Reducing medication regimen for UDCA in PBC patients

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study investigates the feasibility of tapering the dosage of Ursodeoxycholic Acid (UDCA) in patients with Primary Biliary Cholangitis (PBC) who have shown a complete response to standard treatment. Participants will be randomly assigned to two experimental groups receiving reduced dosages of UDCA and one control group receiving the standard dosage. The effects of the therapy will be monitored every three months to assess liver function and overall health outcomes. This approach aims to alleviate the financial burden of lifelong medication while maintaining treatment efficacy.

Why it matters

Who can join: the full rules

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.

Where it's running

• Peking Union Medical College Hospital
  Beijing, China Recruiting

Study contacts

• Study coordinator: Li Wang
• Email: wangli2221@sina.com
• Phone: 8613801175089

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Biochemical response and health outcomes in people with primary biliary cholangitis

  We will follow adults with primary biliary cholangitis who are taking ursodeoxycholic acid (UDCA) to see if their alkaline phosphatase levels after treatment predict how long they stay free of complications.

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• Saroglitazar Magnesium for PBC with incomplete UDCA response or intolerance

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• CS0159 for primary biliary cholangitis when UDCA doesn't work or isn't tolerated.

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• Saroglitazar Magnesium-V as add-on therapy for primary biliary cholangitis

  This trial tests whether Saroglitazar Magnesium-V, compared with placebo, can improve long-term clinical outcomes in adults with primary biliary cholangitis who are on UDCA.

  Recruiting at 3 sites Phase 3 Zydus Therapeutics Inc. · Marietta, Georgia and 2 other locations · NCT07216235

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.