MedDataX Logo

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

NCT ID: NCT01128335

Last Updated: 2020-12-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-04-30

Study Completion Date

2012-07-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Liver Transplantation

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Liver transplantation HCV-negative recipient deceased donor sotrastaurin oran transplantation tacrolimus

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Arm 1

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

Group Type ACTIVE_COMPARATOR

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

Intervention Type DRUG

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

Arm 2

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

Group Type EXPERIMENTAL

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

Intervention Type DRUG

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

Arm 3

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

Group Type EXPERIMENTAL

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

Intervention Type DRUG

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

Arm 4

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

Group Type EXPERIMENTAL

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

Intervention Type DRUG

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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

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

Intervention Type DRUG

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

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

Intervention Type DRUG

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

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

Intervention Type DRUG

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

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

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Novartis Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Novartis Pharmaceuticals

Role: STUDY_DIRECTOR

Novartis Pharmaceuticals

Novartis Pharmceuticals

Role: STUDY_DIRECTOR

Novartis Pharmaceuticals

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Novartis Investigative Site

Los Angeles, California, United States

Site Status

Novartis Investigative Site

San Francisco, California, United States

Site Status

Novartis Investigative Site

Detroit, Michigan, United States

Site Status

Novartis Investigative Site

Minneapolis, Minnesota, United States

Site Status

Novartis Investigative Site

Rochester, Minnesota, United States

Site Status

Novartis Investigative Site

Cincinnati, Ohio, United States

Site Status

Novartis Investigative Site

Dallas, Texas, United States

Site Status

Novartis Investigative Site

Houston, Texas, United States

Site Status

Novartis Investigative Site

CABA, Buenos Aires, Argentina

Site Status

Novartis Investigative Site

CABA, Buenos Aires, Argentina

Site Status

Novartis Investigative Site

San Martín, Buenos Aires, Argentina

Site Status

Novartis Investigative Site

Innsbruck, , Austria

Site Status

Novartis Investigative Site

Vienna, , Austria

Site Status

Novartis Investigative Site

Ghent, , Belgium

Site Status

Novartis Investigative Site

Leuven, , Belgium

Site Status

Novartis Investigative Site

London, Ontario, Canada

Site Status

Novartis Investigative Site

Prague, Czech Republic, Czechia

Site Status

Novartis Investigative Site

Brno, , Czechia

Site Status

Novartis Investigative Site

HUS, , Finland

Site Status

Novartis Investigative Site

Bordeaux, , France

Site Status

Novartis Investigative Site

Chambray-lès-Tours, , France

Site Status

Novartis Investigative Site

Créteil, , France

Site Status

Novartis Investigative Site

Paris, , France

Site Status

Novartis Investigative Site

Strasbourg, , France

Site Status

Novartis Investigative Site

Villejuif, , France

Site Status

Novartis Investigative Site

Berlin, , Germany

Site Status

Novartis Investigative Site

Essen, , Germany

Site Status

Novartis Investigative Site

Hamburg, , Germany

Site Status

Novartis Investigative Site

Hanover, , Germany

Site Status

Novartis Investigative Site

Heidelberg, , Germany

Site Status

Novartis Investigative Site

Regensburg, , Germany

Site Status

Novartis Investigative Site

Milan, MI, Italy

Site Status

Novartis Investigative Site

Padua, PD, Italy

Site Status

Novartis Investigative Site

Pisa, PI, Italy

Site Status

Novartis Investigative Site

Seville, Andalusia, Spain

Site Status

Novartis Investigative Site

L'Hospitalet de Llobregat, Catalonia, Spain

Site Status

Novartis Investigative Site

A Coruña, Galicia, Spain

Site Status

Novartis Investigative Site

Valencia, Valencia, Spain

Site Status

Novartis Investigative Site

Zurich, , Switzerland

Site Status

Countries

Review the countries where the study has at least one active or historical site.

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

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type RESULT
PMID: 25677074 (View on PubMed)

Related Links

Access external resources that provide additional context or updates about the study.

https://www.novctrd.com/ctrdweb/trialresult/trialresults/pdf?trialResultId=8843

Results for CAEB071B2201 from the Novartis Clinical Trials Website

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2007-001776-36

Identifier Type: -

Identifier Source: secondary_id

CAEB071B2201

Identifier Type: -

Identifier Source: org_study_id