- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01388387
Pharmacogenetic Study of Tacrolimus in Hepatic Transplant (CYPTAC'H)
Impact of Donor and Recipient CYP3A5 Genetic Polymorphism on Tacrolimus Exposure in Patients With Hepatic Transplant
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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Rennes, France, 35033
- Service des Maladies du Foie - Hôpital de Pontchaillou
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Adults (>18 years) of Caucasian origin,
- with hepatic transplant,
- who are going to be treated by tacrolimus, and
- who gave free, well-informed and written consent.
Non-inclusion Criteria:
- Participation to another protocol incompatible with the study,
- HIV patients with antiretroviral treatment,
- Patients with legal guardianship or deprived of freedom.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Tacrolimus pharmacokinetics
|
tacrolimus pharmacokinetics over 12 hours
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Exposure to tacrolimus after the first administration, using tacrolimus area under curve (AUC) between 0 and 12 hours, weighted by the dose administered.
Time Frame: 12 hours
|
12 hours
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Pharmacokinetics after the first administration and after 7 days of treatment
Time Frame: 7 days
|
Maximal concentration, time needed to reach maximal concentration, residual concentration 12 hours after drug administration, terminal elimination half-life, systemic clearance, AUC 0-12h/dose.
|
7 days
|
Clinical follow-up during the 3 months post transplantation
Time Frame: 3 months
|
Prescribed tacrolimus dose, tolerance of tacrolimus (hypertension, diabetes, renal insufficiency, neurological troubles) and signs of liver rejection assessed at each follow-up visit.
|
3 months
|
Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Marie-Clémence VERDIER, PharmD, Rennes University Hospital
- Study Chair: Eric Bellissant, MD, PhD, Rennes University Hospital
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2010-022488-36
- CIC0203/129 (Other Identifier: Center for Clinical Research of Rennes University Hospital)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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