Macrophages, Portal Hypertension, and Liver Function During AbbVie Treatment of Chronic Hepatitis C

University of Aarhus

Status: Completed

Conditions: Hepatitis C

Treatments: Procedure: Galactose Elimination Capacity (GEC); Procedure: Liver vein catheterization; Procedure: Functional Hepatic Nitrogen Clearance (FHNC)

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT02526641

HCV sCD163 AbbVie

Details and patient eligibility

About

Investigation of the effects of the new Abbvie direct acting anti-viral (DAA) treatment of chronic viral hepatitis C infection on the macrophage specific activation marker soluble CD163, portal hypertension determined by the hepatic venous pressure gradient (HVPG), and metabolic liver function determined by the galactose elimination capacity (GEC) test and the functional hepatic nitrogen clearance (FHNC).

Enrollment: 16 patients

Sex: All

Ages: 30 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Chronic hepatitis C genotype 1 or 4 patients initiating the new AbbVie treatment (paritaprevir, ritonavir, ombitasvir og dasabuvir sammen med ribavirin)
• Child-Pugh A liver cirrhosis

Exclusion criteria

• Severe liver dysfunction - Child-Pugh klasse B-C
• Life expectancy less than 6 months
• planned liver transplantation or TIPS procedure within 6 months
• non-compliance to treatment or study procedures
• allergy to the DAA drugs used (paritaprevir, ritonavir, ombitasvir, dasabuvir, and ribavirin)
• pregnancy or expected pregnancy during the study (anti-conception has to be used)
• breast feeding
• portal vein thrombosis
• liver cancer or other malignancies
• alcohol consumption

Trial design

16 participants in 1 patient group

AbbVie

Treatment:

Procedure: Liver vein catheterization

Procedure: Galactose Elimination Capacity (GEC)

Procedure: Functional Hepatic Nitrogen Clearance (FHNC)