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Completed

NCT Number: NCT02526641

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

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).

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Key information

Conditions

Hepatitis C Blood-Borne Infections Communicable Diseases Digestive System Diseases Fibrosis Flaviviridae Infections Hepatitis Hepatitis, Viral, Human Hypertension, Portal Infections Liver Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms RNA Virus Infections Virus Diseases

Age range

30 year–70 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of Hepatology and Gastroenterology, Aarhus University Hospital

Aarhus, 8000, Denmark

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Functional Hepatic Nitrogen Clearance (FHNC)

Procedure

Galactose Elimination Capacity (GEC)

Procedure

Liver vein catheterization

Procedure

Primary outcomes

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

    Time frame: 12 weeks

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

    Time frame: 1 year

Secondary outcomes

  1. Changes in the levels of the macrophage specific activation marker sCD163

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

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

    Time frame: After 12 weeks treatment

  3. Changes in the functional hepatic nitrogen clearance (FHNC)

    Time frame: After 12 weeks treatment

Sponsors and collaborators

Lead sponsor

University of Aarhus

Other

Collaborators

  • Aarhus University Hospital
  • AbbVie

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2019
Study completion
2020
First posted
Aug 18, 2015
Registry last updated
Nov 4, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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