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NCT01925950 · ClinicalTrials.gov registry record · Phase 2
Study of orBec® as Monotherapy in the Treatment of Patients With Upper GI Symptoms Caused by Chronic Graft Versus Host Disease (GVHD)
A Phase 2 study, sponsored by Soligenix.
- Terminated
- Registry status
- Phase 2
- Development phase
- 2
- Enrollment target
NCT01925950: Clinical Trial Phase 2 study, sponsored by Soligenix.
NCT01925950 is a Phase 2 study that was terminated before completion, run by Soligenix. The registered enrollment target is 2 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (98% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01925950, a Phase 2 study, was terminated before completion, sponsored by Soligenix.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 2 participants
- Enrollment target
Study Summary
Use of an oral topically-active glucocorticoid with limited side effects may control the gastrointestinal inflammatory process of GVHD and minimize glucocorticoid exposure.
Primary Outcome
Patients who achieved a Complete Response (CR) of their GI GVHD Symptoms during the Part 1, 16 week treatment period and who remained a CR at the end of the 16 week treatment period were to be eligible to continue into Part 2 of the study. All others were to discontinue. GI GVHD was assessed using a composite score based on the symptoms of satiety, nausea/vomiting, and anorexia. Each symptom was scored on a scale of 0-3, such that the minimum score = 0 and the maximum score = 9. At entry, all s
Interventions
- DRUG Placebo
- DRUG orBec
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 2 participants |
| Start Date | 2013-12 |
| Est. Completion | 2015-05 |
| Phase | Phase 2 |
Why NCT01925950 stopped before completion
NCT01925950 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 2 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (98% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT01925950 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01925950 about?
NCT01925950 is a clinical study titled "Study of orBec® as Monotherapy in the Treatment of Patients With Upper GI Symptoms Caused by Chronic Graft Versus Host Disease (GVHD)". Use of an oral topically-active glucocorticoid with limited side effects may control the gastrointestinal inflammatory process of GVHD and minimize glucocorticoid exposure.
What is the current status of trial NCT01925950?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 2 participants. The study started on 2013-12. Estimated completion is 2015-05.
What interventions are being tested in trial NCT01925950?
The interventions under investigation include: Placebo (DRUG), orBec (DRUG).
Who is sponsoring clinical trial NCT01925950?
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 NCT01925950's enrollment target sits among peer trials
2 2001st of 2000 the lowest 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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