bezafibrate for post operated bilirary atresia

Phase 2

Recruiting

• Conditions: Biliary Atresia; Obstructive jaundice; D001656

• Registration Number: JPRN-jRCTs031210066
• Lead Sponsor: Terui Keita

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-05-06
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

1) Postoperative patients with biliary atresia
2) Patients whose serum ALP value exceeds the normal upper limit of the institutional standard at two points: from 1 year to 28 days before consent acquisition and at the time of consent acquisition
3) Patients aged 18 to 80 at the time of consent
4) Patients who have received sufficient explanation before participating in this study, and who have obtained the patient's and substitute voluntary written consent after sufficient understanding.

Exclusion Criteria

1) Patients whose T-Bil value is 5 times the upper limit of the normal value of the facility standard and IU / L or more
2) Patients whose ALP value is 10 times the upper limit of the normal value of the facility standard and IU / L or mor
3) Patients after liver transplantation
4) Patients who changed the drug dosage and treatment within 3 months before administration of the study drug
5) Patients with cholangitis (the criteria for moderate acute cholangitis in the Acute Cholangitis / Cholecystitis Clinical Practice Guideline 2018) in 3 months before administration of the study drug
6) Patients who used bezafibrate for 3 months before the start
7) Patients with renal dysfunction whose Creatinine clearance <60 mL / min or eGFR <60 mL / min / 1.73 m2 can be calculated using the prediction formula.
8) Patients whose CK value is at least twice the upper limit of the normal value of the facility standard
9) Patients who are pregnant, may become pregnant, within 28 days after giving birth, or breastfeeding
10) Patients with allergies to bezafibrate
11) In addition, patients who are judged by the investigator or the investigator to be inappropriate for conducting this study safely.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Amount of ALP change between Week 12 and Week 0 (baseline)

Secondary Outcome Measures

Name	Time	Method
Test values and changes g-GTP, Bil, AST, ALT, total bile acid, LDL-Cho, TG, T-Cho at each time point (Week-12 , Week0 ,Week12 ,Week24 )