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NCT01743131 · ClinicalTrials.gov registry record · Phase 2
Abatacept as GVHD Prophylaxis Phase 2
A Phase 2 study, sponsored by Boston Children's Hospital.
- Completed
- Registry status
- Phase 2
- Development phase
- 186
- Enrollment target
NCT01743131: Completed Phase 2 study, sponsored by Boston Children's Hospital.
NCT01743131 is a Phase 2 study that has completed, run by Boston Children's Hospital. The registered enrollment target is 186 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (40% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01743131, a Phase 2 study, has completed, sponsored by Boston Children's Hospital.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 186 participants
- Enrollment target
Study Summary
This is a phase II multi-center, randomized, double blind, placebo-controlled trial. The investigators are doing this study to see if a new drug, abatacept, can be used together with a calcineurin inhibitor (cyclosporine or tacrolimus) and methotrexate to provide better protection against Acute Graft versus Host Disease (aGvHD) without causing more infections.
Primary Outcome
The primary analysis will consist of estimating the cumulative incidence of severe aGVHD at day +100 post-transplant in the standard and investigational study arms. All registered patients will be considered for this analysis. The primary null hypothesis of the study is that there will be no difference in severe aGVHD between the investigational and standard GVHD prophylaxis arms. The primary outcome will be assessed in a final analysis to be performed after the last enrolled patient has been fo
Interventions
- DRUG placebo
- DRUG Abatacept
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 186 participants |
| Start Date | 2013-02-01 |
| Est. Completion | 2024-03-30 |
| Phase | Phase 2 |
What the finished NCT01743131 record still lists
NCT01743131 is an interventional study that assigns participants to a tested intervention. The registered 186 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (40% higher).
The record links to 0 conditions, and to 2 interventions - of which placebo is the first listed.
NCT01743131 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01743131 about?
NCT01743131 is a clinical study titled "Abatacept as GVHD Prophylaxis Phase 2". This is a phase II multi-center, randomized, double blind, placebo-controlled trial. The investigators are doing this study to see if a new drug, abatacept, can be used together with a calcineurin inhibitor (cyclosporine or tacrolimus) and methotrexate to provide better protection against Acute Gra...
What is the current status of trial NCT01743131?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 186 participants. The study started on 2013-02-01. Estimated completion is 2024-03-30.
What interventions are being tested in trial NCT01743131?
The interventions under investigation include: placebo (DRUG), Abatacept (DRUG).
Who is sponsoring clinical trial NCT01743131?
This trial is sponsored by Boston Children's Hospital, which has 462 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01743131's enrollment target sits among peer trials
186 357th of 2000 higher than 1,644 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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