Immunosuppression | Conversion of CellCept to Myfortic: A Prospective Study in Liver Transplant Recipients
Immunosuppression research study
What is the primary objective of this study?
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.
Who is eligible to participate?
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
Which medical condition, disease, disorder, syndrome, illness, or injury is researched?
Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.
Drug:MyforticMyfortic 360mg or 720 mg BID for 90 days.
Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.
Liver Transplant SubjectsAll subjects in this study will receive Myfortic 360mg or 720 mg BID for 90 days.
Start Date: November 2006
Completed Date: November 2008
Primary Outcome: Gastrointestinal Side Effects and Quality of Life (Total Score of GSRS)
Study sponsors, principal investigator, and references
Principal Investigator: Michael E de Vera, MD
Lead Sponsor: University of Pittsburgh
Collaborator: Novartis Pharmaceuticals