Actively Recruiting

Phase 4
Age: 18Years +
All Genders
NCT04650243

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

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

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Trial Site Locations

Total: 1 location

1

Peking Union Medical College Hospital

Beijing, China

Actively Recruiting

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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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