Study of OCA in Combination With BZF Evaluating Efficacy, Safety and Tolerability in Patients With PBC

• Status: Recruiting
• Trial end date: 2023-12-01
• Target enrollment: 0
• Participant gender: All

Summary

Study to determine the effect of the investigational drug bezafibrate (BZF) alone and in combination with the investigational drug obeticholic acid (also known as OCA) in patients with Primary Biliary Cholangitis (also known as PBC).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Intercept Pharmaceuticals
• Treatments: Bezafibrate; Chenodeoxycholic Acid

Criteria

Inclusion Criteria:

• A definite or probable diagnosis of PBC

• Qualifying ALP and/or bilirubin liver biochemistry values

• Taking ursodeoxycholic acid (UDCA) for at least 12 months or no UDCA for 3 months before Day 1

Exclusion Criteria:

• History or presence of other concomitant liver diseases

• Presence of clinical complications of PBC

• History or presence of decompensating events

• Current or history of gallbladder disease

• If female, known pregnancy, or has a positive urine pregnancy test (confirmed by a positive serum pregnancy test), or lactating

• Treatment with commercially available OCA or participation in a previous study involving OCA within 3 months before Screening

• Treatment with commercially available fibrates, or participation in a previous study involving fibrate within 3 months before Screening