Status:
COMPLETED
Treatment of Gastro-Intestinal and/or Hepatic Graft Versus Host Disease With Budesonide in Patients Following Peripheral Blood Stem Cell Transplantation
Lead Sponsor:
Rafa Laboratories
Collaborating Sponsors:
Dr. Falk Pharma GmbH
Conditions:
Graft Vs Host Disease
Eligibility:
All Genders
18-70 years
Phase:
PHASE3
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 ...
Detailed Description
Graft versus host disease (GVHD) is one of the most common complications of bone marrow transplantation (BMT). Targets of GVHD are the gastro-intestinal tract (GIT) liver and skin, causing severe diar...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
January 1 2001
Trial Type :
INTERVENTIONAL
End Date :
August 1 2005
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT00128739
Start Date
January 1 2001
End Date
August 1 2005
Last Update
August 29 2005
Active Locations (1)
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1
Hadassah Medical Organization,
Jerusalem, Israel, 91120