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

WithdrawnOBSERVATIONAL
0
Timeline

Start Date

March 28, 2022

Primary Completion Date

June 30, 2023

Study Completion Date

July 31, 2023

Conditions
Primary Biliary Cholangitis
Interventions
DRUG

Obeticholic Acid 5 MG

once daily, oral administration

DRUG

Obeticholic Acid 10 MG

once daily, oral administration

DRUG

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.

Trial Locations (1)

92129

Intercept Pharmaceuticals, Inc, San Diego

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Global PBC Study Group

UNKNOWN

collaborator

Target RWE

INDUSTRY

collaborator

Syneos Health

OTHER

collaborator

UK PBC Study Group

UNKNOWN

lead

Intercept Pharmaceuticals

INDUSTRY