Trial Information

Summary: A Study of CellCept (Mycophenolate Mofetil) in Combination Therapy in Liver Transplant Patients.

Status: Recruiting

Protocol Number: ML21273

Sponsor: Hoffmann-La Roche

Company Division: Pharmaceutical

Official Scientific Title: A randomized, open label study comparing the effect of CellCept with therapeutic drug monitoring, tacrolimus and a corticosteroid-sparing regimen versus fixed dose CellCept, tacrolimus and corticosteroids maintained up to 6 months, on acute rejection and safety in liver transplant patients.

Brief Summary: This 2 arm study will compare the efficacy and safety of two CellCept-containing treatment regimens in de novo liver transplant patients. Patients will be randomized into one of two groups, to receive either CellCept (at a starting dose of 3g/day po, adjusted according to exposure) standard dose tacrolimus and corticosteroids (10-15 mg/kg i.v. on day 0), or fixed dose CellCept 2g/day po, standard dose tacrolimus and corticosteroids (10-15mg/kg i.v. on day 0, then reducing from 20mg to 5mg over 6 months, and discontinuing after 6 months). The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals. Target sample size is 250.

Study Phase: IV

Study Design / Study Details:

• Purpose: Treatment
• Allocation: Randomized
• Masking: Open Label
• Control: Active
• Assignment: Parallel
• Endpoints: Safety/Efficacy

Study Type:

Condition: Liver Transplantation

Intervention Type: Drug

Intervention Name: mycophenolate mofetil [CellCept]

Primary Outcome: 1. Incidence of biopsy-proven and treated acute rejection Time frame: Up to month 12

Key Secondary Outcomes: 1. Patient and graft survival; histological evaluation of grafts. Time frame: Month 12 2. Cardiovascular outcomes and renal function Time frame: Month 12 3. AEs, laboratory parameters. Time frame: Throughout study

Inclusion Criteria:

Exclusion Criteria:

Gender: Males or Females

Age Limits: Min: 18 Years

Accepts Healthy Volunteers: No

Anticipated Start Date: October, 2007

Trial Registration Date: 10/15/2007

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 2:16:19 PM