Budesonide for Prevention of Acute Gastrointestinal GVHD Following Allogenic Stem Cell Transplantation
Efficacy and Safety of Orale Budesonide in the Prevention of Acute Gastrointestinal Graft-versus-host Disease Following Allogenic Stem Cell Transplantation
1 other identifier
interventional
242
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3 leukemia
Started Jan 2004
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2004
CompletedFirst Submitted
Initial submission to the registry
September 9, 2005
CompletedFirst Posted
Study publicly available on registry
September 16, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2010
CompletedMarch 30, 2010
March 1, 2010
5.2 years
September 9, 2005
March 29, 2010
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
incidence of acute gastrointestinal (GI) GVHD in the active group versus placebo group
Secondary Outcomes (5)
safety
grade of acute GI GVHD
incidence of chronic GI GVHD
incidence of infectious complications
overall and disease-free survival 1 yr after transplant
Interventions
Eligibility Criteria
You may qualify if:
- planned allogenic stem cell or bone marrow transplantation
- HLA identity (max. 1 mismatch)
- standard GVHD prophylaxis with cyclosporin A or tacrolimus combined with MTX, +/- ATG or Campath1H
- written informed consent
You may not qualify if:
- history of allogenic transplantation
- in vitro T-cell depleted transplant
- pretreatment with budesonide within the previous 4 weeks
- known intolerance to budesonide
- gastrointestinal infections
- portal hypertension
- concomitant infectious diseases
- liver cirrhosis, impaired liver function
- severe mental disorder
- lack of compliance
- drug or alcohol abuse
- pregnancy, lactation
- childbearing potential without effective contraception
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Technische Universität Dresdenlead
- Dr. Falk Pharma GmbHcollaborator
Study Sites (1)
Medical Department I, Technical University Hospital
Dresden, 01307, Germany
Related Publications (1)
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.
PMID: 25425214DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Stephan Miehlke, Prof.
Medical Department I, Technical University Hospital, Dresden, Germany
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
September 9, 2005
First Posted
September 16, 2005
Study Start
January 1, 2004
Primary Completion
March 1, 2009
Study Completion
January 1, 2010
Last Updated
March 30, 2010
Record last verified: 2010-03