Trial Information

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

Status: Completed

Protocol Number: ML20055

Sponsor: Hoffmann-La Roche

Company Division: Pharmaceutical

Official Scientific Title: An open label study to evaluate the effect of CellCept in combination wth cyclosporine A and steroids on renal function and the prevention of acute rejection in heart transplant patients.

Brief Summary: This study will investigate the efficacy and safety of CellCept (1.5-2g/day po), in combination with a standard care regimen of cyclosporine A (trough level 150-200ng/mL) and steroids, in patients receiving a heart transplant. The anticipated time on study treatment is 3-12 months, and the target sample size is <100 individuals. Target sample size is 36.

Study Phase: III

Study Design / Study Details:

• Purpose: Treatment
• Allocation: Non-Randomized
• Masking: Open Label
• Control: Uncontrolled
• Assignment: Single Group
• Endpoints: Safety/Efficacy

Study Type:

Condition: Heart Transplantation

Intervention Type: Drug

Intervention Name: mycophenolate mofetil[CellCept]

Primary Outcome: 1. Renal function (calculated creatinine clearance at 24 weeks post-transplant), incidence of acute rejection or HDC, or graft loss, up to 12 months post-transplant.

Key Secondary Outcomes: 1. Efficacy: incidence of malignancies; incidence of infections; AEs.

Inclusion Criteria:

Exclusion Criteria:

Gender: Males or Females

Age Limits: Min: 18 Years

Accepts Healthy Volunteers: No

Anticipated Start Date: August, 2006

Trial Registration Date: 07/19/2006

Date Last Updated: 09/19/2008

Link To Trial Results

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Trial listings updated: September 22, 2008 at 2:55:28 PM