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

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ClinicalTrials.gov 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
Sponsor:
Information provided by (Responsible Party):
Soligenix

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

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
Control
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 ]


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

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 ClinicalTrials.gov identifier (NCT number): NCT00926575


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

Publications:
Responsible Party: Soligenix
ClinicalTrials.gov Identifier: NCT00926575     History of Changes
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:
BDP
orBec
GVHD
beclomethasone dipropionate
bone marrow transplant
hematopoietic cell transplant
HCT
stem cell transplant
marrow transplant
SCT
beclomethasone 17,21-dipropionate

Additional relevant MeSH terms:
Graft vs Host Disease
Immune System Diseases
Prednisone
Beclomethasone
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Anti-Asthmatic Agents
Respiratory System Agents