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

NCT00128739 | Completed Phase 3

• 1 other identifier: 25-23/02/01
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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 Patients with Grades 3 or 4 will be withdrawn from the study if there is no response after one week of therapy.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.

Conditions

Graft Vs Host Disease

Interventions

Budesonide DRUG

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Rafa Laboratories: lead
• Dr. Falk Pharma GmbH: collaborator

Study Sites (1)

Hadassah Medical Organization,

Jerusalem, 91120, Israel

Location

MeSH Terms

Conditions

Graft vs Host Disease

Interventions

Budesonide

Condition Hierarchy (Ancestors)

Immune System Diseases

Intervention Hierarchy (Ancestors)

Pregnenediones; Pregnenes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• Michael Y Shapira, MD

  Hadassah Medical Organization

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: August 9, 2005
• First Posted: August 10, 2005
• Study Start: January 1, 2001
• Study Completion: August 1, 2005
• Last Updated: August 29, 2005

Record last verified: 2005-08

Locations

IL (1)