Phase 4
Completed N=180
A Study of CellCept (Mycophenolate Mofetil) in Combination Therapy in Liver Transplant Patients.
Source: ClinicalTrials.gov NCT00545402 ↗Enrolled (actual)
180
Serious AEs
76.0%
Results posted
Jul 2014
Primary outcomePrimary: Percentage of Participants With Treated Biopsy Proven Acute Rejection (BPAR) According to Banff Criteria up to 12 Months Post-Transplant — 8.0; 8.2 percentage of participants
Summary
This 2 arm study will compare the efficacy and safety of two CellCept-containing treatment regimens in de novo liver transplant patients. Patients will be randomized into one of two groups, to receive either CellCept (at a starting dose of 3g/day po, adjusted according to exposure) standard dose tacrolimus and corticosteroids (10-15 mg/kg i.v. on day 0), or fixed dose CellCept 2g/day po, standard dose tacrolimus and corticosteroids (10-15mg/kg i.v. on day 0, then reducing from 20mg to 5mg over 6 months, and discontinuing after 6 months). The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Treated Biopsy Proven Acute Rejection (BPAR) According to Banff Criteria up to 12 Months Post-Transplant |
8.0; 8.2 | — |
| SECONDARY Percentage of Participants With Graft Loss |
2.2; 5.6 | 0.2611 |
| SECONDARY Graft Survival |
12.9; 12.9 | — |
| SECONDARY Overall Survival (OS) at Month 12 - Percentage of Participants With an Event |
8.9; 11.1 | 0.7091 |
| SECONDARY Overall Survival at Month 12 |
12.9; 12.9 | — |
| SECONDARY Percentage of Participants by Graft Histology at 12 Months Post-Transplant - Central Review |
4.8; 11.4; 4.8; 17.1; 0.0; 0.0 | — |
Eligibility Criteria
Inclusion Criteria
- adult patients, >=18 years of age;
- recipient of a first orthotopic liver transplant.
Exclusion Criteria
- history of organ transplants;
- patient receiving a multi-organ transplant;
- calculated creatinine clearance <=30mL/min before transplant;
- leukocyte count < 2000/mm3 at randomization;
- history of cancer within past 5 years, except for successfully treated basal cell or squamous cell cancer, or in situ cervical cancer;
- pregnant or breast-feeding females, or females of childbearing age not using effective contraception.
Data sourced from ClinicalTrials.gov (NCT00545402). 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.