Status:
WITHDRAWN
A Real-World Data Study to Evaluate the Effectiveness of OCA on Hepatic Outcomes in PBC Patients
Lead Sponsor:
Intercept Pharmaceuticals
Collaborating Sponsors:
Global PBC Study Group
Target RWE
Conditions:
Primary Biliary Cholangitis
Eligibility:
All Genders
18+ years
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 tre...
Eligibility Criteria
Inclusion
- Key
- Definite or probable PBC diagnosis
- UDCA failure
- Age ≥18 years at the index date
- Evaluable data for at least 12 months before the index date (inclusive)
- Key
Exclusion
- History or presence of other concomitant liver diseases
- Patients with laboratory values indicative of hepatic decompensation or significant hepatobiliary injury
- History of liver transplant
- Evidence of OCA, fenofibrate, or bezafibrate use
- History or presence of hepatic decompensating events
- Participation in a clinical trial for a PBC medication
Key Trial Info
Start Date :
March 28 2022
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
July 1 2023
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT05293938
Start Date
March 28 2022
End Date
July 1 2023
Last Update
October 10 2023
Active Locations (1)
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1
Intercept Pharmaceuticals, Inc
San Diego, California, United States, 92129