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

Launched by PEKING UNION MEDICAL COLLEGE HOSPITAL · Nov 30, 2020

Keywords

ClinConnect Summary

This clinical trial is investigating whether it is safe and effective to reduce the dosage of a medication called Ursodeoxycholic Acid (UDCA) for patients with Primary Biliary Cholangitis (PBC) who have shown a good response to treatment. Participants will be randomly assigned to one of three groups: two groups will receive lower doses of UDCA, while the third group will continue with the standard dose. Researchers will check how well the treatment is working every three months.

To participate, individuals must be at least 18 years old and have been diagnosed with PBC. They should also be in the second or third stage of the disease, meaning they have some liver function issues but have shown improvement in their liver tests after 6 to 12 months of UDCA treatment. It's important to note that people with other serious liver conditions, significant organ failures, or those who are pregnant or breastfeeding cannot join the study. This trial is currently looking for volunteers, and it aims to help improve treatment options for PBC patients.

Gender

ALL

Eligibility criteria

• 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.