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

November 3, 2020 updated by: University of Aarhus

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

16

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Aarhus, Denmark, 8000
        • Department of Hepatology and Gastroenterology, Aarhus University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Chronic hepatitis C patients initiating direct-acting anti-viral therapy.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
AbbVie
Procedure: Liver vein catheterization
Procedure: Functional Hepatic Nitrogen Clearance (FHNC)
Procedure: Galactose Elimination Capacity (GEC)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in the hepatic venous pressure gradient determined by liver vein catheterization from baseline to 12 weeks
Time Frame: 12 weeks
12 weeks
Change in the hepatic venous pressure gradient determined by liver vein catheterization from baseline to 1 year
Time Frame: 1 year
1 year

Secondary Outcome Measures

Outcome Measure
Time Frame
Changes in the levels of the macrophage specific activation marker sCD163
Time Frame: Before, during and after treatment - 60 weeks
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
After 12 weeks treatment
Changes in the functional hepatic nitrogen clearance (FHNC)
Time Frame: After 12 weeks treatment
After 12 weeks treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Aarhus

Collaborators

AbbVie
Aarhus University Hospital

Investigators

  • Principal Investigator: Henning Grønbæk, Professor, Aarhus University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2015

Primary Completion (Actual)

March 1, 2019

Study Completion (Actual)

November 1, 2020

Study Registration Dates

First Submitted

August 13, 2015

First Submitted That Met QC Criteria

August 14, 2015

First Posted (Estimate)

August 18, 2015

Study Record Updates

Last Update Posted (Actual)

November 4, 2020

Last Update Submitted That Met QC Criteria

November 3, 2020

Last Verified

November 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HCV sCD163 AbbVie

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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