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

Intercept Pharmaceuticals

Overview

This is an observational, retrospective cohort study, using the UK PBC registry, comparing patients with primary biliary cholangitis (PBC) who failed ursodeoxycholic acid (UDCA) treatment and were treated with obeticholic acid (OCA) to patients with PBC who failed UDCA treatment and were not treated with second-line therapy. The study is designed to evaluate the effectiveness of 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 will be considered for this study.

Study Type

OBSERVATIONAL

Conditions

Primary Biliary Cholangitis

Interventions

Obeticholic Acid 5 MGDRUG

once daily, oral administration

Obeticholic Acid 10 MGDRUG

once daily, oral administration

Standard of Care: UDCADRUG

No study medication is provided by the sponsor or by the investigators. The decision to initiate, continue or discontinue UDCA, or to modify UDCA dosing, is entirely at the discretion of the treating physician as per their standard of care and is in no way influenced by the sponsor or participating institutions. UDCA utilization is recorded and included in the study record.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Key Inclusion Criteria: 1. Definite or probable PBC diagnosis 2. UDCA failure 3. Age ≥18 years at the index date 4. Evaluable data for at least 12 months before the index date (inclusive) Key Exclusion Criteria: 1. History or presence of other concomitant liver diseases 2. Patients with laboratory values indicative of hepatic decompensation or significant hepatobiliary injury 3. History of liver transplant 4. Evidence of OCA, fenofibrate, or bezafibrate use 5. History or presence of hepatic decompensating events 6. Participation in a clinical trial for a PBC medication

Locations (1)

Intercept Pharmaceuticals, Inc

San Diego, California, United States

Outcomes

Primary Outcomes

Time to the first occurrence of the composite endpoint of all-cause death, liver transplant, or hepatic decompensation.

Time frame: Time from index date to first occurrence of the composite endpoint events, assessed up to 62 months.

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.