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

NCT05293938 · Status: WITHDRAWN · Type: OBSERVATIONAL

Last updated 2023-10-10

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Obeticholic Acid 5 MG

once daily, oral administration

DRUG

Obeticholic Acid 10 MG

once daily, oral administration

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.

Sponsors & Collaborators

  • Global PBC Study Group

    collaborator UNKNOWN

  • Target RWE

    collaborator INDUSTRY

  • Syneos Health

    collaborator OTHER

  • UK PBC Study Group

    collaborator UNKNOWN

  • Intercept Pharmaceuticals

    lead INDUSTRY

Principal Investigators

  • Lynda Szczech, MD · Intercept Pharmaceuticals

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-03-28
Primary Completion
2023-06-30
Completion
2023-07-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05293938 on ClinicalTrials.gov