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

Phase 3CompletedNCT02091414

Hoffmann-La Roche36 enrolled

Overview

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 24 weeks.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Heart Transplantation

Interventions

mycophenolate mofetil (MMF)DRUG

1.0 g PO BID

cyclosporine A (CsA)DRUG

Initial loading dose of 4 to 6 mg/kg within 48 hours of transplantation, adjusted thereafter to a blood trough concentration of 150 to 300 ng/mL

corticosteroidsDRUG

As per the practice of each participating center

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (3)

Unnamed facility

Beijing, China

Unnamed facility

Fuzhou, China

Unnamed facility

Shanghai, China

Outcomes

Primary Outcomes

Percentage of Participants With Biopsy Proven Acute Rejection (BPAR) by Week

Percentage of participants with BPAR of greater than or equal to (≥) International Society of Heart and Lung Transplant (ISHLT) Grade III. The ISHLT graded symptoms on a scale of Grade 0 through VI. Grade 0 equals (=) no rejection. Grade IA = regional (perivascular or interstitial) infiltration and no necrosis, and grade IB = dissemination but little infiltration and no necrosis. Grade II = 1 focus of invasive infiltration with or without (+/-) associated cardiomyocyte necrosis. Grade IIIA = 2 or more foci of invasive infiltration +/- associated cardiomyocyte necrosis, and grade IIIB = diffuse inflammatory pathological changes associated with cardiomyocyte necrosis. Grade IV = diffuse, infiltrative multi-foci +/- edema; +/- hemorrhage; and +/-vasculitis.