Actively Recruiting
Clinical Research of Tapering Ursodeoxycholic Acid in Primary Biliary Cholangitis Patients With A Complete Response
Led by Peking Union Medical College Hospital · Updated on 2025-04-01
90
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Primary biliary cholangitis (PBC) is a chronic autoimmune liver disease that causes progressive bile duct damage leading to liver fibrosis and cirrhosis if untreated. This research aims to explore whether lowering the dosage of ursodeoxycholic acid (UDCA), the main treatment for PBC in China, is feasible for patients with a complete response to standard treatment. The study involves patients who have shown improved liver function after UDCA treatment and seeks to understand the effects of reduced dosing on disease recurrence and patient health. Participants will be randomly assigned to one of three groups: two experimental groups receiving reduced UDCA doses of 10 mg/kg and 5 mg/kg daily, and a control group receiving the standard dose of 13-15 mg/kg daily. Treatment will last for at least one year, with evaluations every three months. These evaluations include symptom assessment, quality of life, liver function tests, blood and urine tests, immune markers, liver imaging, and tests of immune cells and cytokines. During the study, participants will undergo regular monitoring every three months to check for changes in symptoms, liver condition, and biochemical markers. The main outcome measured is the recurrence rate of PBC from baseline to months 3, 6, 9, and 12. This thorough follow-up helps researchers assess the safety and effects of reducing UDCA dosage, while participants continue to be monitored closely throughout the one-year study period.
CONDITIONS
Brief 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 criteria (2000)
- 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, normal bilirubin) after 6 to 12 months of UDCA treatment
- Provided informed consent
You will not qualify if you...
- Having other liver diseases such as hepatitis B, hepatitis C, or alcoholic cirrhosis, or ALT/AST more than twice the upper limit
- Decompensated liver function (Child grade B or C)
- Serious organ failure (e.g., kidney), infections, or other severe complications
- Pregnancy, planning 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
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - At least 1 year
Participants receive daily ursodeoxycholic acid (UDCA) at either standard or reduced dosages for at least one year to manage primary biliary cholangitis.
Visits every 3 months for assessments
Trial Site Locations
Total: 1 location
1
Peking Union Medical College Hospital
Beijing, China
Actively Recruiting
Research Team
L
Li Wang
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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