Pruritus in chronic cholestatic liver diseases in children and adolescents: The need for a more nuanced classification.

• Conditions: K83.0; Cholangitis; K76.8; autoimmune sclerosing cholangitisprogressive familial intrahepatic cholestasis; Other specified diseases of liver

• Registration Number: DRKS00026913
• Lead Sponsor: Medizinische Universität Graz

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Completion: 2020-08-01
• Study Start: 2021-10-18
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 52

Inclusion Criteria

Male or female subjects between the ages of 0 and 19 years
-Diagnosis of CCLD (ASC, PFIC, chronic cholestasis of unknown origin with/without pruritus)
-Available information concerning date of birth, sex, date of blood collection

Exclusion Criteria

-Interruption of enterohepatic circulation
-Chronic diarrhea requiring specific intravenous fluid/ nutritional intervention
-Liver transplant
-Decompensated cirrhosis (INR = 1.5 (not due to vitamin K deficiency), albumin < 3.0 mg/dl, ascites, hepatic encephalopathy)
-Known diagnosis of immunodeficiency
-Any pregnant or lactating female
-Diabetes mellitus
-Chemotherapy

Study & Design

• Study Type: observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Determination of total bile acid-/muricholic acid levels and profiles and autotaxin antigen levels in serum of pediatric patients with chronic cholestatic liver diseases.

Secondary Outcome Measures

Name	Time	Method
1. Determination of pruritus via PVAS (Pruritus Visual Analogue Scale).<br><br>2. Determination of total bile acid-/muricholic acid levels and profiles by highperformance-liquidchromatography/tandem-massspectrometry.<br><br>3. Determination of autotaxin-antigen levels via ELISA Immunoassay.