Study of orBec (Registered Trademark (R)) 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(R) (Oral Beclomethasone 17,21-Dipropionate)in Conjunction With Ten Days of High-Dose Prednisone Therapy in the Treatment of Patients With Gastrointestinal Graft Versus Host Disease (GVHD)
Soligenix, Inc.
166 participants
Oct 13, 2009
Interventional
Conditions
Summary
Use of an oral topically-active glucocorticoid with limited side effects will control the gastrointestinal inflammatory process of GVHD and minimize glucocorticoid exposure.
Eligibility
Inclusion Criteria6
- Receipt of allogeneic hematopoietic cell transplant
- Diagnosis of gastrointestinal graft versus host disease (GVHD)
- No gastrointestinal (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 Criteria5
- Significant Skin Graft Versus Host Disease
- Liver Graft Versus Host Disease
- Persistent vomiting
- Human Immunodeficiency Virus (HIV) positive
- Pregnancy/lactation
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Interventions
oral beclomethasone 17,21-dipropionate Two pills (1 milligram) four times a day (8 milligrams) for 50 days. Study drug administered in conjunction with standard of care prednisone therapy.
Locations(1)
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ACTRN12610000593033