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

Liver Dysfunction Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02882113
• Other study ID #: AKR-ADVLT-2014-02
• Status: Recruiting
• Phase: Phase 4
• First received: August 24, 2016
• Last updated: August 30, 2016
• Start date: July 2016
• Est. completion date: December 2018

Study information

• Verified date: June 2016
• Source: Seoul National University Hospital
• Contact: Sung-Eun Kim
• Phone: +82-10-6361-7139
• Email: loveu0322[@]gmail.com
• Is FDA regulated: No
• Health authority: South Korea: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: December 2018
• Est. primary completion date: August 2018
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 19 Years and older

Eligibility

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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Liver Diseases
• Liver Dysfunction

Intervention

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

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	liver function abnormality rate		24 Weeks	Yes