NCT06715319View on ClinicalTrials.gov

Obeticholic Acid Versus Placebo, in Combination with Ursodeoxycholic Acid in Patients with Primary Biliary Cirrhosis

PHASE3CompletedINTERVENTIONAL

Enrollment

100

Participants

Timeline

Start Date

October 9, 2021

Primary Completion Date

October 16, 2023

Study Completion Date

April 29, 2024

Conditions

PBC

Interventions

DRUG

OCA

OCA 5 mg once daily in combination with UDCA for 12 weeks and then titrating up to 10 mg based on tolerability and response for remainder of double-blind period.

DRUG

UDCA

13\~15 mg/kg/day

DRUG

Placebo

Once a day (QD) by mouth (PO)

Trial Locations (1)

130021

The First Hospital of Jilin University, Changchun

All Listed Sponsors

lead

Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co., Ltd.

INDUSTRY

NCT06715319 - Obeticholic Acid Versus Placebo, in Combination with Ursodeoxycholic Acid in Patients with Primary Biliary Cirrhosis | Biotech Hunter | Biotech Hunter