National Database on Primary Biliary Cholangitis
ConditionPrimary Biliary Cholangitis
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversity of Milano Bicocca
About this trial
Primary biliary cholangitis (PBC) is a rare, autoimmune, cholestatic liver disease. No data about the disease epidemiology exist in Italy. Therefore this study aims to develop a national PBC patient database linked to a biological sample storage.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
elevated alkaline phosphatase and /or GGT;
positive anti-mitochondrial autoantibodies (titer ≥ 1:40) or PBC-specific antinuclear antibodies (gp-210 and sp100);
characteristic histological features of florid bile ducts lesions and granulomatous lesion.
Disqualifiers
None
Trial population
All the italian patients fulfilling the diagnostic criteria for Primary Biliary Cholangitis (European Association for the Study of the Liver. EASL Clinical Practice Guidelines: management of cholestatic liver diseases. J Hepatol. 2009 Aug;51(2):237-67) and aged at least 18.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Clinical information
Other interventionThe investigators will recruit PBC patients and collect important clinical information and laboratory investigation, together with biological samples.
Treatment groups
6,000 Participants
are divided into 1 treatment groupGroup A: PBC population residing in Italy1 intervention
Trial outcomes
Primary outcomes
1
Phenotypes and sub-phenotypes of PBC Italian patients
Identify and define distinct phenotypes and sub-phenotypes of PBC patients at higher risk of disease progression.
Time frame
Overall duration of the study (10 years)Secondary outcomes
1
Response to UDCA therapy
Defined as Alkaline Phosphatase Level\<1 x upper limit of normal. The investigators will fit a multivariate analysis using logistic regression using baseline variables.
Time frame
Overall duration of the study (10 years)2
Identification of factors influencing the progression of PBC
The investigators will calculate the time from the diagnosis of PBC to an event (liver decompensation, liver transplantation or death). They will then fit a multivariate analysis using Cox's proportional hazards regression model of diverse explanatory variables available at baseline.
Time frame
Overall duration of the study (10 years)3
Safety and long-term efficacy of novel therapies
The investigators will evaluate prospectively laboratory investigation and the treatment response to novel therapies that are entering the clinical practice, e.g. obeticholic acid, fibrates.
Time frame
Overall duration of the study (10 years)Sponsors and contacts
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Source ClinicalTrials.gov