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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00926575
Recruitment Status : Terminated (An independent Data Safety Monitoring Board recommended the study be stopped due to futility)
First Posted : June 23, 2009
Results First Posted : December 6, 2013
Last Update Posted : December 6, 2013
Information provided by (Responsible Party):

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.

Condition or disease Intervention/treatment Phase
Acute Gastrointestinal Graft vs Host Disease Drug: oral beclomethasone 17,21-dipropionate Drug: Placebo Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 140 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : October 2009
Actual Primary Completion Date : December 2011
Actual Study Completion Date : May 2012

Arm Intervention/treatment
Experimental: orBec®
Investigational drug
Drug: oral beclomethasone 17,21-dipropionate
Two tablets QID for 50 days
Other Names:
  • orBec
  • BDP

Placebo Comparator: Placebo
Drug: Placebo
Two tablets QID for 50 days

Primary Outcome Measures :
  1. The Proportion of Subjects With GVHD Treatment Failure [ Time Frame: 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 Outcome Measures :
  1. Cumulative Exposure to Prednisone [ Time Frame: Day 80 ]
  2. Survival Status [ Time Frame: Day 200 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00926575

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United States, New York
Buffalo, New York, United States
United States, North Carolina
Durham, North Carolina, United States
United States, Washington
Seattle, Washington, United States
Sponsors and Collaborators
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Principal Investigator: Keith Sullivan, MD Duke University
Principal Investigator: David Hockenbery, MD Fred Hutchinson Cancer Research Center
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Responsible Party: Soligenix Identifier: NCT00926575    
Other Study ID Numbers: BDP-GVHD-03
First Posted: June 23, 2009    Key Record Dates
Results First Posted: December 6, 2013
Last Update Posted: December 6, 2013
Last Verified: August 2013
Keywords provided by Soligenix:
beclomethasone dipropionate
bone marrow transplant
hematopoietic cell transplant
stem cell transplant
marrow transplant
beclomethasone 17,21-dipropionate
Additional relevant MeSH terms:
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Graft vs Host Disease
Immune System Diseases
Anti-Inflammatory Agents
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents