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NCT00926575 · ClinicalTrials.gov registry record · Phase 3
Study of orBec® With Prednisone Therapy in the Treatment of Patients With Graft Versus Host Disease (GVHD)
A Phase 3 study, sponsored by Soligenix.
- Terminated
- Registry status
- Phase 3
- Development phase
- 140
- Enrollment target
NCT00926575: Clinical Trial Phase 3 study, sponsored by Soligenix.
NCT00926575 is a Phase 3 study that was terminated before completion, run by Soligenix. The registered enrollment target is 140 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (82% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00926575, a Phase 3 study, was terminated before completion, sponsored by Soligenix.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 140 participants
- Enrollment target
Study Summary
Use of an oral topically-active glucocorticoid with limited side effects will control the gastrointestinal inflammatory process of GVHD and minimize glucocorticoid exposure.
Primary Outcome
The primary endpoint is the occurrence (yes, no) during the 80-day study period of GVHD treatment failure defined as use of prednisone or equivalent IV corticosteroids at doses higher than stated in the protocol, or use of any additional other glucocorticoid (including unblinded BDP) or addition of other immunosuppressant medications, in response to uncontrolled signs or symptoms of GVHD
Interventions
- DRUG Placebo
- DRUG oral beclomethasone 17,21-dipropionate
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 140 participants |
| Start Date | 2009-10 |
| Est. Completion | 2012-05 |
| Phase | Phase 3 |
Why NCT00926575 stopped before completion
NCT00926575 is an interventional study that assigns participants to a tested intervention. The registered 140 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 (82% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT00926575 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00926575 about?
NCT00926575 is a clinical study titled "Study of orBec® With Prednisone Therapy in the Treatment of Patients With Graft Versus Host Disease (GVHD)". Use of an oral topically-active glucocorticoid with limited side effects will control the gastrointestinal inflammatory process of GVHD and minimize glucocorticoid exposure.
What is the current status of trial NCT00926575?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 140 participants. The study started on 2009-10. Estimated completion is 2012-05.
What interventions are being tested in trial NCT00926575?
The interventions under investigation include: Placebo (DRUG), oral beclomethasone 17,21-dipropionate (DRUG).
Who is sponsoring clinical trial NCT00926575?
This trial is sponsored by Soligenix, which has 10 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00926575's enrollment target sits among peer trials
140 1565th of 2000 higher than 424 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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