Trial · NCT00926575

Study of orBec® With Prednisone Therapy in the Treatment of Patients With Graft Versus Host Disease (GVHD)

NCT00926575, Phase 3, Terminated, Soligenix; results first posted 2013-12-06

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Study of orBec® With Prednisone Therapy in the Treatment of Patients With Graft Versus Host Disease (GVHD). Trials, record NCT00926575. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00926575

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Study of orBec® With Prednisone Therapy in the Treatment of Patients With Graft Versus Host Disease (GVHD)
NCT number: NCT00926575
Status: Terminated
Phases: Phase 3
Enrollment: 140 participants, actual
Lead sponsor: Soligenix
Conditions: Acute Gastrointestinal Graft vs Host Disease
Interventions: oral beclomethasone 17,21-dipropionate, Placebo
First posted: 2009-06-23
Last updated: 2013-12-06
Results first posted: 2013-12-06
Limitations and caveats: DSMB terminated study for futility; no safety concerns during analysis of patient population. Overall, 1 SAE considered possibly related to study drug, all others were not related to study drug.

Source ClinicalTrials.gov

Registered outcomes3

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	The Proportion of Subjects With GVHD Treatment Failure	Day 80	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
Secondary	Cumulative Exposure to Prednisone	Day 80
Secondary	Survival Status	Day 200

Source ClinicalTrials.gov

Outcomes3

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population
PRIMARY	The Proportion of Subjects With GVHD Treatment Failure	Day 80	Data was not analyzed as the study was terminated due to futility
SECONDARY	Cumulative Exposure to Prednisone	Day 80
SECONDARY	Survival Status	Day 200

Source ClinicalTrials.gov

Results by group0

Each measurement the trial posted, group by group, in the words and numbers it posted.

None in this release.

Participant flow6

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Active	70
Overall Study	STARTED	Placebo	70
Overall Study	COMPLETED	Active	54
Overall Study	COMPLETED	Placebo	53
Overall Study	NOT COMPLETED	Active	16
Overall Study	NOT COMPLETED	Placebo	17

Source ClinicalTrials.gov

Adverse events350

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk
other	Anaemia	Blood and lymphatic system disorders	Active	5	70
other	Anaemia	Blood and lymphatic system disorders	Placebo	4	70
other	Neutropenia	Blood and lymphatic system disorders	Active	7	70
other	Neutropenia	Blood and lymphatic system disorders	Placebo	7	70
other	Trombocytopenia	Blood and lymphatic system disorders	Active	9	70
other	Trombocytopenia	Blood and lymphatic system disorders	Placebo	6	70
other	Tachycardia	Cardiac disorders	Active	4	70
other	Tachycardia	Cardiac disorders	Placebo	6	70
other	Adrenal insufficiency	Endocrine disorders	Active	4	70
other	Adrenal insufficiency	Endocrine disorders	Placebo	3	70

1 to 10 of 350Source ClinicalTrials.gov

See all 350 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Active
Total, all-cause mortality	Placebo
Total, other adverse events	Active	70	70
Total, other adverse events	Placebo	70	70
Total, serious adverse events	Active	32	70
Total, serious adverse events	Placebo	28	70

Source ClinicalTrials.gov

Papers2

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
9649455	BACKGROUND	PubMed
17244684	BACKGROUND	PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons1

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison
Active vs Placebo: serious adverse events

Source Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT00926575

GET https://conductscience.org/api/trials/v1/NCT00926575/events?page=2

API reference For AI assistants