Efficacy, Safety, Tolerability, Pharmacokinetics of Sotrastaurin-tacrolimus vs. Mycophenolic Acid-tacrolimus in de Novo Liver Transplant Patients

• Status: Completed
• Trial end date: 2012-07-01
• Target enrollment: 0
• Participant gender: All

Summary

This study will assess the safety and efficacy of different doses of sotrastaurin when combined with tacrolimus for the prevention of acute rejection after de novo liver transplantation.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Novartis Pharmaceuticals
• Treatments: Mycophenolic Acid; Tacrolimus

Criteria

Inclusion criteria:

• Recipients of any race, 18 years or older

• Recipients of primary de novo orthotopic liver transplant from a deceased donor

• Recipients of a kidney with a cold ischemia time < 30 hours

• HCV-negative recipients

Exclusion criteria:

• Prior organ/cellular transplant or multiple organ transplant

• MELD-score > 35

• HCC > Milan criteria

• Donor age < 12 years

• Cold ischemia > 15 hours

• Patients who are treated with drugs that are strong inducers or inhibitors of cytochrome P450 3A4 (CYP3A4) or drugs with QT-prolonging properties

Other protocol-defined inclusion/exclusion criteria may apply