At a glance
ClinicalIndex Comparison RecordN/ACompleted· 4,577 enrolled
Drug / intervention
Not specified
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Replicate Studies Evaluating the Effectiveness of Obeticholic Acid on Hepatic Real-World Outcomes in Patients With Primary Biliary Cholangitis
In Brief
An observational study for Primary Biliary Cholangitis. Completed, enrolled 4,577 participants across 1 site.
Detailed 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 Health United States (US) claims database. The study is designed to evaluate the effectiveness of obeticholic acid (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 were considered for this study.
Study Details
Study Typeobservational
Allocation--
Masking--
Primary Purpose--
ConditionsPrimary Biliary Cholangitis
CountriesUnited States
CollaboratorsTarget RWE, Syneos Health, Komodo Health, Inc.
Timeline
N/ACompletedFinished
20162017201820192020202120222023202420252026
Enrollment StartJun 2015
Primary CompletionDec 2021
First PostedMar 2022
TodayJul 2026
First PostedMar 23, 2022
Enrollment StartJun 1, 2015
Primary CompletionDec 31, 2021
TodayJul 2, 2026
Enrollment to primary: 6.6 yearsPosted 4.3 years ago