Trial Details

Not Recruiting
Basic Information
Clinical ID c2025
Identifier DRKS00033902
Trial Title Screening of patients with atypical primary biliary cholangitis (PBC) or primary sclerosing cholangitis (PSC) for genetic defects in hepatocanalicular transporters - TAPP Trial
Trial URL Visit Original Page
Study Information
Study Results

No results available

Conditions K76.8;Other specified diseases of liver;K76.8
Interventions Group 1: Patients with atypical PBC (defined as AMA-negative PBC without histological confirmation), or atypical PSC (defined as large- or small-duct PSC without concomitant inflammatory bowel disease (IBD)); whole exome sequencing (WES) with digital panel analysis of 46 cholestasis-associated genes is performed in these patients to identify individuals with a hereditary cholestatic liver disease in this cohort. For this purpose, an additional blood sample is taken once. Furthermore, the clinical and laboratory characteristics of the disease are extracted from the patient record. For comparison, genetic data and patient characteristics are also determined and recorded for patients with confirmed PBC or PSC (Arm 2) and for healthy control subjects (Arm 3). Group 2: Patients with confirmed diagnosis of PBC or PSC (disease controls) Group 3: Patients with hepatitis C virus infection in sustained virological response after antiviral therapy, with normal liver values and no indication of structural liver damage (healthy controls)
Participant Information
Sponsor Leipzig University Medical Center, Department of Medicine II, Division of Hepatology
City -
Country/Region Germany
Enrollment Criteria
Sex Requirement ALL
Age Requirement -
Study Design
Study Type observational
Phase Not Available
Time Information
Start Date 2025-04-24
Primary Completion Date -
Completion Date -