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

New AbbVie Direct Acting Antiviral (DAA) Treatment of Chronic Hepatitis C Infection - Effects on the Macrophage Activation Marker Soluble CD163, Portal Hypertension, and Metabolic Liver Function

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02526641

Enrollment

Registered

2015-08-18

Start date

2015-08-31

Completion date

2020-11-30

Last updated

2020-11-04

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

Conditions

Hepatitis C

Keywords

Direct acting antiviral treatment, sCD163, Portal hypertension, Metabolic liver function, Cirrhosis

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).

Interventions

PROCEDUREFunctional Hepatic Nitrogen Clearance (FHNC)

PROCEDUREGalactose Elimination Capacity (GEC)

PROCEDURELiver vein catheterization

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

30 Years to 70 Years

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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026