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

Completed · Phase 3 · Has a placebo group

Conditions studied: Crohn's Disease, Complex Perianal Fistula

In brief

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.

Key facts

Study ID

NCT04075825

Run by

Takeda

People needed

150

Starts

2019-11-05

Expected to finish

2024-04-02

Last updated by the study team

2025-04-23

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Has participated in and completed the ADMIRE-CD II (NCT03279081) study (i.e., did not discontinue).

You may not qualify if…

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

Where it is running

• Cedar-Sinai Medical Center — West Hollywood, California, United States
• Yale University School of Medicine — New Haven, Connecticut, United States
• Cleveland Clinic Florida — Fort Lauderdale, Florida, United States
• University of Miami Hospital — Miami, Florida, United States
• USF Health South Tampa Center for Advanced Healthcare — Tampa, Florida, United States
• AdventHealth Tampa — Tampa, Florida, United States
• Indiana University - Colon and Rectal — Indianapolis, Indiana, United States
• University of Kansas Medical Center (KUMC) - University of Kansas Liver Center - Hepatology Clinic — Kansas City, Kansas, United States
• Johns Hopkins School of Medicine — Baltimore, Maryland, United States
• Massachussetts General Hospital - Gastroenterology — Boston, Massachusetts, United States
• Mayo Clinic College of Medicine - Division of Colon and Rectal Surgery - Division of Colon and Rectal Surgery — Rochester, Minnesota, United States
• Dartmouth Hitchcock Medical Center - Cancer Center — Lebanon, New Hampshire, United States
• Morristown Medical Center - Gastroenterology — Morristown, New Jersey, United States
• Northwell Health — Manhasset, New York, United States
• Icahn School of Medicine at Mount Sinai — New York, New York, United States
• Lenox Hill Hospital — New York, New York, United States
• Penn State Hershey Medical Center - Surgery — Hershey, Pennsylvania, United States
• Brown Surgical Associates,Inc. — Providence, Rhode Island, United States
• Vanderbilt University Medical Center — Nashville, Tennessee, United States
• University of Virginia — Charlottesville, Virginia, United States
• Virginia Mason Medical Center - Gastroenterology — Seattle, Washington, United States
• Universitair Ziekenhuis Gent — Ghent, Oost-Vlaanderen, Belgium
• UZ Leuven — Leuven, Vlaams Brabant, Belgium
• GZA Sint-Vincentius — Antwerp, Belgium
• University of California San Francisco — San Francisco, California, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.