Trials / Completed
CompletedNCT05450887
Efficacy and Safety of Obeticholic Acid in the Treatment of Primary Biliary Cholangitis
A Randomized, Double-blind, Multicenter, Placebo-controlled Phase III Clinical Trial to Evaluate the Efficacy and Safety of Obeticholic Acid in Patients With Primary Biliary Cholangitis
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 108 (actual)
- Sponsor
- Nanjing Chia-tai Tianqing Pharmaceutical · Industry
- Sex
- All
- Age
- 18 Years – 75 Years
- Healthy volunteers
- Not accepted
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
| Type | Name | Description |
|---|---|---|
| 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). |
Timeline
- Start date
- 2021-09-23
- Primary completion
- 2024-03-18
- Completion
- 2024-04-09
- First posted
- 2022-07-11
- Last updated
- 2024-07-11
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT05450887. Inclusion in this directory is not an endorsement.