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

• ClinicalTrials.gov Identifier: NCT00926575
• Recruitment Status: Terminated
• First Posted: June 23, 2009
• Results First Posted: December 6, 2013
• Last Update Posted: December 6, 2013
• Sponsor: Soligenix
• Information provided by (Responsible Party): Soligenix

Tracking Information

• First Submitted Date: June 19, 2009
• First Posted Date: June 23, 2009
• Results First Submitted Date: July 12, 2013
• Results First Posted Date: December 6, 2013
• Last Update Posted Date: December 6, 2013
• Study Start Date: October 2009
• Actual Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: October 10, 2013)

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

• Original Primary Outcome Measures (submitted: June 22, 2009): The Proportion of Subjects With GVHD Treatment Failure [ Time Frame: Day 80 ]
• Change History: Complete list of historical versions of study NCT00926575 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures (submitted: June 22, 2009)

• Cumulative Exposure to Prednisone [ Time Frame: Day 80 ]
• Survival Status [ Time Frame: Day 200 ]

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Study of orBec® With Prednisone Therapy in the Treatment of Patients With Graft Versus Host Disease (GVHD)
• 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
• 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: Interventional
• Study Phase: Phase 3
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Treatment
• Condition: Acute Gastrointestinal Graft vs Host Disease

Intervention

• 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 Arms

• Experimental: orBec®
  Investigational drug
  Intervention: Drug: oral beclomethasone 17,21-dipropionate
• Placebo Comparator: Placebo
  Control
  Intervention: Drug: Placebo

Publications *

• McDonald GB, Bouvier M, Hockenbery DM, Stern JM, Gooley T, Farrand A, Murakami C, Levine DS. Oral beclomethasone dipropionate for treatment of intestinal graft-versus-host disease: a randomized, controlled trial. Gastroenterology. 1998 Jul;115(1):28-35.
• Hockenbery DM, Cruickshank S, Rodell TC, Gooley T, Schuening F, Rowley S, David D, Brunvand M, Berryman B, Abhyankar S, Bouvier M, McDonald GB. A randomized, placebo-controlled trial of oral beclomethasone dipropionate as a prednisone-sparing therapy for gastrointestinal graft-versus-host disease. Blood. 2007 May 15;109(10):4557-63. Epub 2007 Jan 23.

Recruitment Information

• Recruitment Status: Terminated
• Actual Enrollment (submitted: April 27, 2012): 140
• Original Estimated Enrollment (submitted: June 22, 2009): 166
• Actual Study Completion Date: May 2012
• Actual Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)

Eligibility 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT00926575
• Other Study ID Numbers: BDP-GVHD-03
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Soligenix
• Study Sponsor: Soligenix
• Collaborators: Not Provided

Investigators

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

• PRS Account: Soligenix
• Verification Date: August 2013