NCT04650243RecruitingPhase 4
Clinical Research of Tapering UDCA in PBC Patients With a Complete Response
Clinical Research of Tapering Ursodeoxycholic Acid in Primary Biliary Cholangitis Patients With A Complete Response
Source: ClinicalTrials.gov · Last updated 1 Apr 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 90 (estimated)
- First submitted
- 27 Apr 2020
- Start date
- 21 Jan 2020
- Primary completion date
- 31 May 2025
- Lead sponsor
- Peking Union Medical College Hospital
- Diseases
- Primary biliary cholangitis
- NCT number
- NCT04650243
What you commit to
- Study type: Interventional · Phase 4
- Planned participants: 90
- From 21 Jan 2020 to the primary completion date, 31 May 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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.;
Lab values
- Overlapped with other liver diseases (such as HBV, HCV, alcoholic cirrhosis, etc.) or serum ALT, AST more than 2 ULN;
Other
- Decompensation of liver function (Child grade B/C);
- Participating in other clinical trials or participated in other clinical trials in three months.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Peking Union Medical College Hospital Coordinator of this site? Confirm its status | Beijing | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.