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

This study is currently recruiting participants.
Verified by University of Pittsburgh, February 2008

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   

ChemIDplus related topics:   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:
    Drug: Myfortic
    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: Amadeo Marcos, MD            
      Sub-Investigator: J. Wallis Marsh, MD`            
      Sub-Investigator: Paulo Fontes, MD            
      Sub-Investigator: Kusum Tom, MD            
      Sub-Investigator: Kyle Soltys, MD            
      Sub-Investigator: Ngoc Thai, MD            
      Sub-Investigator: Roberto Lopez, MD            
      Sub-Investigator: Deanna Blisard, MD            
      Sub-Investigator: Vinay Kumaran, MD            
      Sub-Investigator: Liise Kayler, 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
First Received:   June 12, 2006
Last Updated:   March 3, 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 September 25, 2008




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