Clinical trial NCT00336895: Conversion of CellCept to Myfortic: A Prospective Study in Liver Transplant Recipients
Official title: Conversion of CellCept to Myfortic: A Prospective Study on the Tolerability and Safety of Myfortic in Liver Transplant Recipients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Immunosuppression
Keywords: Liver transplantation
mycophenolate mofetil
gastrointestinal
adverse effects
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
Collaborators: name: Novartis Pharmaceuticals
First posted: 2006-06-14
Enrollment: 29
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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 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

Primary outcomes:
measure: Gastrointestinal Side Effects and Quality of Life (Total Score of GSRS)
timeFrame: screening, 2, 6 and 12 weeks
measure: Number of Participants With Cytomegalovirus Infection or Disease
timeFrame: 12 weeks
measure: Gastrointestinal Side Effects and Quality of Life (-Subscales of GSRS)
timeFrame: 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: University of Pittsburgh Medical Center
state: Pennsylvania
Study officials:
affiliation: University of Pittsburgh Medical Center
name: Michael E de Vera, MD
role: PRINCIPAL_INVESTIGATOR
References: