Clinical Research of Tapering Ursodeoxycholic Acid in Primary Biliary Cholangitis Patients With A Complete Response

Who is this study for? Adult patients with primary biliary cholangitis
What treatments are being studied? Ursodeoxycholic acid
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
China
Peking Union Medical College Hospital
RECRUITING
Beijing
Contact Information
Primary
Li Wang
wangli2221@sina.com
8613801175089
Time Frame
Start Date: 2020-01-21
Estimated Completion Date: 2025-05
Participants
Target number of participants: 90
Treatments
Experimental: 10mg/Kg UDCA
Patients will receive a reduced dosage of 10mg/Kg UDCA orally everyday.
Experimental: 5mg/Kg UDCA
Patients will receive a reduced dosage of 5mg/Kg UDCA orally everyday.
Active_comparator: standard 13-15mg/Kg UDCA
Patients will receive standard dosage of 13-15mg/Kg UDCA everyday.
Sponsors
Leads: Peking Union Medical College Hospital

This content was sourced from clinicaltrials.gov