Study of orBec® With Prednisone Therapy in the Treatment of Patients With Graft Versus Host Disease (GVHD)

• Status: Terminated
• Trial end date: 2012-05-01
• Target enrollment: 0
• Participant gender: All

Summary

Use of an oral topically-active glucocorticoid with limited side effects will control the gastrointestinal inflammatory process of GVHD and minimize glucocorticoid exposure.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Soligenix
• Treatments: Beclomethasone; Prednisone

Criteria

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