A Study to Assess Efficacy and Safety of Bezafibrate in Patients With Primary Biliary Cholangitis

• Status: Active, not recruiting
• Trial end date: 2021-07-01
• Target enrollment: 0
• Participant gender: All

Summary

Up to 40% of patients with PBC have an inadequate response to standard treatment with Ursodeoxycholic Acid (UDCA), those patients represent the group in need for additional therapies, having increased risk of disease progression and decreased survival free of liver transplantation.

The main objective of the study is to evaluate safety and efficacy of bezafibrate plus ursodesoxicolic acid in patients with PBC and inadequate response to UDCA.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Instituto Mexicano del Seguro Social
• Treatments: Bezafibrate; Ursodeoxycholic Acid

Criteria

Inclusion Criteria:

• PBC diagnosis (consistent with American Association for the Study of Liver Disease [AASLD]:

• History of elevated alkaline phosphatase levels.

• Anti-mitochondrial antibodies positivity

• Histopathologic evidence of nonsuppurative cholangitis and destruction of small or medium- sized bile ducts.

• Use of ursodeoxycholic acid (UDCA) for at least 12 months at enrollment at a therapeutic dose (13 to 15 mg per Kg per day).

• Evidence of a suboptimal biochemical response to UDCA, defined by the presence of one of the Paris II criteria.

• Written informed consent.

• Age ≥ 18 years.

Exclusion Criteria:

• Hepatic decompensation (ascitis, variceal upper gastrointestinal bleeding, hepatic encephalopathy).

• Coexistence autoimmune hepatitis.

• Bilirrubin >3mg/dl.

• For females, pregnancy or breast-feeding.

• Hepatocellular carcinoma.

• History or presence of spontaneous bacterial peritonitis.