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COMPLETED

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

NCT02526641•University of Aarhus

View on ClinicalTrials.gov

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).

Eligibility

Age

30 - 70 years

Sex

ALL

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

Locations (1)

Department of Hepatology and Gastroenterology, Aarhus University Hospital

Aarhus, Denmark

Key Dates

Start Date

August 1, 2015

Primary Completion Date

March 1, 2019

Completion Date

November 1, 2020

Last Updated

November 4, 2020

Enrollment

ACTUAL participants

Conditions

Hepatitis C

Interventions

Functional Hepatic Nitrogen Clearance (FHNC)

PROCEDURE

Galactose Elimination Capacity (GEC)

PROCEDURE

Liver vein catheterization

PROCEDURE

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RECRUITINGNA

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: November 4, 2020Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

Implementing Low-Barrier HCV Treatment in a Jail Setting

Project I Test: Implementing HIV Testing in Opioid Treatment Programs

Persuasive Health Communication Intervention for HIV/HCV

The National Australian HCV Point-of-Care Testing Program

Digitalized Surveillance Management for Liver Cancer Risk Population in Improving Eearly Diagnosis Efficancy in Chinese Population (dSEARCH)

Acceptability of Simultaneous Screening for Viral Hepatitis B, C and HIV Among Drug Users in Non-conventional Structures