Prospective study of pemafibrate for post pancreaticoduodenectomy steatotic liver disease

JRCT ID: jRCTs061240078

Registered date:08/11/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: steatotic liver disease
• Date of first enrollment: 08/11/2024
• Target sample size: 42
• Study type: Interventional
• Intervention(s): Patients with post pancreaticoduodenectomy refractory steatotic liver disease who are administrating pancrelipase will be assigned to the study. Subjects assigned to the pemafibrate group (intervention group) will receive pemafibrate orally at a dose of 0.2 mg per day. This will be administered for 24 consecutive weeks.

Outcome(s)

• Primary Outcome: Percentage of those with liver CT value 40HU or more on non-contrast CT at 24 weeks

Secondary Outcome

1. Percentage change in liver CT value on non-contrast CT
2. Percent change in Alb, ALT, GGT, Zn, TG, T-Cho, HDL-Cho, LDL-Cho, ALBI score and FIB-4 index
3. Percent change in weight and BMI
4. Adverse events and side effects

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

1. 18 age old over
2. Patients taking pancrelipase at a dose of 900 mg/day or more for at least 12 weeks after pancreaticoduodenectomy
3. Patients has passed More than 1 year since pancreaticoduodenectomy
4. Patients with steatotic liver disease with CT value <40HU on non-contrast CT
5. Patienst who have been fully informed consent

Exclude criteria

1. Patients with complications of other liver diseases such as active viral hepatitis, autoimmune hepa
titis, primary cholestatic cholangitis, drug-induced liver injury
2. Alcohol consumption, 30 g/day or more (men) or 20 g/day or more (women) in terms of ethanol
3. Patients taking concomitantly prohibited drugs
4. Patients with a history of allergy to pemafibrate
5. Patients with liver cirrhosis of Child-Pugh Classification B or C
6. Patients with biliary stones or biliary obstruction
7. Prior treatment with fibrates or SPPARM within 12 weeks of obtaining consent
8. Being pregnant or possibly pregnant
9. Patients who judged as inappropriate candidate by the chief medical examine

Related Information

• Primary Sponsor: Matsumoto Kazuyuki