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

NCT01128335 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2020-12-22

No results posted yet for this study

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

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

Sponsors & Collaborators

Principal Investigators

  • Novartis Pharmaceuticals · Novartis Pharmaceuticals

  • Novartis Pharmceuticals · Novartis Pharmaceuticals

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-04-30
Primary Completion
2012-07-31
Completion
2012-07-31

Countries

  • United States
  • Argentina
  • Austria
  • Belgium
  • Canada
  • Czechia
  • Finland
  • France
  • Germany
  • Italy
  • Spain
  • Switzerland

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01128335 on ClinicalTrials.gov