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Influence of CYP3A5 Polymorphism on Liver Function Abnormality and the Trough Level Change After Conversion | Clinical Trials | Clareo Health

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Influence of CYP3A5 Polymorphism on Liver Function Abnormality and the Trough Level Change After Conversion

Influence of CYP3A5 Polymorphism on Liver Function Abnormality and the Trough Level Change After Conversion From Tacrolimus (Bid) to Advagraf® (qd) in Stable Liver Transplant Recipients

NCT02882113•Seoul National University Hospital

View on ClinicalTrials.gov

Summary

This study is a multicenter, single-arm, open-label, 24 weeks, and investigator-initiated clinical trial to assess the influence of CYP3A5 polymorphism on liver function abnormality and the trough level change after conversion to Advagraf® in liver transplant recipients.

Detailed Description

All subjects who are liver transplant recipients taking Tacrolimus bid and adaptable to be registered for the study will be classified by expressive or non-expressive CYP3A5 polymorphism genotype and Advagraf® will be administered same dose as Tacrolimus bid der day in 24 weeks. All subjects should check whether being registered in the hospital based on CYP3A5 polymorphism genotype during screening visit. Registered subjects will visit seven times to the hospital during the study which includes screening visit and adverse reaction, acute rejection, and trough level will be tested during this period. Subjects who are additionally agreed for PK study will be hospitalized with the state of Tacrolimus bid therapy one day ago before taking IP. On the first day of hospitalization, his/her blood will be collected. At week 1 (plus seven days) after conversion to Advagraf®, his/her blood will be collected for PK analysis.

Eligibility

Age

19 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•19 years old and above.
•Patients who previously have received a liver transplant over the last six months and within last three years.
•Patients who are on Tacrolimus immunosuppressive therapy twice a day for at least two weeks.
•During Tacrolimus immunosuppressive therapy twice a day for at least two weeks, patients who have following conditions.
•* Patients who have normal liver function and renal function.
•* Patients who have been monitored without complication such as acute rejection.
•Patients willing to sign his/her consent.

Exclusion Criteria

•Patients who have Tacrolimus trough level resulted as 2 ng/mg at the baseline.
•Patients who are on steroid therapy due to positive result of acute rejection test before the baseline.
•Patients who have received a transplant besides liver.
•Patients who are allergic to IP or macrolide compounds.
•Patients who are on cyclosporine, bosentan, or potassium sparing diuretic.
•Patients with genetic diseases such as galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption.
•Pregnant or lactating women.
•Patients not willing to adhere to study procedures/treatments.

Locations (1)

Seoul National University Hospital

Seoul, South Korea

Key Dates

Start Date

July 1, 2016

Primary Completion Date

August 1, 2018

Completion Date

December 1, 2018

Last Updated

August 31, 2016

Enrollment

ESTIMATED participants

Conditions

Liver Dysfunction

Interventions

Advagraf

DRUG

Contacts

Sung-Eun Kim

CONTACT

+82-10-6361-7139 loveu0322@gmail.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: August 31, 2016Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Influence of CYP3A5 Polymorphism on Liver Function Abnormality and the Trough Level Change After Conversion

Inclusion Criteria

Exclusion Criteria

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