Coordinator of this site? Confirm its status | Paris | France | Unknown status |
| Hopital Saint Louis Coordinator of this site? Confirm its status | Paris | France | Unknown status |
| Centre Hospitalier Lyon-Sud Coordinator of this site? Confirm its status | Pierre-Bénite | France | Unknown status |
| CHRU Hopital de Pontchaillou - Maladies De L'Appareil Digesti Coordinator of this site? Confirm its status | Rennes | France | Unknown status |
| CHRU de Brabois Hopitaux de Brabois Coordinator of this site? Confirm its status | Vandœuvre-lès-Nancy | France | Unknown status |
| Semmelweis Egyetem Általános Orvostudományi Kar Coordinator of this site? Confirm its status | Budapest | Hungary | Unknown status |
| MH Egészségügyi Központ Coordinator of this site? Confirm its status | Budapest | Hungary | Unknown status |
| Debreceni Egyetem Klinikai Kozpont Nagyerdei Campus Gyermekgyogyaszati Klinika Coordinator of this site? Confirm its status | Debrecen | Hungary | Unknown status |
| Szegedi Tudomanyegyetem Altalanos Orvostudomanyi Kar Coordinator of this site? Confirm its status | Szeged | Hungary | Unknown status |
| Rambam Medical Centre Coordinator of this site? Confirm its status | Haifa | Israel | Unknown status |
| Hadassah Medical Organization, Hadassah Medical Center, Ein- Coordinator of this site? Confirm its status | Jerusalem | Israel | Unknown status |
| Rabin Medical Center, Beilinson Hospital -Gastroenterology Coordinator of this site? Confirm its status | Petah Tikva | Israel | Unknown status |
| The Chaim Sheba Medical Center Coordinator of this site? Confirm its status | Tel-Hashomer | Israel | Unknown status |
| AOU Policlinico di Modena - Gastroenterologia Coordinator of this site? Confirm its status | Modena | Italy | Unknown status |
| PU A. Gemelli, Universita Cattolica del Sacro Cuore Coordinator of this site? Confirm its status | Roma | Italy | Unknown status |
| Complesso Integrato Columbus, Universita Cattolica del Sacro Cuore Coordinator of this site? Confirm its status | Roma | Italy | Unknown status |
| Wielospecjalistyczny Szpital Medicover Coordinator of this site? Confirm its status | Warsaw | Poland | Unknown status |
| Centrum Medyczne Melita Medical Coordinator of this site? Confirm its status | Wroclaw | Poland | Unknown status |
| Johns Hopkins School of Medicine Coordinator of this site? Confirm its status | Baltimore | United States | Unknown status |
| Massachussetts General Hospital - Gastroenterology Coordinator of this site? Confirm its status | Boston | United States | Unknown status |
| University of Virginia Coordinator of this site? Confirm its status | Charlottesville | United States | Unknown status |
| Cleveland Clinic Florida Coordinator of this site? Confirm its status | Fort Lauderdale | United States | Unknown status |
| Penn State Hershey Medical Center - Surgery Coordinator of this site? Confirm its status | Hershey | United States | Unknown status |
| Indiana University - Colon and Rectal Coordinator of this site? Confirm its status | Indianapolis | United States | Unknown status |
| University of Kansas Medical Center (KUMC) - University of Kansas Liver Center - Hepatology Clinic Coordinator of this site? Confirm its status | Kansas City | United States | Unknown status |
| Dartmouth Hitchcock Medical Center - Cancer Center Coordinator of this site? Confirm its status | Lebanon | United States | Unknown status |
| Northwell Health Coordinator of this site? Confirm its status | Manhasset | United States | Unknown status |
| University of Miami Hospital Coordinator of this site? Confirm its status | Miami | United States | Unknown status |
| Morristown Medical Center - Gastroenterology Coordinator of this site? Confirm its status | Morristown | United States | Unknown status |
| Vanderbilt University Medical Center Coordinator of this site? Confirm its status | Nashville | United States | Unknown status |
| Yale University School Of Medicine Coordinator of this site? Confirm its status | New Haven | United States | Unknown status |
| Icahn School of Medicine at Mount Sinai Coordinator of this site? Confirm its status | New York | United States | Unknown status |
| Lenox Hill Hospital Coordinator of this site? Confirm its status | New York | United States | Unknown status |
| Brown Surgical Associates,Inc. Coordinator of this site? Confirm its status | Providence | United States | Unknown status |
| Mayo Clinic College of Medicine - Division of Colon and Rectal Surgery - Division of Colon and Rectal Surgery Coordinator of this site? Confirm its status | Rochester | United States | Unknown status |
| University of California San Francisco Coordinator of this site? Confirm its status | San Francisco | United States | Unknown status |
| Virginia Mason Medical Center - Gastroenterology Coordinator of this site? Confirm its status | Seattle | United States | Unknown status |
| USF Health South Tampa Center for Advanced Healthcare Coordinator of this site? Confirm its status | Tampa | United States | Unknown status |
| AdventHealth Tampa Coordinator of this site? Confirm its status | Tampa | United States | Unknown status |
| Cedar-Sinai Medical Center Coordinator of this site? Confirm its status | West Hollywood | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.