Conversion of CellCept to Myfortic: A Prospective Study in Liver Transplant Recipients
This study has been completed.
Information provided by (Responsible Party):
Roberto Lopez, MD, University of Pittsburgh
First received: June 12, 2006
Last updated: November 3, 2016
Last verified: November 2016
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.
||Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
||Conversion of CellCept to Myfortic: A Prospective Study on the Tolerability and Safety of Myfortic in Liver Transplant Recipients
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.
| Study Start Date:
| Study Completion Date:
| Primary Completion Date:
||November 2008 (Final data collection date for primary outcome measure)
Experimental: Liver Transplant Subjects
All subjects in this study will receive Myfortic 360mg or 720 mg BID for 90 days.
Myfortic 360mg or 720 mg BID for 90 days.
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.
|Ages Eligible for Study:
||18 Years to 80 Years (Adult, Senior)
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- 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
- 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
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00336895
|University of Pittsburgh Medical Center
|Pittsburgh, Pennsylvania, United States, 15213 |
University of Pittsburgh
||Michael E de Vera, MD
||University of Pittsburgh
||Roberto Lopez, MD, Assistant Professor of Surgery, University of Pittsburgh
History of Changes
|Other Study ID Numbers:
|Study First Received:
||June 12, 2006
|Results First Received:
||May 19, 2016
||November 3, 2016
||United States: Institutional Review Board
Keywords provided by University of Pittsburgh:
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on December 02, 2016
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs