Study of orBec® With Prednisone Therapy in the Treatment of Patients With Graft Versus Host Disease (GVHD)
Phase 3
Terminated
- Conditions
- Acute Gastrointestinal Graft vs Host Disease
- Interventions
- Drug: oral beclomethasone 17,21-dipropionateDrug: Placebo
- Registration Number
- NCT00926575
- Lead Sponsor
- Soligenix
- 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 available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 140
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description orBec® oral beclomethasone 17,21-dipropionate Investigational drug Placebo Placebo Control
- Primary Outcome Measures
Name Time Method The Proportion of Subjects With GVHD Treatment Failure 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
- Secondary Outcome Measures
Name Time Method Cumulative Exposure to Prednisone Day 80 Survival Status Day 200