Study of orBec® With Prednisone Therapy in the Treatment of Patients With Graft Versus Host Disease (GVHD) (SUPPORTS)
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
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:
Soligenix
Information provided by (Responsible Party):
Soligenix
- Study Details
- Tabular View
- Study Results
- Disclaimer
- How to Read a Study Record
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 |
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 |
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 |
|
||||||
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 |
|
||||||
Study Arms |
|
||||||
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 |
140 | ||||||
Original Estimated Enrollment ICMJE |
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:
Exclusion Criteria:
|
||||||
Sex/Gender |
|
||||||
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 |
|
||||||
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 |