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Everolimus in de Novo Liver Transplantation: a Multicentre Randomized Study

NCT01423708 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 117

Last updated 2012-07-18

No results posted yet for this study

Summary

Safety and Efficacy of Everolimus in adult de novo liver transplant recipients.

Conditions

Interventions

DRUG

Everolimus

Administration of Everolimus within 24 hours from the time of randomization (7 days from the time of transplantation) in association with Tacrolimus and steroids. The first dose level of the trough will be performed at day 7 after initiation of therapy. After the reaching an Everolimus trough level of \>5ng/ml (final target 6-12 ng/ml), there will be a gradual weaning of tacrolimus (bringing Tacrolimus blood levels \<5 ng/ml) with discontinuation of Tacrolimus within 30 days after transplantation when possible.

Sponsors & Collaborators

  • Azienda Ospedaliera di Padova

    lead OTHER

Principal Investigators

  • Umberto Cillo, MD · Azienda Ospedaliera di Padova

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-02-28
Primary Completion
2014-01-31
Completion
2014-01-31

Countries

  • Italy

Study Locations

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Entities

Drugs
Diseases

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 NCT01423708 on ClinicalTrials.gov