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A PHASE 3, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTI-CENTER STUDY OF THE SAFETY AND EFFICACY OF ORBEC® (ORAL BECLOMETHASONE 17,21-DIPROPIONATE) IN CONJUNCTION WITH TEN DAYS OF HIGH-DOSE PRED...

Update Il y a 4 ans
Reference: EUCTR2010-022247-37

A PHASE 3, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTI-CENTER 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 GRAFT VS. HOST DISEASE

Woman and Man

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Extract

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.

Inclusion criteria

  • Patients with acute gastrointestinal Graft Versus Host Disease

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