Clinical Trial VICCBMT1381

Title

A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study of the Safety and Efficacy of Orbec? (Oral Beclomethasone 17,21-Dipropionate) Administered as Monotherapy in the Treatment of Upper Gastrointestinal (GI) Symptoms Caused by Graft vs Host Disease (GVHD) in Patients with Chronic GI GVHD

Principal Investigator(s)

Bipin Savani

Details

  • Protocol No. VICCBMT1381
  • Open Date: 01/23/2014
  • Staging: Phase II
  • Age Group: Adults
  • Scope: National
  • Objective: The primary efficacy objective of this study is to estimate the proportion of subjects who achieve a complete response (CR), partial response (PR) and overall response (OR) of gastrointestinal graft versus host disease (GI GVHD) signs and symptoms when treated with oral BDP, 2 mg q.i.d. (8 mg/day) versus placebo, for up to 16 weeks, in patients with chronic GVHD (cGVHD).
  • Disease Sites: Gastrointestinal; Pancreatic; Esophageal; Colon
  • Therapies: Molecular Targeted Agents / Immunotherapy / Biologics
  • Drugs: orBec
  • Participating Institutions: Vanderbilt University
  • National Clinical Trial ID: NCT01925950
  • Secondary Protocol No: BDP-GVHD-08

Description

Eligibility

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