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Clinical Trial Details — Status: Withdrawn

Administrative data

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Status Withdrawn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

Study information

Verified date October 2023
Source Intercept Pharmaceuticals
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Withdrawn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

Study Design


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 Study 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 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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