Actively Recruiting
Clinical Research of Tapering UDCA in PBC Patients With a Complete Response
Led by Peking Union Medical College Hospital · Updated on 2025-04-01
90
Participants Needed
1
Research Sites
275 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Clinical Research of Tapering UDCA in PBC Patients With a Complete Response
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosed with primary biliary cholangitis according to AASLD 2000 criteria
- Age 18 years or older
- Clinical stage 2 or 3 with abnormal liver function and symptoms
- Improved liver biochemical markers (ALP and AST ≤1.5 times upper limit of normal, normal bilirubin) after 6 to 12 months of UDCA treatment
- Provided informed consent
You will not qualify if you...
- Other liver diseases present (such as HBV, HCV, alcoholic cirrhosis) or ALT/AST more than twice the upper limit of normal
- Liver function decompensation (Child grade B or C)
- Serious organ failure, serious infection, or other severe complications
- Pregnancy, preparing for pregnancy, breastfeeding, or psychiatric conditions
- Participation in other clinical trials currently or within the past three months
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Peking Union Medical College Hospital
Beijing, China
Actively Recruiting
Research Team
L
Li Wang
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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