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NCT05292872 · ClinicalTrials.gov registry record
Real-World Data Study to Evaluate the Effectiveness of OCA on Hepatic Outcomes in PBC Patients
A clinical trial, sponsored by Intercept Pharmaceuticals.
- Completed
- Registry status
- 4,577
- Enrollment target
NCT05292872: Completed study, sponsored by Intercept Pharmaceuticals.
NCT05292872 is a clinical trial that has completed, run by Intercept Pharmaceuticals. The registered enrollment target is 4,577 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05292872 has completed, sponsored by Intercept Pharmaceuticals.
- COMPLETED
- Registry status
- 4,577 participants
- Enrollment target
Study 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.
Primary Outcome
The primary analysis outcome was assessed with hazard ratio (HR) comparing hazard of first event of the composite endpoint among OCA-treated participants and SMR-weighted non-OCA-treated PBC participants indexes. It included all-cause death, liver transplant, hospitalization for hepatic decompensation based on first occurrence of: variceal bleed, ascites (including hepatic hydrothorax and spontaneous bacterial peritonitis) and hepatic encephalopathy. OCA-treated indexes were censored 90 days aft
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 4,577 participants |
| Start Date | 2015-06-01 |
| Est. Completion | 2021-12-31 |
What the finished NCT05292872 record still lists
NCT05292872 is an observational study that tracks outcomes without assigning an intervention. Its 4,577 participants enrollment target places it among the larger protocols in the corpus.
The record links to 0 conditions, and to 0 interventions.
NCT05292872 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05292872 about?
NCT05292872 is a clinical study titled "Real-World Data Study to Evaluate the Effectiveness of OCA on Hepatic Outcomes in PBC Patients". 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 obeti...
What is the current status of trial NCT05292872?
This trial is currently completed. The enrollment target is 4,577 participants. The study started on 2015-06-01. Estimated completion is 2021-12-31.
Who is sponsoring clinical trial NCT05292872?
This trial is sponsored by Intercept Pharmaceuticals, which has 18 total clinical trials registered on ClinicalTrials.gov.
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