Trial Information

Summary: A Study of CellCept (Mycophenolate Mofetil) in Heart Transplant Patients.

Status: Completed

Protocol Number: M55021

Sponsor: F. Hoffmann-La Roche Ltd

Company Division: Pharmaceutical

Official Scientific Title: A randomized, open-label study to evaluate pharmacokinetic variability of CellCept in association with cyclosporine and corticosteroids in primary orthotopic heart transplant patients

Brief Summary: This study will evaluate the pharmacokinetic variability (in terms of AUC) of CellCept in association with cyclosporine and corticosteroids, in primary orthotopic heart transplant patients. Within 72 hours of transplantation, patients will be randomized to one of 2 groups; one group will remain on a fixed dose of CellCept for 3 months, and the other will have their dose adjusted in order to maintain an AUC of mycophenolate mofetil within a target range. CellCept treatment (plus cyclosporine and corticosteroids) will continue for a further 9 months. The anticipated time on study treatment is 3-12 months, and the target sample size is < 100 individuals. Target sample size is 50.

Study Phase: II

Study Design / Study Details:

• Purpose: Treatment
• Allocation: Randomized
• Masking: Open Label
• Control:
• Assignment: Parallel
• Endpoints: Pharmacokinetics

Study Type:

Condition: Heart Transplantation

Intervention Type: Drug

Intervention Name: mycophenolate mofetil[CellCept]

Primary Outcome: 1. Pharmacokinetics:AUC 0-12 of mycophenolic acid. Efficacy: Acute rejection rate; allograft artery disease incidence; overall survival.

Key Secondary Outcomes: 1. Safety: AEs; opportunistic infection; malignancy.

Inclusion Criteria:

Exclusion Criteria:

Gender: Males or Females

Age Limits: Min: 18 Years Max: 65 Years

Accepts Healthy Volunteers: No

Trial Registration Date: 06/16/2006

Date Last Updated: 08/18/2008

Link To Trial Results

This site is run by CenterWatch, a publishing company that focuses on the clinical trials industry. The information provided in this service is designed to help patients find clinical trials that may be of interest to them, and to help patients contact the centers conducting the research. CenterWatch is neither promoting this research nor involved in conducting any of these trials.

Trial listings updated: August 20, 2008 at 2:21:25 PM