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Pharmacogenetic Study of Tacrolimus in Hepatic Transplant (CYPTAC'H)

NCT01388387 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 154

Last updated 2023-05-24

No results posted yet for this study

Summary

The choice of an immunosuppressant after hepatic transplant is now more difficult than before because of the increasing number of drugs available.

Pharmacokinetic, pharmacodynamic and pharmacogenetic information can help to choose the best treatment and the best dose for each patient. The genetic polymorphism of enzymes metabolizing treatments can affect their efficacy and safety. Concerning tacrolimus, CYP3A5 activity is a major determinant of the dose needed to reach target concentrations. This study is aimed at evaluating the impact of both donor and recipient CYP3A5 genetic polymorphisms on tacrolimus exposure in patients with hepatic transplant.

Conditions

  • Hepatic Transplantation

Interventions

OTHER

Tacrolimus pharmacokinetics

tacrolimus pharmacokinetics over 12 hours

Sponsors & Collaborators

  • Rennes University Hospital

    lead OTHER

Principal Investigators

  • Eric BELLISSANT, MD, PhD · Rennes University Hospital

  • Marie-Clémence VERDIER, PharmD · Rennes University Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-02-22
Primary Completion
2018-07-31
Completion
2018-07-31

Countries

  • France

Study Locations

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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 NCT01388387 on ClinicalTrials.gov