Testing lower doses of ursodeoxycholic acid in primary biliary cholangitis
Tests whether lower doses of ursodeoxycholic acid work in adults with primary biliary cholangitis.
Plain-language title generated from the registry record
Registry title: Clinical Research of Tapering UDCA in PBC Patients With a Complete Response
Key facts
- Where
- Beijing, ChinaSee the site
- Phase
- Phase 4
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with primary biliary cholangitis (PBC) whose liver tests improved after 6 to 12 months of treatment with ursodeoxycholic acid (UDCA). It tests lower doses of UDCA.
- Age
- 18 years or older
- Sex
- All sexes can join.
- Disease stage
- Clinical stage 2 or 3 of PBC (abnormal liver function and symptoms).
- Earlier treatment
- Must have taken UDCA for 6 to 12 months, with improved liver tests (ALP and AST at or below 1.5 times the upper limit of normal, normal bilirubin).
Main reasons for not taking part
- Other liver diseases (such as HBV, HCV, alcoholic cirrhosis) or ALT or AST more than 2 times the upper limit of normal
- Liver function not compensated (Child grade B/C)
- Failure of an important organ (such as renal insufficiency), serious infection or other serious complications
- Pregnancy, planning pregnancy, breastfeeding, or psychiatric conditions
- In another clinical trial now or in the last three months
Read by machine on 9 November 2026.
Where in China
- Peking Union Medical College HospitalBeijing, ChinaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Peking Union Medical College Hospital
- Trial code
- NCT04650243
- Record updated
- 1 April 2025
- Original description
This study explores the feasibility of the reducing medication regimen for Ursodeoxycholic Acid(UDCA) in the treatment of primary biliary cholangitis. The participants will be distributed randomly into two experimental groups and one control group. The two experimental groups will receive reduced dosage of UDCA at different level, while the control group will receive standard dosage of UDCA. The effect of therapy will be evaluated every three months.Read full original descriptionShow less
Clinical Research of Tapering Ursodeoxycholic Acid in Primary Biliary Cholangitis Patients With A Complete Response
This study explores the feasibility of the reducing medication regimen for Ursodeoxycholic Acid(UDCA) in the treatment of primary biliary cholangitis. The participants will be distributed randomly into two experimental groups and one control group. The two experimental groups will receive reduced dosage of UDCA at different level, while the control group will receive standard dosage of UDCA. The effect of therapy will be evaluated every three months.
Inclusion: Satisfied the diagnostic criteria of PBC by the AASLDin 2000; Age≥18 years; Clinical stage 2 and 3 (i.e. abnormal liver function and symptomatic phase); Patients with improved liver biochemical index( ALP and AST≤1.5× upper limit of normal, with a normal bilirubin level) after 6 to 12 months treatment of UDCA; Informed consent obtained.
Exclusion: Complicated with important organ failure (such as renal insufficiency), serious infection or other serious complications; Pregnancy, preparation for pregnancy or pregnancy Lactation, psychiatric subjects, etc; Overlapped with other liver diseases (such as HBV, HCV, alcoholic cirrhosis, etc.) or serum ALT, AST more than 2 ULN; Decompensation of liver function (Child grade B/C); Participating in other clinical trials or participated in other clinical trials in three months.