bezafibrate for post operated bilirary atresia

• Register: JPRN
• Last refreshed on: 17 October 2023
• Main ID: JPRN-jRCTs031210066
• Date of registration: 06/05/2021
• Prospective Registration: Yes
• Primary sponsor: Terui Keita
• Public title: bezafibrate for post operated bilirary atresia
• Scientific title: Prospective study of bezafibrate for post operated bilirary atresia
• Date of first enrolment: 06/05/2021
• Target sample size: 10
• Recruitment status: Recruiting
• URL: https://jrct.niph.go.jp/latest-detail/jRCTs031210066
• Study type: Interventional
• Study design: single arm study, open(masking not used), no treatment control/standard of care control, single assignment, treatment purpose
• Phase: 2

Contacts

• Name: Keita Terui
• Affiliation: Chibe University Hospital

• Name: Yunosuke Kawaguchi
• Affiliation: Chibe University Hospital

Key inclusion & exclusion criteria

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.

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

Health Condition(s) or Problem(s) studied

Biliary Atresia
Obstructive jaundice

D001656

Obstructive jaundice

Intervention(s)

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

Primary Outcome(s)

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

Secondary Outcome(s)

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 )

Source(s) of Monetary Support

Chiba University Hospital

Ethics review

Status: Approval
Approval date:
Contact:

[e-mail]

Chiba University Certified Clinical Research Review Board

[phone]

[e-mail]