bezafibrate for post operated bilirary atresia

JRCT ID: jRCTs031210066

Registered date:06/05/2021

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Biliary Atresia
• Date of first enrollment: 06/05/2021
• Target sample size: 10
• Study type: Interventional
• Intervention(s): Bezafibrate 400 mg/day is orally administered to patients after biliary atresia in two divided doses after breakfast and dinner.

Outcome(s)

• Primary Outcome: Amount of ALP change between Week 12 and Week 0 (baseline)
• Secondary Outcome: 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 )

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: < 80age old
• Gender: Both

Include 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.

Exclude 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.

Related Information

• Primary Sponsor: Terui Keita
• Source(s) of Monetary Support: Chiba University Hospital