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

This study has been completed.
Sponsor:
Collaborator:
Dr. Falk Pharma GmbH
Information provided by:
Dresden University of Technology
ClinicalTrials.gov Identifier:
NCT00180089
First received: September 9, 2005
Last updated: March 29, 2010
Last verified: March 2010
History of Changes

September 9, 2005
March 29, 2010
January 2004
March 2009   (final data collection date for primary outcome measure)
incidence of acute gastrointestinal (GI) GVHD in the active group versus placebo group
Same as current
Complete list of historical versions of study NCT00180089 on ClinicalTrials.gov Archive Site
  • safety
  • grade of acute GI GVHD
  • incidence of chronic GI GVHD
  • incidence of infectious complications
  • overall and disease-free survival 1 yr after transplant
Same as current
Not Provided
Not Provided
 
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

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.

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.
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Prevention
  • Leukemia
  • Graft-Versus-Host Disease
Drug: Budesonide
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
242
January 2010
March 2009   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
Both
12 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT00180089
PROGAST
Not Provided
Not Provided
Dresden University of Technology
Dr. Falk Pharma GmbH
Principal Investigator: Stephan Miehlke, Prof. Medical Department I, Technical University Hospital, Dresden, Germany
Dresden University of Technology
March 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP