NCT05292872

Real-World Data Study to Evaluate the Effectiveness of OCA on Hepatic Outcomes in PBC Patients

Replicate Studies Evaluating the Effectiveness of Obeticholic Acid on Hepatic Real-World Outcomes in Patients With Primary Biliary Cholangitis

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 4,577 (actual)
• Sponsor: Intercept Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is an observational, retrospective cohort study of patients with primary biliary cholangitis (PBC) who failed ursodeoxycholic acid (UDCA) treatment, using a real-world data source, the Komodo Health United States (US) claims database. The study is designed to evaluate the effectiveness of obeticholic acid (OCA). All patients who meet diagnostic criteria for PBC in the database between 01 Jun 2015 and 31 Dec 2021 and who meet all eligibility criteria were considered for this study.

Conditions

• Primary Biliary Cholangitis

Timeline

• Start date: 2015-06-01
• Primary completion: 2021-12-31
• Completion: 2021-12-31
• First posted: 2022-03-23
• Last updated: 2025-01-24
• Results posted: 2025-01-24

Locations

1 site across 1 country: United States