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

Sponsor
Seoul National University Hospital (Other)
Overall Status
Unknown status
CT.gov ID
NCT02882113
Collaborator
(none)
60
Enrollment
1
Location
2
Arms
29
Duration (Months)
2.1
Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
Phase 4

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
60 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
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
Study Start Date :
Jul 1, 2016
Anticipated Primary Completion Date :
Aug 1, 2018
Anticipated Study Completion Date :
Dec 1, 2018

Arms and Interventions

Arm Intervention/Treatment
Experimental: Expressor

CYP3A5 expressor; containing CYP3A5*1 wild-type allele(*1/*1 type & *1/*3 type) intervention: Advagraf conversion

Drug: Advagraf
same dose as Tacrolimus bid der day in 24 weeks
Other Names:
  • Tacrolimus

    		•
    Active Comparator: Non-expressor

    CYP3A5 non-expressor: without CYP3A5*1 allele( *3/*3 type) intervention: Advagraf conversion

    Drug: Advagraf
    same dose as Tacrolimus bid der day in 24 weeks
    Other Names:
  • Tacrolimus

    		•

    Outcome Measures

    Primary Outcome Measures

    1. liver function abnormality rate [24 Weeks]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    19 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Seoul National University Hospital Seoul Korea, Republic of

    Sponsors and Collaborators

    • Seoul National University Hospital

    Investigators

    • Principal Investigator: Kwang-Woong Lee, Dr., Seoul National University Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Seoul National University Hospital
    ClinicalTrials.gov Identifier:
    NCT02882113
    Other Study ID Numbers:
    • AKR-ADVLT-2014-02
    First Posted:
    Aug 29, 2016
    Last Update Posted:
    Aug 31, 2016
    Last Verified:
    Jun 1, 2016
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Additional relevant MeSH terms:
    Liver Diseases
    Tacrolimus

    Study Results

    No Results Posted as of Aug 31, 2016