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

Completed · Phase 2

Conditions studied: Liver Transplantation

In brief

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.

Key facts

Study ID

NCT01128335

Run by

Novartis Pharmaceuticals

People needed

200

Starts

2010-04-01

Expected to finish

2012-07-01

Last updated by the study team

2020-12-22

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Novartis Investigative Site — Los Angeles, California, United States
• Novartis Investigative Site — San Francisco, California, United States
• Novartis Investigative Site — Detroit, Michigan, United States
• Novartis Investigative Site — Minneapolis, Minnesota, United States
• Novartis Investigative Site — Rochester, Minnesota, United States
• Novartis Investigative Site — Cincinnati, Ohio, United States
• Novartis Investigative Site — Dallas, Texas, United States
• Novartis Investigative Site — Houston, Texas, United States
• Novartis Investigative Site — CABA, Buenos Aires, Argentina
• Novartis Investigative Site — CABA, Buenos Aires, Argentina
• Novartis Investigative Site — San Martín, Buenos Aires, Argentina
• Novartis Investigative Site — Innsbruck, Austria
• Novartis Investigative Site — Vienna, Austria
• Novartis Investigative Site — Ghent, Belgium
• Novartis Investigative Site — Leuven, Belgium
• Novartis Investigative Site — London, Ontario, Canada
• Novartis Investigative Site — Prague, Czech Republic, Czechia
• Novartis Investigative Site — Brno, Czechia
• Novartis Investigative Site — HUS, Finland
• Novartis Investigative Site — Bordeaux, France
• Novartis Investigative Site — Chambray-lès-Tours, France
• Novartis Investigative Site — Créteil, France
• Novartis Investigative Site — Paris, France
• Novartis Investigative Site — Strasbourg, France
• Novartis Investigative Site — Villejuif, France

Full record on ClinicalTrials.gov

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