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

Withdrawn

• Conditions: Primary Biliary Cholangitis
• Interventions: Drug: Obeticholic Acid 5 MG; Drug: Obeticholic Acid 10 MG

• Registration Number: NCT05293938
• Lead Sponsor: Intercept Pharmaceuticals

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-03-04
• Study First Submitted QC: 2022-03-14
• Study First Posted: 2022-03-24
• Study Start: 2022-03-28
• Primary Completion: 2023-06
• Study Completion: 2023-07
• Status Verified: 2023-10
• Last Update Submitted: 2023-10-05
• Last Update Posted: 2023-10-10

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
OCA Treatment Group	Obeticholic Acid 5 MG	PBC patients with a history of UDCA failure who initiated OCA in the study window (01 Jun 2015 to 31 Dec 2021)
OCA Treatment Group	Obeticholic Acid 10 MG	PBC patients with a history of UDCA failure who initiated OCA in the study window (01 Jun 2015 to 31 Dec 2021)

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Intercept Pharmaceuticals, Inc; 🇺🇸 San Diego, California, United States