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Pharmacokinetic Study of AEB071 in Patients Following Liver Transplantation

NCT ID: NCT00545259

Last Updated: 2020-12-08

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

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

13 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-10-31

Brief Summary

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The study will evaluate the pharmacokinetic profile of AEB071 in the immediate post-transplant period in patients who have undergone their first liver transplant.

Detailed Description

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Conditions

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de Novo Liver Transplantation

Keywords

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Organ transplant, liver, pharmacokinetics, AEB071, immunosuppression

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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1

AEB071

Group Type EXPERIMENTAL

AEB071

Intervention Type DRUG

Interventions

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AEB071

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Primary liver transplant recipients.
* Transplanted liver functioning at an acceptable level by 24 h post-transplant
* Patients started on tacrolimus therapy within 12 h post-transplant

Exclusion Criteria

* Previous transplantation or multiple organs transplantation
* Acute rejection
* Non-heart beating donor
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Novartis

INDUSTRY

Sponsor Role lead

Responsible Party

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Novartis

Principal Investigators

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Novartis

Role: PRINCIPAL_INVESTIGATOR

Investigator site

Locations

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Novartis investigative site

Berlin, , Germany

Site Status

Novartis Investigative Site

Padua, , Italy

Site Status

Novartis investigative site

Zurich, , Switzerland

Site Status

Countries

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Germany Italy Switzerland

Related Links

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https://www.novctrd.com/ctrdweb/trialresult/trialresults/pdf?trialResultId=2641

Results from CAEB071B2101 can be found on the Novartis Clinical Trial Results website

Other Identifiers

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CAEB071B2101

Identifier Type: -

Identifier Source: org_study_id