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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
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

Full criteria on ClinicalTrials.gov

Sites (58)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
GZA Sint-Vincentius
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AntwerpBelgiumUnknown status
Universitair Ziekenhuis Gent
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GhentBelgiumUnknown status
UZ Leuven
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LeuvenBelgiumUnknown status
NH Hospital a.s.
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HořoviceCzechiaUnknown status
FN Hradec Kralove
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Hradec KrálovéCzechiaUnknown status
H.U. G.Trias i Pujol
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BadalonaSpainUnknown status
Hospital del Mar
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BarcelonaSpainUnknown status
Hospital Clinic de Barcelona
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BarcelonaSpainUnknown status
Hospital Universitario de Fuenlabrada
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FuenlabradaSpainUnknown status
Hospital Clínico San Carlos
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MadridSpainUnknown status
Fundación Jiménez Díaz
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MadridSpainUnknown status
Hospital Universitario 12 de Octubre
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MadridSpainUnknown status
Hospital Universitario Son Espases
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Palma de MallorcaSpainUnknown status
C.H.U. de Pontevedra
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PontevedraSpainUnknown status
Parc Tauli Hospital Universitari
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SabadellSpainUnknown status
H.U.V. del Rocio
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SevilleSpainUnknown status
CHU de Clermont-Ferrand - Estaing
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Clermont-FerrandFranceUnknown status
CHRU de Lille - Hopital Claude Huriez - Gastroenterologie
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LilleFranceUnknown status
Paris St. Joseph Hospital
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ParisFranceUnknown status
Hopital Saint Louis
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ParisFranceUnknown status
Centre Hospitalier Lyon-Sud
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Pierre-BéniteFranceUnknown status
CHRU Hopital de Pontchaillou - Maladies De L'Appareil Digesti
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RennesFranceUnknown status
CHRU de Brabois Hopitaux de Brabois
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Vandœuvre-lès-NancyFranceUnknown status
Semmelweis Egyetem Általános Orvostudományi Kar
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BudapestHungaryUnknown status
MH Egészségügyi Központ
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BudapestHungaryUnknown status
Debreceni Egyetem Klinikai Kozpont Nagyerdei Campus Gyermekgyogyaszati Klinika
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DebrecenHungaryUnknown status
Szegedi Tudomanyegyetem Altalanos Orvostudomanyi Kar
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SzegedHungaryUnknown status
Rambam Medical Centre
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HaifaIsraelUnknown status
Hadassah Medical Organization, Hadassah Medical Center, Ein-
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JerusalemIsraelUnknown status
Rabin Medical Center, Beilinson Hospital -Gastroenterology
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Petah TikvaIsraelUnknown status
The Chaim Sheba Medical Center
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Tel-HashomerIsraelUnknown status
AOU Policlinico di Modena - Gastroenterologia
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ModenaItalyUnknown status
PU A. Gemelli, Universita Cattolica del Sacro Cuore
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RomaItalyUnknown status
Complesso Integrato Columbus, Universita Cattolica del Sacro Cuore
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RomaItalyUnknown status
Wielospecjalistyczny Szpital Medicover
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WarsawPolandUnknown status
Centrum Medyczne Melita Medical
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WroclawPolandUnknown status
Johns Hopkins School of Medicine
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BaltimoreUnited StatesUnknown status
Massachussetts General Hospital - Gastroenterology
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BostonUnited StatesUnknown status
University of Virginia
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CharlottesvilleUnited StatesUnknown status
Cleveland Clinic Florida
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Fort LauderdaleUnited StatesUnknown status
Penn State Hershey Medical Center - Surgery
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HersheyUnited StatesUnknown status
Indiana University - Colon and Rectal
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IndianapolisUnited StatesUnknown status
University of Kansas Medical Center (KUMC) - University of Kansas Liver Center - Hepatology Clinic
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Kansas CityUnited StatesUnknown status
Dartmouth Hitchcock Medical Center - Cancer Center
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LebanonUnited StatesUnknown status
Northwell Health
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ManhassetUnited StatesUnknown status
University of Miami Hospital
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MiamiUnited StatesUnknown status
Morristown Medical Center - Gastroenterology
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MorristownUnited StatesUnknown status
Vanderbilt University Medical Center
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NashvilleUnited StatesUnknown status
Yale University School Of Medicine
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New HavenUnited StatesUnknown status
Icahn School of Medicine at Mount Sinai
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New YorkUnited StatesUnknown status
Lenox Hill Hospital
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New YorkUnited StatesUnknown status
Brown Surgical Associates,Inc.
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ProvidenceUnited StatesUnknown status
Mayo Clinic College of Medicine - Division of Colon and Rectal Surgery - Division of Colon and Rectal Surgery
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RochesterUnited StatesUnknown status
University of California San Francisco
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San FranciscoUnited StatesUnknown status
Virginia Mason Medical Center - Gastroenterology
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SeattleUnited StatesUnknown status
USF Health South Tampa Center for Advanced Healthcare
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TampaUnited StatesUnknown status
AdventHealth Tampa
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TampaUnited StatesUnknown status
Cedar-Sinai Medical Center
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West HollywoodUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.