Efficacy and Safety of Everolimus in Liver Transplant Recipients of Living Donor Liver Transplants

ClinicalTrials.gov ID: NCT01888432

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Official title

A 24 Month, Randomized, Controlled, Study to Evaluate the Efficacy and Safety of Concentration-controlled Everolimus Plus Reduced Tacrolimus Compared to Standard Tacrolimus in Recipients of Living Donor Liver Transplants and Long Term Extension to Evaluate the Efficacy and Safety of Concentration-controlled Everolimus Plus Reduced Tacrolimus Compared to Standard Tacrolimus in Recipients of Living Donor Liver Transplants in Japan

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

The purpose of this trial was to demonstrate the efficacy and safety of everolimus in combination with reduced tacrolimus, compared to tacrolimus control, in living donor liver transplant recipients.

Study identification

NCT ID: NCT01888432
Recruitment status: Completed
Study type: Interventional
Phase: Phase 3
Lead sponsor: Novartis Pharmaceuticals; Industry
Enrollment: 285 participants

Conditions and interventions

Conditions

Liver Transplantation

Interventions

Everolimus + reduced tacrolimus Drug
Standard tacrolimus Drug

Drug

Eligibility (public fields only)

Age range: 18 Years and older
Sex: All
Healthy volunteers: Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date: Sep 25, 2013 (Actual)
Primary completion: Oct 19, 2016 (Actual)
Completion: Apr 21, 2018 (Actual)
Last update posted: Mar 18, 2019

2013 – 2018

United States locations

U.S. sites: 9
U.S. states: 7
U.S. cities: 9

Facility	City	State	ZIP	Site status
Novartis Investigative Site	Los Angeles	California	90033	—
Novartis Investigative Site	San Francisco	California	94143	—
Novartis Investigative Site	Baltimore	Maryland	21201	—
Novartis Investigative Site	Boston	Massachusetts	02114	—
Novartis Investigative Site	Burlington	Massachusetts	01805	—
Novartis Investigative Site	Detroit	Michigan	48202	—
Novartis Investigative Site	Minneapolis	Minnesota	55455	—
Novartis Investigative Site	New York	New York	10032	—
Novartis Investigative Site	Charlottesville	Virginia	22908	—

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 33 non-U.S. sites.

About this trial record page

What this page shows: Public field values for ClinicalTrials.gov record NCT01888432, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do: No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from: Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh: Last update posted Mar 18, 2019 · Synced Nov 15, 2026