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

Intercept Pharmaceuticals

Status: Completed

Conditions: Primary Biliary Cholangitis

Treatments: Drug: Standard of Care: UDCA; Drug: Obeticholic Acid 10 MG; Drug: Obeticholic Acid 5 MG

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT05292872

747-405

Details and patient eligibility

About

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.

Enrollment: 4,577 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Key Inclusion Criteria:

1. Definite or probable PBC diagnosis
2. Inadequate response or intolerance to UDCA
3. Age ≥18 years at the index date
4. Continuous enrollment and 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. History of non-skin malignancy or melanoma
3. History of HIV
4. Medical conditions that may cause non-hepatic increases in ALP
5. Patients with laboratory values indicative of hepatic decompensation or significant hepatobiliary injury
6. History of liver transplant
7. Evidence of fenofibrate, or bezafibrate use
8. History or presence of hepatic decompensating events

Trial design

4,577 participants in 2 patient groups

OCA-treated

Description:

PBC participants with a history of UDCA failure (inadequate response, intolerance, or discontinuation) who initiated Obeticholic acid (OCA) in the study window.

Non-OCA Treated

Description:

PBC participants with a history of UDCA failure who were eligible but not treated with OCA (or off-label fibrates) in the study window.