Long-term Follow-up Study With Darvadstrocel in the Treatment of Complex Perianal Fistula
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.
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
Study identification
- NCT ID
- NCT04075825
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Lead sponsor
- Takeda
- Industry
- Enrollment
- 150 participants
Conditions and interventions
Conditions
Interventions
- Darvadstrocel Biological
- Placebo Other
Biological · Other
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 4, 2019
- Primary completion
- Apr 1, 2024
- Completion
- Apr 1, 2024
- Last update posted
- Apr 22, 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 22, 2025 · Synced May 17, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete protocol, eligibility criteria, and contact information for NCT04075825 live on ClinicalTrials.gov.