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