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Completed Phase 3 Interventional Results available

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

ClinicalTrials.gov ID: NCT04075825

Public ClinicalTrials.gov record NCT04075825. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Oct 22, 2026, 11:04 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

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

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID
NCT04075825
Recruitment status
Completed
Study type
Interventional
Phase
Phase 3
Lead sponsor
Takeda
Industry
Enrollment
150 participants

Conditions and interventions

Interventions

Other · Biological

Eligibility (public fields only)

Age range
18 Years and older
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Nov 5, 2019 (Actual)
Primary completion
Apr 2, 2024 (Actual)
Completion
Apr 2, 2024 (Actual)
Last update posted
Apr 23, 2025

2019 – 2024

United States locations

U.S. sites
22
U.S. states
16
U.S. cities
20
Facility City State ZIP Site status
University of California San Francisco San Francisco California 94115 —
Cedar-Sinai Medical Center West Hollywood California 90048 —
Yale University School of Medicine New Haven Connecticut 06510 —
Cleveland Clinic Florida Fort Lauderdale Florida 33331 —
University of Miami Hospital Miami Florida 33136 —
USF Health South Tampa Center for Advanced Healthcare Tampa Florida 33606 —
AdventHealth Tampa Tampa Florida 33613 —
Indiana University - Colon and Rectal Indianapolis Indiana 46237 —
University of Kansas Medical Center (KUMC) - University of Kansas Liver Center - Hepatology Clinic Kansas City Kansas 66160 —
Johns Hopkins School of Medicine Baltimore Maryland 21205 —
Massachussetts General Hospital - Gastroenterology Boston Massachusetts 02114 —
Mayo Clinic College of Medicine - Division of Colon and Rectal Surgery - Division of Colon and Rectal Surgery Rochester Minnesota 55905 —
Dartmouth Hitchcock Medical Center - Cancer Center Lebanon New Hampshire 03576 —
Morristown Medical Center - Gastroenterology Morristown New Jersey 07960 —
Northwell Health Manhasset New York 11030 —
Icahn School of Medicine at Mount Sinai New York New York 10029 —
Lenox Hill Hospital New York New York 10075 —
Penn State Hershey Medical Center - Surgery Hershey Pennsylvania 17033 —
Brown Surgical Associates,Inc. Providence Rhode Island 02904 —
Vanderbilt University Medical Center Nashville Tennessee 37212 —
University of Virginia Charlottesville Virginia 22908 —
Virginia Mason Medical Center - Gastroenterology Seattle Washington 98101 —

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 36 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT04075825, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Apr 23, 2025 · Synced Oct 22, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT04075825 live on ClinicalTrials.gov.

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