Title
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
Phase
Phase 3Lead Sponsor
SoligenixStudy Type
InterventionalStatus
Terminated Results PostedIndication/Condition
Acute Gastrointestinal Graft vs Host DiseaseIntervention/Treatment
beclomethasone ...Study Participants
140Use of an oral topically-active glucocorticoid with limited side effects will control the gastrointestinal inflammatory process of GVHD and minimize glucocorticoid exposure.
Two tablets QID for 50 days
Two tablets QID for 50 days
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
| Event Type | Organ System | Event Term | Active | Placebo |
|---|
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
