A prospective trial of Elobixibat Hydrate

A prospective trial of Elobixibat Hydrate in preventing hepatotoxicity for biliary atresia

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCTs041240187

Enrollment

Registered

2025-02-10

Start date

2025-02-10

Completion date

Unknown

Last updated

2025-07-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

biliary atresia jaundice

Interventions

After Kasai surgery, in the group taking oral GOOFICE, 0.1 - 0.3 mg/kg once daily before meals for one year postoperatively. Patient assessments are performed at 1, 3, 6, 9, 12 and 24 months postopera

D008511

medicine

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Disease: Patients with a diagnosis of biliary atresia for whom surgery is planned Age: all ages Gender: any gender

Exclusion criteria

Exclusion criteria: Patients with significantly impaired major organ function at the time of diagnosis and fulfilling one of the following criteria Patients with confirmed or suspected intestinal obstruction due to tumour, hernia,etc

Design outcomes

Primary

Measure	Time frame
serum bile acid concentration	—

Secondary

Measure	Time frame
Native liver survival rate (proportion of patients surviving without liver transplantation) at 1 and 2 years after surgery, jaundice free rate (proportion of patients with serum total bilirubin < 1.5 mg/dL at 6 months, 1 and 2 years after surgery), serum hepatobiliary enzyme levels, postoperative course (length of days in hospital after surgery, adverse events)	—

Contacts

Public ContactDaiki Kato

Nagoya University Hospital

katodk@med.nagoya-u.ac.jp+81-52-744-2959

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Feb 4, 2026