Primary Biliary Cholangitis Clinical Trial
— HEROES-PBCOfficial title:
Study Evaluating the Effectiveness of Obeticholic Acid on Hepatic Real-World Outcomes in Patients With Primary Biliary Cholangitis
NCT number | NCT05293938 |
Other study ID # | 747-404 |
Secondary ID | |
Status | Withdrawn |
Phase | |
First received | |
Last updated | |
Start date | March 28, 2022 |
Est. completion date | July 2023 |
Verified date | October 2023 |
Source | Intercept Pharmaceuticals |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Withdrawn |
Enrollment | 0 |
Est. completion date | July 2023 |
Est. primary completion date | June 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | Intercept Pharmaceuticals, Inc | San Diego | California |
Lead Sponsor | Collaborator |
---|---|
Intercept Pharmaceuticals | Global PBC Study Group, Syneos Health, Target RWE, UK PBC Study Group |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Time to the first occurrence of all-cause death | Time from index date to first occurrence of all-cause death, assessed up to 62 months. | ||
Other | Time to the first occurrence of liver transplant | Time from index date to first occurrence of liver transplant, assessed up to 62 months. | ||
Other | Time to first occurrence of hepatic decompensation | Time from index date to first occurrence of hospitalization for hepatic decompensation, assessed up to 62 months. | ||
Primary | 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. |
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