Clinical Research of Reducing Medication Regimen for Ursodeoxycholic Acid in Treatment of Stable Primary Biliary Cholangitis

• Status: Recruiting
• Trial end date: 2024-10-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Peking Union Medical College Hospital
• Treatments: Ursodeoxycholic Acid

Criteria

Inclusion Criteria:

• Satisfied the diagnostic criteria of PBC by the AASLDin 2000;

• Aged 18-65 years old;

• Clinical stage 2 and 3 (i.e. abnormal liver function and symptomatic phase);

• Patients with improved liver biochemical index(i.e. bilirubin≤17μmol/L, ALP≤3ULN, and AST≤2ULN) for at least 6 months 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);

• Combined with other autoimmune diseases;

• 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.;

• Combined with tumor;

• Participating in other clinical trials or participated in other clinical trials in three months.