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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
ursodeoxycholic acid
DrugThe two experimental groups will receive reduced dosage of UDCA at 10mg/Kg and 5mg/Kg everyday respectively, while the control group will receive standard dosage of UDCA.The treatment duration will be at least one year.
Treatment groups
90 Participants
are divided into 3 treatment groupsGroup A: 10mg/Kg UDCAExperimental treatment 1 intervention
Group B: 5mg/Kg UDCAExperimental treatment 1 intervention
Group C: standard 13-15mg/Kg UDCAActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Recurrence rate of primary biliary cholangitis
Liver biochemical markers (AST and ALP in U/L, TBIL in umol/L) that restored to normal increase(bilirubin\>1xULN,ALP≥1.5X ULN, AST≥1.5XULN) again is considered to be PBC recurrence according to the Paris II criteria. The rate of recurrence will be described in percent.
Time frame
change from baseline to month3,6,9,12.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov