Femme et Homme
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Extrait
The primary objective of this confirmatory, multi-center study is to compare the efficacy, defined as the proportion of subjects who are GVHD treatment successes vs. failures, of an oral BDP regimen consisting of an induction course of prednisone [1 mg/kg/day for ten (10) days] plus 8 mg/day BDP for fifty (50) days, with the efficacy of an induction course of prednisone [1 mg/kg/day for ten (10) days] plus placebo tablets for fifty (50) days, in subjects with acute gastrointestinal (GI) GVHD.
Critère d'inclusion
- Patients with acute gastrointestinal Graft Versus Host Disease