Status:
COMPLETED
Real-World Data Study to Evaluate the Effectiveness of OCA on Hepatic Outcomes in PBC Patients
Lead Sponsor:
Intercept Pharmaceuticals
Collaborating Sponsors:
Target RWE
Syneos Health
Conditions:
Primary Biliary Cholangitis
Eligibility:
All Genders
18+ years
Brief Summary
This is an observational, retrospective cohort study of patients with primary biliary cholangitis (PBC) who failed ursodeoxycholic acid (UDCA) treatment, using a real-world data source, the Komodo Hea...
Eligibility Criteria
Inclusion
- Key
- Definite or probable PBC diagnosis
- Inadequate response or intolerance to UDCA
- Age ≥18 years at the index date
- Continuous enrollment and evaluable data for at least 12 months before the index date (inclusive)
- Key
Exclusion
- History or presence of other concomitant liver diseases
- History of non-skin malignancy or melanoma
- History of HIV
- Medical conditions that may cause non-hepatic increases in ALP
- Patients with laboratory values indicative of hepatic decompensation or significant hepatobiliary injury
- History of liver transplant
- Evidence of fenofibrate, or bezafibrate use
- History or presence of hepatic decompensating events
Key Trial Info
Start Date :
June 1 2015
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 31 2021
Estimated Enrollment :
4577 Patients enrolled
Trial Details
Trial ID
NCT05292872
Start Date
June 1 2015
End Date
December 31 2021
Last Update
January 24 2025
Active Locations (1)
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1
Intercept Pharmaceuticals, Inc
San Diego, California, United States, 92121