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

• Status: Unknown status
• Trial end date: 2018-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Seoul National University Hospital
• Treatments: Tacrolimus

Criteria

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.