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

Intercept Pharmaceuticals

Status: Withdrawn

Conditions: Primary Biliary Cholangitis

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

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT05293938

747-404

Details and patient eligibility

About

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.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

0 participants in 2 patient groups

OCA Treatment Group

Description:

PBC patients with a history of UDCA failure who initiated OCA in the study window (01 Jun 2015 to 31 Dec 2021)

Treatment:

Drug: Obeticholic Acid 10 MG

Drug: Obeticholic Acid 5 MG

Control Group

Description:

PBC patients with a history of UDCA failure who were eligible but were not treated with OCA (or off-label fibrates) in the study window (01 Jun 2015 to 31 Dec 2021)

Treatment:

Drug: Standard of Care: UDCA