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.

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