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

This study has been terminated.
(An independent Data Safety Monitoring Board recommended the study be stopped due to futility)
Sponsor:
Information provided by (Responsible Party):
Soligenix
ClinicalTrials.gov Identifier:
NCT00926575
First received: June 19, 2009
Last updated: October 10, 2013
Last verified: August 2013

June 19, 2009
October 10, 2013
October 2009
December 2011   (final data collection date for primary outcome measure)
The Proportion of Subjects With GVHD Treatment Failure [ Time Frame: Day 80 ] [ Designated as safety issue: No ]
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
The proportion of subjects with GVHD treatment failure [ Time Frame: Day 80 ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00926575 on ClinicalTrials.gov Archive Site
  • Cumulative Exposure to Prednisone [ Time Frame: Day 80 ] [ Designated as safety issue: No ]
  • Survival Status [ Time Frame: Day 200 ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Study of orBec® With Prednisone Therapy in the Treatment of Patients With Graft Versus Host Disease (GVHD)
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

Use of an oral topically-active glucocorticoid with limited side effects will control the gastrointestinal inflammatory process of GVHD and minimize glucocorticoid exposure.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Acute Gastrointestinal Graft vs Host Disease
  • Drug: oral beclomethasone 17,21-dipropionate
    Two tablets QID for 50 days
    Other Names:
    • orBec
    • BDP
  • Drug: Placebo
    Two tablets QID for 50 days
    Other Name: Placebo
  • Experimental: orBec®
    Investigational drug
    Intervention: Drug: oral beclomethasone 17,21-dipropionate
  • Placebo Comparator: Placebo
    Control
    Intervention: Drug: Placebo

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
140
May 2012
December 2011   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00926575
BDP-GVHD-03
Yes
Soligenix
Soligenix
Not Provided
Principal Investigator: Keith Sullivan, MD Duke University
Principal Investigator: David Hockenbery, MD Fred Hutchinson Cancer Research Center
Soligenix
August 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP