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NCT01106833 · ClinicalTrials.gov registry record · Phase 2
Chronic Graft-versus-Host Disease Treatment (BMT CTN 0801)
A Phase 2 study, sponsored by Medical College of Wisconsin.
- Completed
- Registry status
- Phase 2
- Development phase
- 151
- Enrollment target
NCT01106833 is a Phase 2 study that has completed, run by Medical College of Wisconsin. The registered enrollment target is 151 participants.
The verdict
NCT01106833, a Phase 2 study, has completed, sponsored by Medical College of Wisconsin.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 151 participants
- Enrollment target
Study Summary
This study is designed as a combined Phase II/III, randomized, open label, multicenter, prospective comparative study of sirolimus plus prednisone versus sirolimus/calcineurin-inhibitor plus prednisone for the treatment of chronic GVHD. Patients will be stratified by transplant center and will be randomized to an experimental arm of one of the two pre-specified experimental arms (sirolimus + prednisone or the comparator arm of sirolimus + calcineurin inhibitor + prednisone) in a 1:1 ratio.
Interventions
- DRUG Sirolimus + calcineurin inhibitor + prednisone
- DRUG Sirolimus + prednisone
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 151 participants |
| Start Date | 2010-04 |
| Est. Completion | 2018-06 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01106833
The ClinicalTrials.gov registry entry for NCT01106833 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 151 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Medical College of Wisconsin, which has 447 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Sirolimus + calcineurin inhibitor + prednisone is the first listed.
NCT01106833 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01106833 about?
NCT01106833 is a clinical study titled "Chronic Graft-versus-Host Disease Treatment (BMT CTN 0801)". This study is designed as a combined Phase II/III, randomized, open label, multicenter, prospective comparative study of sirolimus plus prednisone versus sirolimus/calcineurin-inhibitor plus prednisone for the treatment of chronic GVHD. Patients will be stratified by transplant center and will be ra...
What is the current status of trial NCT01106833?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 151 participants. The study started on 2010-04. Estimated completion is 2018-06.
What interventions are being tested in trial NCT01106833?
The interventions under investigation include: Sirolimus + calcineurin inhibitor + prednisone (DRUG), Sirolimus + prednisone (DRUG).
Who is sponsoring clinical trial NCT01106833?
This trial is sponsored by Medical College of Wisconsin, which has 447 total clinical trials registered on ClinicalTrials.gov.
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