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.

First Received: August 9, 2005 Last Updated: August 26, 2005 History of Changes

Sponsor:	Rafa Laboratories
Collaborator:	Dr. Falk Pharma GmbH
Information provided by:	Rafa Laboratories
ClinicalTrials.gov Identifier:	NCT00128739

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 Patients with Grades 3 or 4 will be withdrawn from the study if there is no response after one week of therapy.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

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Single Group Assignment, Efficacy Study
Official Title:	A Phase 3 Study to Evaluate the Place of Budesonide in the Treatment of GVHD

Resource links provided by NLM:

Drug Information available for: Budesonide

U.S. FDA Resources

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, Jerusalem, Israel

More Information

No publications provided

Study ID Numbers:	25-23/02/01
Study First Received:	August 9, 2005
Last Updated:	August 26, 2005
ClinicalTrials.gov Identifier:	NCT00128739 History of Changes
Health Authority:	Israel: Israeli Health Ministry Pharmaceutical Administration

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Respiratory System Agents
Immune System Diseases
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Budesonide
Anti-Asthmatic Agents
Glucocorticoids

Hormones
Pharmacologic Actions
Autonomic Agents
Therapeutic Uses
Graft vs Host Disease
Peripheral Nervous System Agents
Bronchodilator Agents

ClinicalTrials.gov processed this record on February 08, 2010