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

NCT ID: NCT00336895

Last Updated: 2016-11-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 29 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-11-30
• Study Completion Date: 2008-11-30

Brief Summary

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.

Detailed 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.

Conditions

Immunosuppression

Keywords

Liver transplantation; mycophenolate mofetil; gastrointestinal; adverse effects

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Liver Transplant Subjects

All subjects in this study will receive Myfortic 360mg or 720 mg BID for 90 days.

Group Type: EXPERIMENTAL

Myfortic

Intervention Type: DRUG

Myfortic 360mg or 720 mg BID for 90 days.

Interventions

Myfortic

Myfortic 360mg or 720 mg BID for 90 days.

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Novartis Pharmaceuticals

INDUSTRY

Sponsor Role: collaborator

University of Pittsburgh

OTHER

Sponsor Role: lead

Responsible Party

Roberto Lopez, MD

Assistant Professor of Surgery

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Michael E de Vera, MD

Role: PRINCIPAL_INVESTIGATOR

University of Pittsburgh Medical Center

Locations

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, United States

Countries

United States

Other Identifiers

CERL080A-US27

Identifier Type: -

Identifier Source: org_study_id