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

Instituto Mexicano del Seguro Social

Status and phase: Unknown; Phase 3

Conditions: Primary Biliary Cirrhosis

Treatments: Drug: Placebo; Drug: Bezafibrate 200 MG Oral Tablet; Drug: Ursodeoxycholic Acid

Study type: Interventional

Funder types: Other

Identifiers

NCT04751188

R-2020-2101-031

Details and patient eligibility

About

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.

Enrollment: 11 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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11 participants in 2 patient groups, including a placebo group

Bezafibrate and Ursodeoxycholic acid

Experimental group

Description:

Bezafibrate 200 mg every 12 hours and ursodeoxycholic acid at a dose of 13 to 15 mg per Kg per day, for 6 months.

Treatment:

Drug: Ursodeoxycholic Acid

Drug: Bezafibrate 200 MG Oral Tablet

Placebo and Ursodeoxycholic acid

Placebo Comparator group

Description:

Placebo tablet every 12 hours and ursodeoxycholic acid at a dose of 13 to 15 mg per Kg per day, for 6 months.

Treatment:

Drug: Ursodeoxycholic Acid

Drug: Placebo