Trials / Unknown
UnknownNCT04956328
Study of Obeticholic Acid（OCA） Combination With Ursodeoxycholic Acid (UDCA) in Patients With Primay Biliary Cirrhosis (PBC)
A Multi-center, Randomized, Double-blind Trail Evaluating the Efficacy and Safety of Combination of Obecholic Acid and UDCA Compared With UDCA Monotherapy in PBC Patients With an Inadequate Response to UDCA .
- Status
- Unknown
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 120 (estimated)
- Sponsor
- Chia Tai Tianqing Pharmaceutical Group Co., Ltd. · 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 PBC.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Obeticholic Acid Tablets | Obeticholic Acid：Once a day (QD) by mouth (PO). |
| DRUG | UDCA | UDCA：continue prestudy dose |
| DRUG | Placebo | Placebo |
Timeline
- Start date
- 2021-07-22
- Primary completion
- 2023-09-20
- Completion
- 2023-09-20
- First posted
- 2021-07-09
- Last updated
- 2021-07-26
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT04956328. Inclusion in this directory is not an endorsement.