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NCT02728895 · ClinicalTrials.gov registry record · Phase 1
Dose Finding Study of Vedolizumab for GvHD in Participants Undergoing Allogeneic HSCT
A Phase 1 study, sponsored by Takeda.
- Completed
- Registry status
- Phase 1
- Development phase
- 24
- Enrollment target
NCT02728895: Completed Phase 1 study, sponsored by Takeda.
NCT02728895 is a Phase 1 study that has completed, run by Takeda. The registered enrollment target is 24 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (60% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02728895, a Phase 1 study, has completed, sponsored by Takeda.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 24 participants
- Enrollment target
Study Summary
The purpose of this study is to assess the initial tolerability, safety and recommended phase 2 dose of vedolizumab intravenous (IV) administered for GvHD prophylaxis along with standard GvHD prophylaxis therapy (in participants undergoing allogeneic hematopoietic stem cell transplantation \[allo-HSCT\]).
Primary Outcome
DLTs was based on National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.03 and was defined as any of following events: Grade 3 or higher toxicity assessed by the investigator as related to vedolizumab treatment; Grade 4 or higher regimen-related organ toxicities; and failure to engraft by Day +28. Engraftment was defined as absolute neutrophils count (ANC) greater than (\>) 500 per cubic millimeter (/mm\^3) for 3 consecutive days or \>2000/mm\^3 for 1 day
Interventions
- DRUG Vedolizumab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 24 participants |
| Start Date | 2016-06-15 |
| Est. Completion | 2018-07-10 |
| Phase | Phase 1 |
What the finished NCT02728895 record still lists
NCT02728895 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 24 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (60% lower).
The record links to 0 conditions, and to 1 intervention - of which Vedolizumab is the first listed.
NCT02728895 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02728895 about?
NCT02728895 is a clinical study titled "Dose Finding Study of Vedolizumab for GvHD in Participants Undergoing Allogeneic HSCT". The purpose of this study is to assess the initial tolerability, safety and recommended phase 2 dose of vedolizumab intravenous (IV) administered for GvHD prophylaxis along with standard GvHD prophylaxis therapy (in participants undergoing allogeneic hematopoietic stem cell transplantation \[allo-HS...
What is the current status of trial NCT02728895?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 24 participants. The study started on 2016-06-15. Estimated completion is 2018-07-10.
What interventions are being tested in trial NCT02728895?
The interventions under investigation include: Vedolizumab (DRUG).
Who is sponsoring clinical trial NCT02728895?
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 NCT02728895's enrollment target sits among peer trials
24 1520th of 2000 higher than 405 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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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