Treatment of Gastro-Intestinal and/or Hepatic Graft Versus Host Disease With Budesonide in Patients Following Peripheral Blood Stem Cell Transplantation
This study has been completed.
Sponsor:
Rafa Laboratories
Collaborator:
Dr. Falk Pharma GmbH
Information provided by:
Rafa Laboratories
ClinicalTrials.gov Identifier:
NCT00128739
First received: August 9, 2005
Last updated: August 26, 2005
Last verified: August 2005
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Purpose
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 Patients with Grades 3 or 4 will be withdrawn from the study if there is no response after one week of therapy.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 | Intervention | Phase |
|---|---|---|
|
Graft Vs Host Disease |
Drug: Budesonide |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Double-Blind Primary Purpose: Treatment |
| Official Title: | A Phase 3 Study to Evaluate the Place of Budesonide in the Treatment of GVHD |
Resource links provided by NLM:
Further study details as provided by Rafa Laboratories:
| Estimated Enrollment: | 24 |
| Study Start Date: | January 2001 |
| Estimated Study Completion Date: | August 2005 |
Show Detailed Description Eligibility| Ages Eligible for Study: | 18 Years to 70 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00128739
Locations
| Israel | |
| Hadassah Medical Organization, | |
| Jerusalem, Israel, 91120 | |
Sponsors and Collaborators
Rafa Laboratories
Dr. Falk Pharma GmbH
Investigators
| Principal Investigator: | Michael Y Shapira, MD | Hadassah Medical Organization |
More Information
No publications provided
| ClinicalTrials.gov Identifier: | NCT00128739 History of Changes |
| Other Study ID Numbers: | 25-23/02/01 |
| Study First Received: | August 9, 2005 |
| Last Updated: | August 26, 2005 |
| Health Authority: | Israel: Israeli Health Ministry Pharmaceutical Administration |
Additional relevant MeSH terms:
|
Graft vs Host Disease Immune System Diseases Budesonide Bronchodilator Agents Autonomic Agents Peripheral Nervous System Agents Physiological Effects of Drugs Pharmacologic Actions |
Anti-Asthmatic Agents Respiratory System Agents Therapeutic Uses Glucocorticoids Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Anti-Inflammatory Agents |
ClinicalTrials.gov processed this record on May 23, 2013