Budesonide for Prevention of Acute Gastrointestinal GVHD Following Allogenic Stem Cell Transplantation

Phase 3 Completed 242 enrolled Technical University Dresden Dr. Falk Pharma GmbH · collab

RandomizedParallel-groupDouble-blindPrevention

Summary

The purpose of this study is to determine whether orale budesonide is effective in the prevention of acute gastrointestinal graft-versus-host disease (GVHD) following allogenic stem cell transplantation.

Timeline

Start: 2004-01
Primary completion: 2009-03
Completion: 2010-01

Outcome

Missed primary endpoint

paper 12.5% (95% CI 3-22%) under treatment with budesonide and 14% (95% CI 4-25%) under placebo (p = 0.888). PMID 25425214 ↗

paper Budesonide did not decrease the occurrence of intestinal GvHD in this trial. PMID 25425214 ↗

Publications

Schmelz R, Bornhauser M, Schetelig J, Kiani A, Platzbecker U, Schwanebeck U, Grahlert X, Uharek L, Aust D, Baretton G, Schwerdtfeger R, Hampe J, Greinwald R, Mueller R, Ehninger G, Miehlke S. Randomised, double-blind, placebo-controlled trial of oral budesonide for prophylaxis of acute intestinal graft-versus-host disease after allogeneic stem cell transplantation (PROGAST). BMC Gastroenterol. 2014 Nov 26;14:197. doi: 10.1186/s12876-014-0197-7.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Budesonide	Small molecule	—	Oral