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NCT04075825 · ClinicalTrials.gov registry record · Phase 3
Long-term Follow-up Study With Darvadstrocel in the Treatment of Complex Perianal Fistula
A Phase 3 study, sponsored by Takeda.
- Completed
- Registry status
- Phase 3
- Development phase
- 150
- Enrollment target
NCT04075825: Completed Phase 3 study, sponsored by Takeda.
NCT04075825 is a Phase 3 study that has completed, run by Takeda. The registered enrollment target is 150 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (81% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04075825, a Phase 3 study, has completed, sponsored by Takeda.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 150 participants
- Enrollment target
Study 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 study.
Primary Outcome
An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered an investigational medicinal product; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (example, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug. A TEAE is defined
Interventions
- OTHER Placebo
- BIOLOGICAL Darvadstrocel
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 150 participants |
| Start Date | 2019-11-05 |
| Est. Completion | 2024-04-02 |
| Phase | Phase 3 |
What the finished NCT04075825 record still lists
NCT04075825 is an interventional study that assigns participants to a tested intervention. The registered 150 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (81% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT04075825 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04075825 about?
NCT04075825 is a clinical study titled "Long-term Follow-up Study With Darvadstrocel in the Treatment of Complex Perianal Fistula". 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.
What is the current status of trial NCT04075825?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 150 participants. The study started on 2019-11-05. Estimated completion is 2024-04-02.
What interventions are being tested in trial NCT04075825?
The interventions under investigation include: Placebo (OTHER), Darvadstrocel (BIOLOGICAL).
Who is sponsoring clinical trial NCT04075825?
This trial is sponsored by Takeda, which has 408 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04075825's enrollment target sits among peer trials
150 1519th of 2000 higher than 455 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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