臨床研究等提出・公開システム

Prospective study of bezafibrate for post operated bilirary atresia

bezafibrate for post operated bilirary atresia

Terui Keita

Chibe University Hospital

1-8-1 Inohana, Chuo-ku, Chiba 260-8677, Japan

kta@chiba-u.jp

Kawaguchi Yunosuke

Chibe University Hospital

1-8-1 Inohana, Chuo-ku, Chiba 260-8677, Japan

+81-43-222-7171

yunosuke.kawaguchi@chiba-u.jp

Complete

May. 06, 2021

Interventional

single arm study

open(masking not used)

no treatment control/standard of care control

single assignment

treatment purpose

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.

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.

Both

Biliary Atresia

Bezafibrate 400 mg/day is orally administered to patients after biliary atresia in two divided doses after breakfast and dinner.

Obstructive jaundice

D001656

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

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 )

+81-43-226-2616

No

none