NCT01128335

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

A 24-month Randomized Multicenter Study Evaluating Efficacy, Safety, Tolerability and Pharmacokinetics of Sotrastaurin and Tacrolimus vs. a Tacrolimus/Mycophenolate Mofetil-based Control Regimen in de Novo Liver Transplant Recipients

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 200 (actual)
• Sponsor: Novartis Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Liver Transplantation

Interventions

Type	Name	Description
DRUG	MMF(1000mg bid) + tacrolimus + standard of care medications	MMF(1000mg bid) + tacrolimus + standard of care medications
DRUG	sotrastaurin (200mg bid) + tacrolimus + standard of care medications	sotrastaurin (200mg bid) + tacrolimus + standard of care medications
DRUG	sotrastaurin (200mg bid) + tacrolimus + standard of care medications	sotrastaurin (200mg bid) + tacrolimus + standard of care medications
DRUG	sotrastaurin (300 mg bid) + tacrolimus + standard of care medications	sotrastaurin (300 mg bid) + tacrolimus + standard of care medications

Timeline

• Start date: 2010-04-01
• Primary completion: 2012-07-01
• Completion: 2012-07-01
• First posted: 2010-05-21
• Last updated: 2020-12-22

Locations

39 sites across 12 countries: United States, Argentina, Austria, Belgium, Canada, Czechia, Finland, France, Germany, Italy, Spain, Switzerland