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NCT03657160 · ClinicalTrials.gov registry record · Phase 3
Vedolizumab in the Prophylaxis of Intestinal Acute Graft Versus Host Disease (aGVHD) in Participants Undergoing Allogeneic Hematopoietic Stem Cell (Allo-HSCT) Transplantation
A Phase 3 study, sponsored by Millennium Pharmaceuticals.
- Completed
- Registry status
- Phase 3
- Development phase
- 343
- Enrollment target
NCT03657160: Completed Phase 3 study, sponsored by Millennium Pharmaceuticals.
NCT03657160 is a Phase 3 study that has completed, run by Millennium Pharmaceuticals. The registered enrollment target is 343 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (56% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03657160, a Phase 3 study, has completed, sponsored by Millennium Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 343 participants
- Enrollment target
Study Summary
The purpose of this study is to evaluate the efficacy of vedolizumab when added to background aGvHD prophylaxis regimen compared to placebo and background aGvHD prophylaxis regimen on intestinal aGvHD-free survival by Day +180 in participants who receive allo-HSCT as treatment for a hematologic malignancy or myeloproliferative disorder.
Primary Outcome
Intestinal aGvHD Free Survival is the time from the date of first study drug administration (Day-1) to intestinal aGvHD event/death, where an event is defined as death due to any cause or Stage 1-4 intestinal involvement per Acute Graft versus-Host Disease Clinical Stage criteria. Data was censored for participants who have not had the intestinal aGvHD event or died or have had the event after pre-specified timing, e.g., last contact or Day +180 after allo HSCT whichever occurs first.
Interventions
- DRUG Vedolizumab
- DRUG Vedolizumab Placebo
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 343 participants |
| Start Date | 2019-02-06 |
| Est. Completion | 2022-05-09 |
| Phase | Phase 3 |
What the finished NCT03657160 record still lists
NCT03657160 is an interventional study that assigns participants to a tested intervention. The registered 343 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 (56% lower).
The record links to 0 conditions, and to 2 interventions - of which Vedolizumab is the first listed.
NCT03657160 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03657160 about?
NCT03657160 is a clinical study titled "Vedolizumab in the Prophylaxis of Intestinal Acute Graft Versus Host Disease (aGVHD) in Participants Undergoing Allogeneic Hematopoietic Stem Cell (Allo-HSCT) Transplantation". The purpose of this study is to evaluate the efficacy of vedolizumab when added to background aGvHD prophylaxis regimen compared to placebo and background aGvHD prophylaxis regimen on intestinal aGvHD-free survival by Day +180 in participants who receive allo-HSCT as treatment for a hematologic mali...
What is the current status of trial NCT03657160?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 343 participants. The study started on 2019-02-06. Estimated completion is 2022-05-09.
What interventions are being tested in trial NCT03657160?
The interventions under investigation include: Vedolizumab (DRUG), Vedolizumab Placebo (DRUG).
Who is sponsoring clinical trial NCT03657160?
This trial is sponsored by Millennium Pharmaceuticals, which has 135 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03657160's enrollment target sits among peer trials
343 1051st of 2000 higher than 948 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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