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JAPANESE
国立保健医療科学院
JRCT ID: jRCTs031210066

Registered date:06/05/2021

bezafibrate for post operated bilirary atresia

Basic Information

Recruitment status Complete
Health condition(s) or Problem(s) studiedBiliary Atresia
Date of first enrollment06/05/2021
Target sample size10
Countries of recruitment
Study typeInterventional
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 OutcomeAmount of ALP change between Week 12 and Week 0 (baseline)
Secondary OutcomeTest 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
GenderBoth
Include criteria1) 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 criteria1) 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

Contact

Public contact
Name Yunosuke Kawaguchi
Address 1-8-1 Inohana, Chuo-ku, Chiba 260-8677, Japan Chiba Japan 260-8677
Telephone +81-43-222-7171
E-mail yunosuke.kawaguchi@chiba-u.jp
Affiliation Chibe University Hospital
Scientific contact
Name Keita Terui
Address 1-8-1 Inohana, Chuo-ku, Chiba 260-8677, Japan Chiba Japan 260-8677
Telephone +81-43-222-7171
E-mail kta@chiba-u.jp
Affiliation Chibe University Hospital