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
Plain Language Summary
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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