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

Phase 2 Completed 200 enrolled Novartis Pharmaceuticals

RandomizedParallel-groupQuadruple-blindPrevention

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.

Timeline

Start: 2010-04
Primary completion: 2012-07
Completion: 2012-07

Publications

Results Pascher A, De Simone P, Pratschke J, Salame E, Pirenne J, Isoneimi H, Bijarnia M, Krishnan I, Klupp J. Protein kinase C inhibitor sotrastaurin in de novo liver transplant recipients: a randomized phase II trial. Am J Transplant. 2015 May;15(5):1283-92. doi: 10.1111/ajt.13175. Epub 2015 Feb 12.

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	Mycophenolate Mofetil	Small molecule	1000 mg	—
Comparator	Tacrolimus	Small molecule	—	—
Subject	sotrastaurin	Small molecule	200 mg	—
Subject	sotrastaurin	Small molecule	300 mg	—

Indications

No indication recorded.