Fenofibrate in Combination With Ursodeoxycholic Acid in Primary Biliary Cholangitis

Primary Biliary Cholangitis Clinical Trial

Official title:

Fenofibrate in Combination With Ursodeoxycholic Acid in Primary Biliary Cholangitis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06174402
• Other study ID #: KY-20232219-C-1
• Status: Recruiting
• Phase: Phase 2/Phase 3
• Start date: August 21, 2023
• Est. completion date: December 31, 2025

Study information

• Verified date: December 2023
• Source: Xijing Hospital of Digestive Diseases
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The main objectives of the study were to assess the effects of fenofibrate on serum alkaline phosphatase, as a composite endpoint and on safety in participants with primary biliary cholangitis (PBC)

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 184
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• Must have provided written informed consent
• Age 18-75 years;
• BMI 17-28 kg/m2
• Male or female with a diagnosis of PBC, by at least two of the following criteria:

1. History of alkaline phosphatase(ALP) above upper limit of normal(ULN) for at least six months;

2. Positive Anti-mitochondrial antibody (AMA) titers (>1/40 on immunofluorescence or M2 positive by enzyme linked immunosorbent assay (ELISA) or positive PBC-specific antinuclear antibodies;

3. Documented liver biopsy result consistent with PBC.

• Incomplete response to UDCA defined by 1 x ULN< ALP <= 1.67 x ULN
• Taking UDCA for at least 6 months (stable dose for = 3 months) prior to Day 0

Exclusion Criteria:

• History or presence of other concomitant liver diseases.
• ALT or AST > 5×ULN, total bilirubin(TBIL) > 3×ULN.
• If female: known pregnancy, or has a positive urine pregnancy test (confirmed by a positive serum pregnancy test), or lactating.
• Allergic to fenofibrate or ursodeoxycholic acid.
• Taking hepatotoxic drugs (e.g., dapsone, erythromycin, fluconazole, ketoconazole, rifampicin) for more than 2 weeks within 6 months, and long-term hormonal users. Recurrent variceal bleeding, poorly controlled hepatic encephalopathy or refractory ascites.
• Patients with a history of severe cardiac, cerebrovascular, renal, respiratory disease or functional failure, and psychiatric disorders (including those due to alcohol and drug abuse).
• Creatinine >1.5×ULN and creatinine clearance <60 ml/min.
• Currently using statins (such as pravastatin, fluvastatin, and simvastatin), other fibrates (such as gemfibrozil and bezafibrate), and drugs structurally similar to fenofibrate (like ketoprofen).
• Planned to receive an organ transplant or an organ transplant recipient.
• Needing Liver transplantation within 1 year according to the Mayo Rick score.
• Any other condition(s) that would compromise the safety of the subject or compromise

Related Conditions & MeSH terms

• Cholangitis
• Liver Cirrhosis, Biliary
• Primary Biliary Cholangitis

Intervention

Drug:
• Fenofibrate
Fenofibrate 200 mg/day
• Placebo
1 tablet/ day
• UDCA
UDCA 13-15mg/kg/day

Locations

Country	Name	City	State
China	Xijing Hospital	Xi'an	Shaanxi

Sponsors (1)

Lead Sponsor	Collaborator
Han Ying

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of patients with biochemical response	The normalisation of Alkaline Phosphatase	48 weeks
Secondary	Percentage of patients having biochemical response	The normalisation of Alkaline Phosphatase at 4, 12, 24, and 36 weeks	4, 12, 24 and 36weeks
Secondary	Assessment of the pruritus	Change From Baseline in Pruritus as Assessed by Visual Analogue Scale (VAS) Total Score for Fatigue and Pruritus. (0-10, higher scores mean a worse outcome)	4, 12, 24, 36, and 48 weeks
Secondary	Assessment of the fatigue	Change From Baseline in Fatigue as Assessed by Visual Analogue Scale (VAS) Total Score for Fatigue and Pruritus. (0-10, higher scores mean a worse outcome)	4, 12, 24, 36, and 48 weeks
Secondary	Percentage of patients having biological or clinical adverse events	Increase of creatinine, blood urea nitrogen, alanine aminotransferase and aspartate aminotransferase	4, 12, 24, 36, and 48 weeks
Secondary	Survival without transplantation and hepatic impairment	Occurrence of ascites, variceal bleeding, hepatic encephalopathy, liver-transplantation, or death	48 weeks