Reducing medication regimen for UDCA in PBC patients

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

This study is testing if lowering the dose of a medication called UDCA can still help people with Primary Biliary Cholangitis who are doing well on their current treatment.

Quick facts

• Phase: Phase 4
• Study type: Interventional
• Enrollment: 90 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Peking Union Medical College Hospital (Academic / other)
• Locations: 1 site (Beijing)
• Trial ID: NCT04650243 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with diagnosed PBC who have shown improved liver biochemical indices after initial UDCA treatment.

Not a fit: Patients with overlapping liver diseases, decompensated liver function, or serious complications may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a more cost-effective treatment regimen for PBC patients without compromising their liver function.

How similar studies have performed: While there have been studies on UDCA treatment, this specific approach of tapering dosage in stable PBC patients is novel and has not been extensively tested.

Eligibility criteria

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 this trial is running

Beijing

• Peking Union Medical College Hospital — Beijing, China (Recruiting)

Study contacts

• Study coordinator: Li Wang

Conditions Primary Biliary Cholangitis; ursodeoxycholic acid; reducing medication regimen