Clinical Research of Tapering UDCA in PBC Patients With a Complete Response

Recruiting now · Phase 4

Conditions studied: Primary Biliary Cholangitis

In brief

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.

Key facts

Study ID: NCT04650243
Run by: Peking Union Medical College Hospital
People needed: 90
Starts: 2020-01-21
Expected to finish: 2025-05-01
Last updated by the study team: 2025-04-01

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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.

You may not qualify if…

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);
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.;
Participating in other clinical trials or participated in other clinical trials in three months.

Where it is running

Peking Union Medical College Hospital — Beijing, China (enrolling)

Full record on ClinicalTrials.gov

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