Clinical Research of Tapering UDCA in PBC Patients With a Complete Response
ConditionPrimary Biliary Cholangitis
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorPeking Union Medical College Hospital
About this trial
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.
Eligibility criteria
Qualifiers
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;
Disqualifiers
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.;
Trial design
Treatments tested in this trial
- ursodeoxycholic acid
Treatment groups
90 Participants
are divided into 3 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov