Primary Biliary Cholangitis Clinical Trial
— HEROES PBCOfficial title:
Replicate Studies Evaluating the Effectiveness of Obeticholic Acid on Hepatic Real-World Outcomes in Patients With Primary Biliary Cholangitis
NCT number | NCT05292872 |
Other study ID # | 747-405 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | March 28, 2022 |
Est. completion date | July 15, 2022 |
Verified date | July 2022 |
Source | Intercept Pharmaceuticals |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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 will be considered for this study.
Status | Completed |
Enrollment | 4937 |
Est. completion date | July 15, 2022 |
Est. primary completion date | June 17, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Key Inclusion Criteria: 1. Definite or probable PBC diagnosis 2. Inadequate response or intolerance to UDCA 3. Age =18 years at the index date 4. Continuous enrollment and 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. History of non-skin malignancy or melanoma 3. History of HIV 4. Medical conditions that may cause non-hepatic increases in ALP 5. Patients with laboratory values indicative of hepatic decompensation or significant hepatobiliary injury 6. History of liver transplant 7. Evidence of fenofibrate, or bezafibrate use 8. History or presence of hepatic decompensating events |
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 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 67 months. | ||
Other | Time to the first occurrence of liver transplant | Time from index date to first occurrence of liver transplant, assessed up to 67 months. | ||
Other | Time to first occurrence of hospitalization for hepatic decompensation | Time from index date to first occurrence of hospitalization for hepatic decompensation, assessed up to 67 months. | ||
Primary | 1. Time to the first occurrence of the composite endpoint of all-cause death, liver transplant, or hospitalization for hepatic decompensation. | Time from index date to first occurrence of the composite endpoint events, assessed up to 67 months. |
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