Real-World Data Study to Evaluate the Effectiveness of OCA on Hepatic Outcomes in PBC Patients

Primary Biliary Cholangitis Clinical Trial

— HEROES PBC  

Official title:

Replicate Studies Evaluating the Effectiveness of Obeticholic Acid on Hepatic Real-World Outcomes in Patients With Primary Biliary Cholangitis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05292872
• Other study ID #: 747-405
• Status: Completed
• Start date: March 28, 2022
• Est. completion date: July 15, 2022

Study information

• Verified date: July 2022
• Source: Intercept Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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 will be considered for this study.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Cholangitis
• Liver Cirrhosis, Biliary
• Primary Biliary Cholangitis

Intervention

Drug:
• Obeticholic Acid 5 MG
once daily, oral administration
• Obeticholic Acid 10 MG
once daily, oral administration
• Standard of Care: UDCA
No study medication is provided by the sponsor or by the investigators. The decision to initiate, continue or discontinue UDCA, or to modify UDCA dosing, is entirely at the discretion of the treating physician as per their standard of care and is in no way influenced by the sponsor or participating institutions. UDCA utilization is recorded and included in the study record.

Locations

Country	Name	City	State
United States	Intercept Pharmaceuticals, Inc	San Diego	California

Sponsors (5)

Lead Sponsor	Collaborator
Intercept Pharmaceuticals	Global PBC Study Group, Syneos Health, Target RWE, UK PBC Group

Country where clinical trial is conducted

United States, 

Outcome

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.