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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: Completed Phase 3 study, sponsored by Mesoblast.
NCT00562497 is a Phase 3 study that has completed, run by Mesoblast. The registered enrollment target is 192 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (75% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Treatment was considered a success if all of the following conditions were met: Achieved induction of a complete response (CR) within 28 days after first infusion; CR followed by 28 days maintenance of a clinically meaningful response defined as the response that did not require an increase in corticosteroid dose (methylprednisolone doses \>2 milligram/kilogram/day \[mg/kg/d\] or prednisone doses \>2.5 mg/kg/d) for more than 7 consecutive days; Did not require second line/escalation therapy thro
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 |
What the finished NCT00562497 record still lists
NCT00562497 is an interventional study that assigns participants to a tested intervention. The registered 192 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 (75% lower).
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT00562497 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00562497's enrollment target sits among peer trials
192 1398th of 2000 higher than 599 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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