Status:
COMPLETED
Long-term Follow-up Study With Darvadstrocel in the Treatment of Complex Perianal Fistula
Lead Sponsor:
Takeda
Conditions:
Crohn's Disease
Complex Perianal Fistula
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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 st...
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...
Eligibility Criteria
Inclusion
- 1\. Has participated in and completed the ADMIRE-CD II (NCT03279081) study (i.e., did not discontinue).
Exclusion
- 1\. Has been more than 3 months since the participant completed the ADMIRE-CD II study.
Key Trial Info
Start Date :
November 5 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 2 2024
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT04075825
Start Date
November 5 2019
End Date
April 2 2024
Last Update
April 23 2025
Active Locations (58)
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1
University of California San Francisco
San Francisco, California, United States, 94115
2
Cedar-Sinai Medical Center
West Hollywood, California, United States, 90048
3
Yale University School of Medicine
New Haven, Connecticut, United States, 06510
4
Cleveland Clinic Florida
Fort Lauderdale, Florida, United States, 33331