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

Completed

• Conditions: Hepatitis C
• Interventions: Procedure: Functional Hepatic Nitrogen Clearance (FHNC); Procedure: Galactose Elimination Capacity (GEC); Procedure: Liver vein catheterization

• Registration Number: NCT02526641
• Lead Sponsor: University of Aarhus

Brief Summary

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2015-08
• Study First Submitted: 2015-08-13
• Study First Submitted QC: 2015-08-14
• Study First Posted: 2015-08-18
• Primary Completion: 2019-03
• Status Verified: 2020-11
• Study Completion: 2020-11
• Last Update Submitted: 2020-11-03
• Last Update Posted: 2020-11-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 16

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

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
AbbVie	Functional Hepatic Nitrogen Clearance (FHNC)	-
AbbVie	Liver vein catheterization	-
AbbVie	Galactose Elimination Capacity (GEC)	-

Primary Outcome Measures

Name	Time	Method
Change in the hepatic venous pressure gradient determined by liver vein catheterization from baseline to 12 weeks	12 weeks
Change in the hepatic venous pressure gradient determined by liver vein catheterization from baseline to 1 year	1 year

Secondary Outcome Measures

Name	Time	Method
Changes in the levels of the macrophage specific activation marker sCD163	Before, during and after treatment - 60 weeks
Changes in metabolic liver function determined by the galactose elimination capacity (GEC) test	After 12 weeks treatment
Changes in the functional hepatic nitrogen clearance (FHNC)	After 12 weeks treatment

Trial Locations

Locations (1)

Department of Hepatology and Gastroenterology, Aarhus University Hospital; 🇩🇰 Aarhus, Denmark