Conversion of CellCept to Myfortic: A Prospective Study in Liver Transplant Recipients - Full Text View

Sponsors and Collaborators:	University of Pittsburgh Novartis
Information provided by:	University of Pittsburgh
ClinicalTrials.gov Identifier:	NCT00336895

Purpose

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.

Condition	Intervention
Immunosuppression	Drug: Myfortic

MedlinePlus related topics: Liver Transplantation

Drug Information available for: Mycophenolate Mofetil Mycophenolate mofetil hydrochloride Mycophenolic acid

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety Study
Official Title:	Conversion of CellCept to Myfortic: A Prospective Study on the Tolerability and Safety of Myfortic in Liver Transplant Recipients

Further study details as provided by University of Pittsburgh:

Primary Outcome Measures:

Incidence and severity of GI adverse events [ Time Frame: 2, 6 and 12 weeks ] [ Designated as safety issue: Yes ]
incidence and severity of bone marrow suppression (leukopenia) [ Time Frame: 2, 6 and 12 weeks ] [ Designated as safety issue: Yes ]
incidence of cytomegalovirus infection or disease [ Time Frame: 2, 6 and 12 weeks ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	30
Study Start Date:	November 2006
Estimated Study Completion Date:	November 2008
Estimated Primary Completion Date:	November 2008 (Final data collection date for primary outcome measure)

Intervention Details:

Myfortic 360mg or 720 mg BID for 90 days.

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.

Eligibility

Ages Eligible for Study:	18 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00336895

Contacts

Contact: Michael E de Vera, MD	412-647-5174	deverame@upmc.edu
Contact: Laurie K Hope, RN	412-692-2208	hopelk@upmc.edu

Locations

United States, Pennsylvania
University of Pittsburgh Medical Center	Recruiting
Pittsburgh, Pennsylvania, United States, 15213
Contact: Michael E de Vera, MD 412-647-5174 deverame@upmc.edu
Contact: Laurie K Hope, RN 412-692-2208 hopelk@upmc.edu
Principal Investigator: Michael E de Vera, MD
Sub-Investigator: J. Wallis Marsh, MD`
Sub-Investigator: Paulo Fontes, MD
Sub-Investigator: Kyle Soltys, MD
Sub-Investigator: Roberto Lopez, MD
Sub-Investigator: Deanna Blisard, MD
Sub-Investigator: Vinay Kumaran, MD
Sub-Investigator: Igor Dvorchik, MD
Sub-Investigator: Raman Venkataramanan, MD
Sub-Investigator: Barbara Yelochan, MD

Sponsors and Collaborators

University of Pittsburgh

Novartis

Investigators

Principal Investigator:

Michael E de Vera, MD

University of Pittsburgh

More Information

Responsible Party:	UPMC ( Michael de Vera, M.D. )
Study ID Numbers:	CERL080A-US27
Study First Received:	June 12, 2006
Last Updated:	October 2, 2008
ClinicalTrials.gov Identifier:	NCT00336895
Health Authority:	United States: Institutional Review Board

Keywords provided by University of Pittsburgh:

Liver transplantation
mycophenolate mofetil
gastrointestinal
adverse effects

Study placed in the following topic categories:

Mycophenolate mofetil
Mycophenolic Acid

Additional relevant MeSH terms:

Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Therapeutic Uses

Enzyme Inhibitors
Antibiotics, Antineoplastic
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009