NCT05450887View on ClinicalTrials.gov

Efficacy and Safety of Obeticholic Acid in the Treatment of Primary Biliary Cholangitis

PHASE3CompletedINTERVENTIONAL
Enrollment

108

Participants

Timeline

Start Date

September 23, 2021

Primary Completion Date

March 18, 2024

Study Completion Date

April 9, 2024

Conditions
Primary Biliary Cholangitis
Interventions
DRUG

Obeticholic Acid Tablets（OCA）

Obeticholic Acid：Once a day (QD) by mouth (PO).

DRUG

UDCA

UDCA：13\~15 mg/kg/day

DRUG

Placebo

Placebo：Once a day (QD) by mouth (PO).

Trial Locations (1)

100050

Beijing Friendship Hospital, Beijing

Sponsors
All Listed Sponsors
lead

Nanjing Chia-tai Tianqing Pharmaceutical

INDUSTRY