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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Study Classification

OBSERVATIONAL

Study Start Date

2022-03-28

Study Completion Date

2023-07-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Primary Biliary Cholangitis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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OCA Treatment Group

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

Obeticholic Acid 5 MG

Intervention Type DRUG

once daily, oral administration

Obeticholic Acid 10 MG

Intervention Type DRUG

once daily, oral administration

Control Group

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)

Standard of Care: UDCA

Intervention Type DRUG

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.

Interventions

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Obeticholic Acid 5 MG

once daily, oral administration

Intervention Type DRUG

Obeticholic Acid 10 MG

once daily, oral administration

Intervention Type DRUG

Standard 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.

Intervention Type DRUG

Other Intervention Names

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Ocaliva Ocaliva

Eligibility Criteria

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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)

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No