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

This study has been completed.
Sponsor:
Collaborator:
Novartis Pharmaceuticals
Information provided by (Responsible Party):
Roberto Lopez, MD, University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT00336895
First received: June 12, 2006
Last updated: November 3, 2016
Last verified: November 2016
  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

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Conversion of CellCept to Myfortic: A Prospective Study on the Tolerability and Safety of Myfortic in Liver Transplant Recipients

Resource links provided by NLM:


Further study details as provided by University of Pittsburgh:

Primary Outcome Measures:
  • Gastrointestinal Side Effects and Quality of Life (Total Score of GSRS) [ Time Frame: screening, 2, 6 and 12 weeks ] [ Designated as safety issue: No ]

    The gastrointestinal Symptom Rating Scale (GSRS) is a validated scale, the items range from 1= No discomfort at all to 7= Very severe discomfort.

    The scale ranges from a minimal value of 15 ( No discomfort at all) to a maximum of 105 ( Very severe discomfort)

    The GSRS contains 15 items, each rated on a seven- point likert scale from no discomfort to very severe discomfort. Based on a factor analysis, the 15 GSRS items breakdown into the following five scales: abdominal ( Abdominal pain, hunger pains and nausea): reflux syndrome (heartburn and acid regurgitation), diarrhea syndrome (diarrhea, loose stools and urgent need for defecation), indigestion syndrome ( borborygmus, abdominal distention, eructation and increased flatus) and constipation syndrome (constipation, hard stools and feeling of incomplete evacuation)


  • Number of Participants With Cytomegalovirus Infection or Disease [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Gastrointestinal Side Effects and Quality of Life (-Subscales of GSRS) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

    The GSRS contains 15 items, each rated on a seven- point likert scale from no discomfort to very severe discomfort. Based on a factor analysis, the 15 GSRS items breakdown into the following five scales: abdominal ( Abdominal pain, hunger pains and nausea): reflux syndrome (heartburn and acid regurgitation), diarrhea syndrome (diarrhea, loose stools and urgent need for defecation), indigestion syndrome ( borborygmus, abdominal distention, eructation and increased flatus) and constipation syndrome (constipation, hard stools and feeling of incomplete evacuation) The range of the scale for abdominal pain was 3 to 21, reflux 2 to 14, diarrhea 3 to 21, indigestion 4 to 28 and constipation 3 to 21.

    Higher values represent more severe discomfort.



Enrollment: 29
Study Start Date: November 2006
Study Completion Date: November 2008
Primary Completion Date: November 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Liver Transplant Subjects
All subjects in this study will receive Myfortic 360mg or 720 mg BID for 90 days.
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   (Adult, Senior)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
United States, Pennsylvania
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States, 15213
Sponsors and Collaborators
University of Pittsburgh
Novartis Pharmaceuticals
Investigators
Principal Investigator: Michael E de Vera, MD University of Pittsburgh
  More Information

Responsible Party: Roberto Lopez, MD, Assistant Professor of Surgery, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT00336895     History of Changes
Other Study ID Numbers: CERL080A-US27 
Study First Received: June 12, 2006
Results First Received: May 19, 2016
Last Updated: November 3, 2016
Health Authority: United States: Institutional Review Board

Keywords provided by University of Pittsburgh:
Liver transplantation
mycophenolate mofetil
gastrointestinal
adverse effects

Additional relevant MeSH terms:
Mycophenolate mofetil
Mycophenolic Acid
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antibiotics, Antineoplastic
Antineoplastic Agents

ClinicalTrials.gov processed this record on December 02, 2016