Conversion of CellCept to Myfortic: A Prospective Study in Liver Transplant Recipients

University of Pittsburgh

Status

Completed

Conditions

Immunosuppression

Treatments

Drug: Myfortic

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT00336895

CERL080A-US27

Details and patient eligibility

About

The objective of this study is to determine the tolerability and safety of Myfortic in liver transplant patients. Patients receiving CellCept who have GI side effects will have CellCept discontinued and changed to Myfortic (Myfortic is a new drug similar to CellCept, except it is enteric-coated). Our hypothesis is that Myfortic has less GI side effects and will, therefore, be tolerated better than CellCept and also that Myfortic will have a comparable effectiveness to CellCept.

Full description

This is a prospective, single center, open-label, safety and tolerability study on the use of Myfortic after liver transplantation. Adult liver transplant patients who are experiencing GI symptoms (nausea, vomiting, diarrhea, abdominal discomfort/pain, dyspepsia) attributable to CellCept are eligible to enter the study. CellCept will be discontinued and replaced with Myfortic. The duration of the study will be 3 months, and during this time, we will assess the incidence and severity of GI adverse events, the incidence and severity of bone marrow suppression (leukopenia), and the incidence of cytomegalovirus (CMV) infection or disease in patients receiving Myfortic.

Enrollment

29 patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

ALL patients will be adult liver transplant recipients, males or females, 18-80 years of age
Patients currently receiving tacrolimus or cyclosporine with or without corticosteroids as part of their immunosuppressive regimen
Patients must be receiving CellCept and must have attributable G.I. symptoms (nausea, vomiting, diarrhea, abdominal discomfort/pain, dyspepsia)
Patients must be more than 30 days post-transplant to be eligible
Females of childbearing potential must have a negative serum pregnancy test prior to the inclusion period

Exclusion criteria

Multi-organ transplant patients
HIV positive patients.
Living-related liver transplant recipients
Pregnant patients
Patients with a history of extra-hepatic malignancy within the last five years, except excised squamous or basal cell carcinoma of the skin
Patients with thrombocytopenia (<50,000/mm3), with an absolute neutrophil count of <1,000/mm3 and/or leukocytopenia (<2,000/mm3), and/or hemoglobin <7.0 g/dL prior to enrollment
Patients with a G.I. clinical problem at the time of enrollment (e.g. CMV infection or disease, C. difficile colitis, active peptic ulcer disease, gastroenteritis, inflammatory bowel disease)
Presence of clinically significant infection requiring continued therapy or uncontrolled diabetes mellitus
Evidence of drug and/or alcohol abuse
Decisionally impaired subjects who are not medically or mentally capable of providing consent themselves