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Treatment of Gastro-Intestinal and/or Hepatic Graft Versus Host Disease With Budesonide in Patients Following Peripheral Blood Stem Cell Transplantation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00128739
Recruitment Status : Completed
First Posted : August 10, 2005
Last Update Posted : August 29, 2005
Dr. Falk Pharma GmbH
Information provided by:
Rafa Laboratories

Brief Summary:
Twenty-four (2 x 12) patients with intestinal graft versus host disease (GVHD) Grades 2, 3 or 4 will be treated with budesonide 3mg three times daily or placebo for 12 weeks. All of the patients will receive cyclosporine and by mouth (po) prednisone or intravenous (IV) methylprednisone with a starting dose of 2mg/kg/day (standard anti-GVHD treatment). Doses of steroids will be decreased by approximately 10% or 10mg per week (depending upon patient's weight) upon response to therapy, defined as a decrease of volume of diarrhea by 50% per day, decrease in abdominal pain and no presence of bloody stool. Patients with Grades 3 or 4 will be withdrawn from the study if there is no response after one week of therapy. Patients with Grade 2 may continue with no decrease in prednisone dose until response is achieved.

Condition or disease Intervention/treatment Phase
Graft Vs Host Disease Drug: Budesonide Phase 3

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Study Type : Interventional  (Clinical Trial)
Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: A Phase 3 Study to Evaluate the Place of Budesonide in the Treatment of GVHD
Study Start Date : January 2001
Study Completion Date : August 2005

Resource links provided by the National Library of Medicine

Drug Information available for: Budesonide

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Patients with clinical and biopsy proven Grades 2, 3 or 4 intestinal GVHD
  • Patients with a negative stool culture
  • Male or female patients aged between 18 - 70 years
  • Signed written informed consent of the patient

Exclusion Criteria:

  • Uncertain GVHD diagnosis (other causes of intestinal disease are possible)
  • Severe other disease which may influence the patient prognosis
  • Contraindication to the use of steroids
  • Patient's inability to swallow the study medications
  • Concurrent use of non-steroidal anti-inflammatory drug (NSAID)
  • Known spontaneous or iatrogenic disturbances of thrombocyte aggregation or blood clotting.
  • Kidney dysfunction with creatinine level higher than 2mg/dl
  • Patients on preventative antimicrobial therapy with the exception of Resprim® (sulfamethoxazole and trimethoprim)
  • Patients taking somatostatin
  • Patients taking anti-GVHD medication with the exception of steroids (maximum dose of prednisone or methylprednisolone 2mg/kg/day) and cyclosporine A or tacrolimus
  • Pregnancy or lactation
  • Insufficient contraception protection
  • Participation in another clinical study within the last 30 days.
  • Mental condition rendering the patient unable to understand the nature or scope and possible consequences of the study and/or evidence of an uncooperative attitude.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00128739

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Hadassah Medical Organization,
Jerusalem, Israel, 91120
Sponsors and Collaborators
Rafa Laboratories
Dr. Falk Pharma GmbH
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Principal Investigator: Michael Y Shapira, MD Hadassah Medical Organization
Layout table for additonal information Identifier: NCT00128739    
Other Study ID Numbers: 25-23/02/01
First Posted: August 10, 2005    Key Record Dates
Last Update Posted: August 29, 2005
Last Verified: August 2005
Additional relevant MeSH terms:
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Graft vs Host Disease
Immune System Diseases
Anti-Inflammatory Agents
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Hormones, Hormone Substitutes, and Hormone Antagonists