Screening of patients with Crigler-Najjar

Screening of patients with Crigler-Najjar - Screening of patients with Crigler-Najjar

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON41149

Enrollment

Registered

2014-12-24

Start date

2015-01-28

Completion date

Unknown

Last updated

2024-04-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

hereditary unconjugated hyperbilirubinemia/ hereditary jaundice

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Patients with the inherited liver disorder Crigler-Najjar With a known mutation Able to understand and give fully informed written consent Age between 18-75 year

Exclusion criteria

Exclusion criteria: Crigler-Najjar patients who underwent a livertransplantation Patients with jaundice/icterus caused by a different pathology other than Crigler-Najjar disease Patients which are not able to understand and give fully informed written consent

Design outcomes

Primary

Measure	Time frame
Serum: - AAV8 antibodies - Serum bilirubin (conjugated and unconjugated) - Liver trasnaminases (AST and ALT) - Serology Hepatitis A, B and C Quality of life (questionnaire SF-36) Extent of phototherapy (duration/intensity) Ultrasound: liver, spleen and vena portae Fibroscan: liver	—

Secondary

Measure	Time frame
non applicable	—

Countries

Netherlands

Outcome results