None listed
Conditions
Brief summary
Currently, we don't know enough about how PBC affects people in Australia, or if everyone is getting the very best care. Doctors also want to understand how new and existing treatments are working in real life. This project will help us gather important information to: • Improve care: Make sure people with PBC get the best possible care. • Understand treatments: See how different medicines are working and if there are better ways to use them. • Spot problems: Identify any areas where care can be improved for people with PBC. • Help the future: This information will help doctors, hospitals, and even the government make better decisions about PBC care.
Interventions
No direct patient involvement, this study is collecting data both retrospectively and prospectively from patient records including investigation results.
Data on hospital out-patient and in-patient visits will be recorded (when relevant to PBC) as well as treatments prescribed including dose and timing and date of initiation and cessation. There is no requirement for participants to complete any additional questionnaires or other physical assessment beyond that decided by the treating clinician
No direct patient involvement, this study is collecting data both retrospectively and prospectively from patient records including investigation results. Data on hospital out-patient and in-patient visits will be recorded (when relevant to PBC) as well as treatments prescribed including dose and timing and date of initiation and cessation. There is no requirement for participants to complete any additional questionnaires or other physical assessment beyond that decided by the treating clinician as part of usual or best practice care. The initial period of observation for the prospective cohort will be 5 years contingent on a satisfactory report to the ethics committee after 2 years. The retrospective data will be from medical records including clinical notes and pathology systems to insure that patients fulfil the inclusion criteria for PBC and to establish date of diagnosis, stage of disease and past therapies employed. Patients with PBC seen in the preceding 13 months to site initiation will be included in the retrospective cohort.
Sponsors
Bayside Health (Alfred Hospital)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
• Adults (greater or equal to 18 years of age) with a confirmed diagnosis of PBC according to internationally accepted criteria: • Positive anti-mitochondrial antibody (AMA), OR • Positive disease-specific antinuclear antibodies (gp210, sp100, PML, M2), OR • Characteristic liver histology in AMA-negative disease AND • Elevated ALP of 1.5 × ULN (upper limit of normal) on at least two occasions >3 months apart.
Exclusion criteria
• Overlap syndromes (PBC–AIH overlap, PSC–AIH overlap). • Prior liver transplant (unless included for quality-of-care evaluation in transplant clinics, analysed separately). • Insufficient medical record documentation (<6 months follow-up).
Outcome results
None listed