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:
Soligenix
Information provided by (Responsible Party):
Soligenix
ClinicalTrials.gov Identifier:
NCT00926575
First received: June 19, 2009
Last updated: October 10, 2013
Last verified: August 2013
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| Tracking Information | |||||||||
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| First Received Date ICMJE | June 19, 2009 | ||||||||
| Last Updated Date | October 10, 2013 | ||||||||
| Start Date ICMJE | October 2009 | ||||||||
| 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 ] [ 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 |
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| Original Primary Outcome Measures ICMJE |
The proportion of subjects with GVHD treatment failure [ Time Frame: Day 80 ] [ Designated as safety issue: No ] | ||||||||
| Change History | Complete list of historical versions of study NCT00926575 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE |
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| 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. |
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| Detailed Description | Not Provided | ||||||||
| Study Type ICMJE | Interventional | ||||||||
| Study Phase | Phase 3 | ||||||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
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| Condition ICMJE | Acute Gastrointestinal Graft vs Host Disease | ||||||||
| Intervention ICMJE |
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| Study Arm (s) |
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| Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Terminated | ||||||||
| Enrollment ICMJE | 140 | ||||||||
| Completion Date | May 2012 | ||||||||
| Primary Completion Date | December 2011 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | 18 Years and older | ||||||||
| 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 | ||||||||
| Responsible Party | Soligenix | ||||||||
| Study Sponsor ICMJE | Soligenix | ||||||||
| Collaborators ICMJE | Not Provided | ||||||||
| Investigators ICMJE |
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| Information Provided By | Soligenix | ||||||||
| Verification Date | August 2013 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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