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

NCT05450887 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 108

Last updated 2024-07-11

No results posted yet for this study

Summary

Obecholic acid is a modified bile acid and Farnesoid X receptor (FXR) agonist. FXR is a key regulator of bile acid synthesis and transport. Bile acids are used by the body to help with digestion. Conventional therapy with obecholic acid will improve liver function of patients with (primary biliary cholangitis)PBC.

The main objectives of the study were to assess the effects of Obeticholic Acid (OCA) on serum alkaline phosphatase (ALP) and total bilirubin, together as a composite endpoint and on safety in participants with PBC.

Conditions

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).

Sponsors & Collaborators

  • Nanjing Chia-tai Tianqing Pharmaceutical

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-09-23
Primary Completion
2024-03-18
Completion
2024-04-09

Countries

  • China

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05450887 on ClinicalTrials.gov