K74.3
Conditions
Interventions
Group 1: Observational arm:
Retrospective analysis of patients with primary biliary cholangitis and liver cirrhosis who received elafibranor as part of routine clinical care.
No study-related interven
Sponsors
Universitätsmedizin Essen
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Confirmed diagnosis of primary biliary cholangitis according to current guidelines. Treatment with elafibranor as part of routine clinical care. Availability of at least one valid liver stiffness measurement obtained by vibration-controlled transient elastography (VCTE) and corresponding laboratory follow-up data. Age = 18 years at the time of data collection.
Exclusion criteria
Exclusion criteria: Missing or incomplete clinical follow-up data. Missing or non-evaluable liver stiffness measurements. Presence of other chronic liver diseases apart from primary biliary cholangitis that could significantly affect data interpretation. Liver transplantation prior to initiation of elafibranor therapy.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in liver stiffness (LSM, kPa) over time during elafibranor therapy. | — |
Secondary
| Measure | Time frame |
|---|---|
| • Changes in biochemical parameters (AP, bilirubin, GPT, GOT, ?-GT, albumin, INR) over time. • Correlation between LSM and biochemical markers. • Occurrence of liver-related complications (ascites, variceal bleeding, hepatic encephalopathy, HCC). • Correlation between response to therapy and survival. | — |
Countries
Germany
Contacts
Public ContactJassin Rashidi
Universitätsmedizin Essen
Outcome results
None listed