Trial information
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 type: Interventional; Treatment; Non-Randomized; Open Label; Uncontrolled; Single Group; Safety/Efficacy study
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:
- adult patients, >=18 years of age;
- patients receiving their first heart transplant (single organ transplant).
Exclusion criteria:
- patients with a positive donor-specific cross-match at the time of transplantation;
- patients with any antibody-treated acute rejection;
- known contraindications to treatment with sirolimus;
- history of malignancy, other than excised non-melanoma skin cancer which has not recurred for 2 years.
Gender: Males or Females
Age limits: Min: 18 Years Max: N/A (No limit)
Accepts healthy volunteers: No
Anticipated start date: August, 2006
Trial registration date: 07/19/2006
Date last updated: 11/21/2008
Link to trial result
This trial was conducted at the following locations:
China
