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NCT00562497 · ClinicalTrials.gov registry record · Phase 3
Efficacy and Safety of Prochymal® Infusion in Combination With Corticosteroids for the Treatment of Newly Diagnosed Acute Graft Versus Host Disease (GVHD)
A Phase 3 study, sponsored by Mesoblast.
- Completed
- Registry status
- Phase 3
- Development phase
- 192
- Enrollment target
NCT00562497 is a Phase 3 study that has completed, run by Mesoblast. The registered enrollment target is 192 participants.
The verdict
NCT00562497, a Phase 3 study, has completed, sponsored by Mesoblast.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 192 participants
- Enrollment target
Study Summary
This is a Phase III, randomized, double-blind, placebo-controlled study to investigate the efficacy and safety of Prochymal® versus placebo in combination with corticosteroids as initial therapy for acute GVHD. Corticosteroids have been the primary therapy for patients with previously untreated acute GVHD and the historical published data define an expected 35% complete response (CR) at Day +28 using this therapy.
Interventions
- OTHER Placebo
- DRUG Prochymal®
- OTHER Corticosteroid
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 192 participants |
| Start Date | 2008-01-31 |
| Est. Completion | 2010-05-20 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00562497
The ClinicalTrials.gov registry entry for NCT00562497 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 192 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Mesoblast, which has 25 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT00562497 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00562497 about?
NCT00562497 is a clinical study titled "Efficacy and Safety of Prochymal® Infusion in Combination With Corticosteroids for the Treatment of Newly Diagnosed Acute Graft Versus Host Disease (GVHD)". This is a Phase III, randomized, double-blind, placebo-controlled study to investigate the efficacy and safety of Prochymal® versus placebo in combination with corticosteroids as initial therapy for acute GVHD. Corticosteroids have been the primary therapy for patients with previously untreated acut...
What is the current status of trial NCT00562497?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 192 participants. The study started on 2008-01-31. Estimated completion is 2010-05-20.
What interventions are being tested in trial NCT00562497?
The interventions under investigation include: Placebo (OTHER), Prochymal® (DRUG), Corticosteroid (OTHER).
Who is sponsoring clinical trial NCT00562497?
This trial is sponsored by Mesoblast, which has 25 total clinical trials registered on ClinicalTrials.gov.
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