Trial Information

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

Status: Completed

Protocol Number: PA16522

Sponsor: Roche Global Development

Company Division: Pharmaceutical

Official Scientific Title: A randomized, open-label study of the effect of CellCept on the pharmacokinetics of tacrolimus and clinical outcome in liver transplant patients

Brief Summary: This study will evaluate the pharmacokinetics, efficacy and safety of CellCept in liver transplant patients currently receiving tacrolimus. The anticipated time on study treatment is 3-12 months, and the target sample size is <100 individuals. Target sample size is 60.

Study Phase: II

Study Design / Study Details:

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

Study Type:

Interventional

Condition: Liver Transplantation

Intervention Type: Drug

Intervention Name: mycophenolate mofetil[CellCept]

Primary Outcome: 1. Pharmacokinetics: MPA and MPAG plasma and urine concentrations Efficacy: Biopsy-proven acute rejection or graft loss by week 26 post-transplant

Key Secondary Outcomes: 1. Safety: Laboratory safety tests, rejection data, graft and patient survival, AEs Efficacy: Biopsy-proven acute rejection or graft loss by week 52 post-transplant. Time to first biopsy-proven acute rejection

Inclusion Criteria:

  • adult patients >=18 years of age;
  • first orthotopic liver transplant;
  • single organ transplant;
  • patients of child-bearing potential must be willing to use 2 forms of contraception from the beginning of the trial to 6 weeks after completion of dosing.

Exclusion Criteria:

  • previous organ transplant;
  • positive HIV test result;
  • concomitant treatment with another investigational drug or with a prohibited immunosuppressive agent;
  • dialysis within 30 days prior to transplantation;
  • history of malignancy other than adequately-treated skin melanoma.

Gender: Males or Females

Age Limits: Min: 18 Years

Accepts Healthy Volunteers: No

Trial Registration Date: 05/23/2005

Date Last Updated: 08/18/2008

Link To Trial Results

Contact:

Research Site:
Located In:
Hannover, Germany, 30625
Telephone: 973-235-5000 or 800-526-6367

  

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Trial listings updated: August 20, 2008 at 2:15:54 PM


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