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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

Tracking Information
First Submitted Date  ICMJE June 19, 2009
First Posted Date  ICMJE June 23, 2009
Results First Submitted Date  ICMJE July 12, 2013
Results First Posted Date  ICMJE 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 Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures 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  ICMJE 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  ICMJE
  • 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
Actual Enrollment  ICMJE
 (submitted: April 27, 2012)
140
Original Estimated Enrollment  ICMJE
 (submitted: June 22, 2009)
166
Actual Study Completion Date  ICMJE 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  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE 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  ICMJE 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