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

NCT05292872 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 4577

Last updated 2025-01-24

Study results available
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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

Sponsors & Collaborators

  • Target RWE

    collaborator INDUSTRY

  • Syneos Health

    collaborator OTHER

  • Komodo Health, Inc.

    collaborator INDUSTRY

  • Intercept Pharmaceuticals

    lead INDUSTRY

Principal Investigators

  • Lynda Szczech, MD · Intercept Pharmaceuticals

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-06-01
Primary Completion
2021-12-31
Completion
2021-12-31

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05292872 on ClinicalTrials.gov