Clinical trial
Study Evaluating the Effectiveness of Obeticholic Acid on Hepatic Real-World Outcomes in Patients With Primary Biliary Cholangitis
Name
747-404
Description
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.
Trial arms
Trial start
2022-03-28
Estimated PCD
2023-06-01
Trial end
2023-07-01
Status
Withdrawn
Treatment
Obeticholic Acid 5 MG
once daily, oral administration
Arms:
OCA Treatment Group
Other names:
Ocaliva
Obeticholic Acid 10 MG
once daily, oral administration
Arms:
OCA Treatment Group
Other names:
Ocaliva
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.
Arms:
Control Group
Primary endpoint
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.
Eligibility 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
Protocol
{'studyType': 'OBSERVATIONAL', 'patientRegistry': False, 'designInfo': {'observationalModel': 'COHORT', 'timePerspective': 'RETROSPECTIVE'}, 'enrollmentInfo': {'count': 0, 'type': 'ACTUAL'}}
Updated at
2023-10-10
1 organization
2 products
1 indication
Organization
Intercept PharmaceuticalsProduct
Obeticholic AcidIndication
Primary Biliary CholangitisProduct
UDCA