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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.

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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

FieldValue
Enrollment Target 140 participants
Start Date 2009-10
Est. Completion 2012-05
Phase Phase 3
Soligenix

10 total trials

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.

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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Source: ClinicalTrials.gov NCT00926575, the US trial registry maintained by the National Library of Medicine. NCT00926575 (mid enrollment · none site footprint · terminated) retrieved and formatted by PlainTrial, see methodology.