Phase 3
Completed N=282
Extension Study to Evaluate the Long-term Efficacy and Safety of Everolimus in Liver Transplant Recipients
Liver Transplant Recipient
Source: ClinicalTrials.gov NCT01150097 ↗
Enrolled (actual)
282
Serious AEs
30.5%
Results posted
May 2014
Primary outcomePrimary: Incidence Rate of Composite Efficacy Failure Defined as Treated Biopsy Proven Acute Rejection (tBPAR ), Graft Loss or Death — 2; 1; 3 Participants
Summary
The reason for this extension is to evaluate the long-term safety and efficacy of two concentration-controlled everolimus regimen in de novo liver transplant recipients. The most important long-term safety assessments include evaluation of renal function, progression of HCV related allograft fibrosis, and other treatment related effects at Month 36 post-transplantation compared to extension baseline (Months 24 post-transplantation).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Incidence Rate of Composite Efficacy Failure Defined as Treated Biopsy Proven Acute Rejection (tBPAR ), Graft Loss or Death |
1; 0 | — |
| PRIMARY Incidence Rate of Composite Efficacy Failure Defined as Treated Biopsy Proven Acute Rejection (tBPAR ), Graft Loss or Death |
1; 0 | — |
| PRIMARY Incidence Rate of Composite Efficacy Failure Defined as Graft Loss or Death |
0; 0 | — |
| PRIMARY Incidence Rate of Composite Efficacy Failure Defined as Graft Loss or Death |
0; 0 | — |
| PRIMARY Change in Renal Function |
-0.9; 2.5; -3.3 | — |
| SECONDARY Incidence Rate of tBPAR |
0; 1; 2 | — |
Eligibility Criteria
Inclusion Criteria
- Written informed consent
- Ability and willingness to adhere to study regimen
- Completed core study with assigned regimen;
Exclusion Criteria
Patients fulfilling any of the following criteria are not eligible for inclusion in this study:
- Severe hypercholesterolemia or hypertriglyceridemia.
- Low platelet count.
- Low white blood cell count.
- Positive test for human immunodeficiency virus (HIV).
- Systemic infection requiring active use of IV antibiotics.
- Patients in a critical care setting.
- Use of prohibited medication.
- Use of immunosuppressive agents not utilized in the protocol.
- Hypersensitivity to any of the study drugs or similar drugs.
- Pregnant or nursing (lactating) women
- Women of child-bearing potential not using a highly effective method of birth control.
Other protocol-defined inclusion/exclusion criteria may apply
Data sourced from ClinicalTrials.gov (NCT01150097). 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.