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

Novartis

Status and phase: Completed; Phase 2

Conditions: Liver Transplantation

Treatments: Drug: sotrastaurin (300 mg bid) + tacrolimus + standard of care medications; Drug: MMF(1000mg bid) + tacrolimus + standard of care medications; Drug: sotrastaurin (200mg bid) + tacrolimus + standard of care medications

Study type: Interventional

Funder types: Industry

Identifiers

NCT01128335

2007-001776-36

CAEB071B2201

Details and patient eligibility

About

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.

Enrollment: 200 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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200 participants in 4 patient groups

Arm 1

Active Comparator group

Description:

MMF(1000mg bid) + tacrolimus + standard of care medications

Treatment:

Drug: MMF(1000mg bid) + tacrolimus + standard of care medications

Arm 2

Experimental group

Description:

sotrastaurin (200mg bid) + tacrolimus + standard of care medications

Treatment:

Drug: sotrastaurin (200mg bid) + tacrolimus + standard of care medications

Drug: sotrastaurin (200mg bid) + tacrolimus + standard of care medications

Arm 3

Experimental group

Description:

sotrastaurin (200mg bid) + tacrolimus + standard of care medications

Treatment:

Drug: sotrastaurin (200mg bid) + tacrolimus + standard of care medications

Drug: sotrastaurin (200mg bid) + tacrolimus + standard of care medications

Arm 4

Experimental group

Description:

sotrastaurin (300 mg bid) + tacrolimus + standard of care medications

Treatment:

Drug: sotrastaurin (300 mg bid) + tacrolimus + standard of care medications