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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00336895
Recruitment Status : Completed
First Posted : June 14, 2006
Results First Posted : November 6, 2016
Last Update Posted : November 6, 2016
Sponsor:
Collaborator:
Novartis Pharmaceuticals
Information provided by (Responsible Party):
Roberto Lopez, MD, University of Pittsburgh

Study Description
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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.

Condition or disease Intervention/treatment Phase
Immunosuppression Drug: Myfortic Not Applicable

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 29 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : November 2006
Actual Primary Completion Date : November 2008
Actual Study Completion Date : November 2008

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Arms and Interventions
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Arm Intervention/treatment
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.


Outcome Measures
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Primary Outcome Measures :
  1. Gastrointestinal Side Effects and Quality of Life (Total Score of GSRS) [ Time Frame: screening, 2, 6 and 12 weeks ]

    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)


  2. Number of Participants With Cytomegalovirus Infection or Disease [ Time Frame: 12 weeks ]
  3. Gastrointestinal Side Effects and Quality of Life (-Subscales of GSRS) [ Time Frame: 12 weeks ]

    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.



Eligibility Criteria
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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00336895


Locations
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United States, Pennsylvania
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States, 15213
Sponsors and Collaborators
University of Pittsburgh
Novartis Pharmaceuticals
Investigators
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Principal Investigator: Michael E de Vera, MD University of Pittsburgh Medical Center
More Information
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Responsible Party: Roberto Lopez, MD, Assistant Professor of Surgery, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT00336895    
Other Study ID Numbers: CERL080A-US27
First Posted: June 14, 2006    Key Record Dates
Results First Posted: November 6, 2016
Last Update Posted: November 6, 2016
Last Verified: November 2016
Keywords provided by Roberto Lopez, MD, University of Pittsburgh:
Liver transplantation
mycophenolate mofetil
gastrointestinal
adverse effects
Additional relevant MeSH terms:
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Mycophenolic Acid
Antibiotics, Antineoplastic
Antineoplastic Agents
Antibiotics, Antitubercular
Antitubercular Agents
 Anti-Bacterial Agents
Anti-Infective Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action