- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00336895
Conversion of CellCept to Myfortic: A Prospective Study in Liver Transplant Recipients
Conversion of CellCept to Myfortic: A Prospective Study on the Tolerability and Safety of Myfortic in Liver Transplant Recipients
Study Overview
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Pennsylvania
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Pittsburgh, Pennsylvania, United States, 15213
- University of Pittsburgh Medical Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Liver Transplant Subjects
All subjects in this study will receive Myfortic 360mg or 720 mg BID for 90 days.
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Myfortic 360mg or 720 mg BID for 90 days.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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) |
screening, 2, 6 and 12 weeks
|
Number of Participants With Cytomegalovirus Infection or Disease
Time Frame: 12 weeks
|
12 weeks
|
|
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. |
12 weeks
|
Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CERL080A-US27
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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