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

> **NCT01128335** · PHASE2 · COMPLETED · sponsor: **Novartis Pharmaceuticals** · enrollment: 200 (actual)

## Conditions studied

- Liver Transplantation

## Interventions

- **DRUG:** MMF(1000mg bid) + tacrolimus + standard of care medications
- **DRUG:** sotrastaurin (200mg bid) + tacrolimus + standard of care medications
- **DRUG:** sotrastaurin (200mg bid) + tacrolimus + standard of care medications
- **DRUG:** sotrastaurin (300 mg bid) + tacrolimus + standard of care medications

## Key facts

- **NCT ID:** NCT01128335
- **Lead sponsor:** Novartis Pharmaceuticals
- **Sponsor class:** INDUSTRY
- **Phase:** PHASE2
- **Study type:** INTERVENTIONAL
- **Status:** COMPLETED
- **Start date:** 2010-04
- **Primary completion:** 2012-07
- **Final completion:** 2012-07
- **Target enrollment:** 200 (ACTUAL)
- **Last updated:** 2020-12-22


## Primary source

ClinicalTrials.gov registry: https://clinicaltrials.gov/study/NCT01128335

## Citation

> US National Library of Medicine, ClinicalTrials.gov registration NCT01128335, "Efficacy, Safety, Tolerability, Pharmacokinetics of Sotrastaurin-tacrolimus vs. Mycophenolic Acid-tacrolimus in de Novo Liver Transplant Patients". Retrieved via AI Analytics 2026-06-01 from https://api.ai-analytics.org/clinical/NCT01128335. Licensed CC0.

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