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

Tracking Information
First Submitted Date ICMJE	June 19, 2009
First Posted Date ICMJE	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 ICMJE	October 2009
Actual Primary Completion Date	December 2011 (Final data collection date for primary outcome measure)
Current Primary Outcome Measures ICMJE; (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 ICMJE; (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 ICMJE; (submitted: June 22, 2009)	Cumulative Exposure to Prednisone [ Time Frame: Day 80 ]; Survival Status [ Time Frame: Day 200 ]
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; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, 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 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.
* 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
Actual Enrollment ICMJE; (submitted: April 27, 2012)	140
Original Estimated Enrollment ICMJE; (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 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
Sex/Gender	Sexes Eligible for Study: All
Ages	18 Years and older (Adult, Senior)
Accepts Healthy Volunteers	No
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
U.S. FDA-regulated Product	Not Provided
IPD Sharing Statement	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
PRS Account	Soligenix
Verification Date	August 2013
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP