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

Summary

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.

Eligibility

Inclusion Criteria:

* 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 Criteria:

* 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.

Conditions2

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