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

This study has been terminated.

(An independent Data Safety Monitoring Board recommended the study be stopped due to futility)

Sponsor:

Information provided by (Responsible Party):

Soligenix

ClinicalTrials.gov Identifier:

NCT00926575

First received: June 19, 2009

Last updated: October 10, 2013

Last verified: August 2013

History of Changes

Tracking Information

First Received Date ^ICMJE

June 19, 2009

Last Updated Date

October 10, 2013

Start Date ^ICMJE

October 2009

Primary Completion Date

December 2011 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

The Proportion of Subjects With GVHD Treatment Failure [ Time Frame: Day 80 ] [ Designated as safety issue: No ]

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

Original Primary Outcome Measures ^ICMJE

The Proportion of Subjects With GVHD Treatment Failure [ Time Frame: Day 80 ] [ Designated as safety issue: No ]

Change History

Complete list of historical versions of study NCT00926575 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Cumulative Exposure to Prednisone [ Time Frame: Day 80 ] [ Designated as safety issue: No ]
Survival Status [ Time Frame: Day 200 ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study of the Safety and Efficacy of orBec® (Oral Beclomethasone 17,21-Dipropionate)in Conjunction With Ten Days of High-Dose Prednisone Therapy in the Treatment of Patients With Gastrointestinal GVHD

Brief Summary

Use of an oral topically-active glucocorticoid with limited side effects will control the gastrointestinal inflammatory process of GVHD and minimize glucocorticoid exposure.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 3

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment

Condition ^ICMJE

Acute Gastrointestinal Graft vs Host Disease

Intervention ^ICMJE

Drug: oral beclomethasone 17,21-dipropionate
Two tablets QID for 50 days
Other Names:
- orBec
- BDP
Drug: Placebo
Two tablets QID for 50 days

Study Arm (s)

Experimental: orBec®
Investigational drug

Intervention: Drug: oral beclomethasone 17,21-dipropionate
Placebo Comparator: Placebo
Control

Intervention: Drug: Placebo

Publications *

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Terminated

Enrollment ^ICMJE

140

Completion Date

May 2012

Primary Completion Date

December 2011 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Receipt of allogeneic hematopoietic cell transplant
Diagnosis of GI graft vs. host disease (GVHD)
No GI infection
Must be able to swallow tablets
Must be able to read and understand informed consent
Adequate birth control methods for the duration of the study

Exclusion Criteria:

Significant Skin GVHD
Liver GVHD
Persistent vomiting
HIV positive
Pregnancy/lactation

Gender

Both

Ages

18 Years and older (Adult, Senior)

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Listed Location Countries ^ICMJE

United States

Removed Location Countries

Administrative Information

NCT Number ^ICMJE

NCT00926575

Other Study ID Numbers ^ICMJE

BDP-GVHD-03

Has Data Monitoring Committee

Yes

Plan to Share Data

Not Provided

IPD Description

Not Provided

Responsible Party

Soligenix

Study Sponsor ^ICMJE

Soligenix

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:	Keith Sullivan, MD	Duke University
Principal Investigator:	David Hockenbery, MD	Fred Hutchinson Cancer Research Center

Information Provided By

Soligenix

Verification Date

August 2013

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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