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

University of Aarhus16 enrolled

Overview

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).

Study Type

OBSERVATIONAL

Enrollment

Conditions

Hepatitis C

Interventions

Functional Hepatic Nitrogen Clearance (FHNC)PROCEDURE

Galactose Elimination Capacity (GEC)PROCEDURE

Liver vein catheterizationPROCEDURE

Eligibility

Sex: ALLMin age: 30 YearsMax age: 70 Years

Medical Language ↔ Plain English

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

Locations (1)

Department of Hepatology and Gastroenterology, Aarhus University Hospital

Aarhus, Denmark

Outcomes

Primary Outcomes

Change in the hepatic venous pressure gradient determined by liver vein catheterization from baseline to 12 weeks

Time frame: 12 weeks

Change in the hepatic venous pressure gradient determined by liver vein catheterization from baseline to 1 year

Time frame: 1 year

Secondary Outcomes

Changes in the levels of the macrophage specific activation marker sCD163

Time frame: Before, during and after treatment - 60 weeks

Changes in metabolic liver function determined by the galactose elimination capacity (GEC) test

Time frame: After 12 weeks treatment

Changes in the functional hepatic nitrogen clearance (FHNC)

Time frame: After 12 weeks treatment

Data from ClinicalTrials.gov

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