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

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

Status

Withdrawn

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05293938

Acronym

HEROES-PBC

Enrollment

Registered

2022-03-24

Start date

2022-03-28

Completion date

2023-07-31

Last updated

2023-10-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Primary Biliary Cholangitis

Keywords

Primary Biliary Cholangitis, Primary Biliary Cirrhosis, PBC, Hepatic Impairment, Liver

Brief summary

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.

Interventions

DRUGStandard of Care: UDCA

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.

DRUGObeticholic Acid 5 MG

once daily, oral administration

DRUGObeticholic Acid 10 MG

once daily, oral administration

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion 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

Design outcomes

Primary

Measure	Time frame
Time to the first occurrence of the composite endpoint of all-cause death, liver transplant, or hepatic decompensation.	Time from index date to first occurrence of the composite endpoint events, assessed up to 62 months.

Other

Measure	Time frame
Time to the first occurrence of all-cause death	Time from index date to first occurrence of all-cause death, assessed up to 62 months.
Time to the first occurrence of liver transplant	Time from index date to first occurrence of liver transplant, assessed up to 62 months.
Time to first occurrence of hepatic decompensation	Time from index date to first occurrence of hospitalization for hepatic decompensation, assessed up to 62 months.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026