N/A
Completed N=30
Conversion of CellCept to Myfortic: A Prospective Study in Liver Transplant Recipients
Source: ClinicalTrials.gov NCT00336895 ↗Enrolled (actual)
30
Serious AEs
0.0%
Results posted
Nov 2016
Primary outcomePrimary: Gastrointestinal Side Effects and Quality of Life (Total Score of GSRS) — 46.000; 29.0400; 26.2800; 25.3600 units on a scale
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Gastrointestinal Side Effects and Quality of Life (Total Score of GSRS) |
46.000; 29.0400; 26.2800; 25.3600 | — |
| PRIMARY Number of Participants With Cytomegalovirus Infection or Disease |
— | — |
| PRIMARY Gastrointestinal Side Effects and Quality of Life (-Subscales of GSRS) |
10.78; 2.64; 7.08; 5.44; 4.56 | — |
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT00336895). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.