Long-term Follow-up Study With Darvadstrocel in the Treatment of Complex Perianal Fistula
Completed · Phase 3 · NCT04075825
Conditions: Crohn's Disease, Complex Perianal Fistula
At a glance
- Research payments reported, 2025
- $55,013
- U.S. investigators named
- 11
- Sites paid
- 11
- Planned or actual enrollment
- 150
About the trial
- Sponsor
- Takeda
- Tested
- Placebo (other), Darvadstrocel (biological)
- Dates
- Started 2019-11-05; completion 2024-04-02
- Results posted
- Yes
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.
From ClinicalTrials.gov, last updated 2025-04-23. Full record, eligibility and contacts (opens in a new tab)
Industry funding
Takeda Pharmaceuticals U.S.A., Inc. reported $55,013 in research payments for this study in 2025 (67 payments).
Research payments usually go to hospitals, universities and research sites to run a study, not to the investigators personally. A payment is not evidence of wrongdoing.
U.S. investigators named on this study
- Jill K. Gaidos, MD Gastroenterology · New Haven, CT
- Allen P. Chudzinski, M.D. Colorectal Surgery · Tampa, FL
- Giovanna Da Silva Southwick, MD Colorectal Surgery · Weston, FL
- David Kerman, M.D. Gastroenterology · Miami, FL
- Dipen C. Maun, M.D. Colorectal Surgery · Mooresville, IN
- Mojtaba S. Olyaee, M.D. Gastroenterology · Kansas City,, KS
- Laura E. Raffals, M.D. Gastroenterology · Rochester, MN
- James F. Marion, MD Gastroenterology · New York, NY
- Keith Sultan, MD Gastroenterology · Manhasset, NY
- Arun Swaminath, M.D. Gastroenterology · New York, NY
- Anne G. Tuskey, M.D. Gastroenterology · Charlottesville, VA
Clinicians the company named as principal investigators in its Open Payments reports.
Sites paid to run it
- University of Miami Hospital $12,665
- The University of South Florida Board of Trustees $8,538
- Feinstein Institute $8,160
- Biomedical Research Alliance of New York LLC $6,740
- University of Virginia Medical Center, VA $6,000
- Cleveland Clinic, OH $3,000
- Yale University $2,860
- Kumc Research Institute Inc $2,612
- Mount Sinai Hospital, NY $2,363
- Mayo Clinic Hospital Rochester, MN $1,316
- Franciscan Health Indianapolis, IN $760
Sources: CMS Open Payments research payments (program year 2025) and ClinicalTrials.gov, U.S. National Library of Medicine.