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Completed

NCT Number: NCT02528461

Macrophage Activation Markers During Sofosbuvir-based Treatment Regimes of Chronic Hepatitis C

The purpose of the study is to investigate how the liver is affected with regard to inflammation and fibrosis during Sofosbuvir based treatment regimes of chronic hepatitis C.

In order to examine how the liver heals, we want to use blood samples to check for the occurrence of special liver inflammation cells (CD163 and CD206). To assess to which extent fibrosis disappear during treatment, we want to examine the liver with FibroScan (a type of ultrasound examination) and also preferably with extraction of a small tissue sample. We want to examine how the liver function as inflammation and scar tissue decrease, especially concerning the liver's ability to produce proteins. Furthermore, we want to examine with a gastroscopy, if the circulation of blood in the liver is improved after successful treatment with the expected result that potential varicose veins in the esophagus vanish.

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Key information

Conditions

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

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Aarhus University Hospital

Aarhus C, 8000, Denmark

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Hepatitis C and initiation of sofosbuvir-based direct-acting antiviral treatment

Exclusion criteria

  • HIV or Hepatitis B Virus

Treatment and study plan

galactose

Drug

A test to investigate the liver's ability to metabolize galactose to glucose by injecting galactose followed by measurements of blood glucose and the quantification of galactose in the urine.

Other names: GEC

gastroscopy

Procedure

Liver biopsy

Procedure

Fibroscan

Procedure

Liver vein catheterization

Procedure

Sofosbuvir

Drug

Primary outcomes

  1. Changes in the macrophage activation markers sCD163 and sCD206

    Time frame: 1 year

Secondary outcomes

  1. Changes in liver fibrosis with fibroscan

    Time frame: 1 year

    Liver fibrosis will be determined using fibroscan, and reported as changes in the amount of fibrosis in the liver

  2. Changes in histological liver fibrosis

    Time frame: 1 year

    Liver fibrosis will be also be determined on liver biopsies. Determining changes in fibrosis from baseline to after treatment.

  3. Changes in clinical status

    Time frame: 1 year

    Defined by the number of patients with the occurrence of cirrhosis complications, eg. ascites, hepatic encephalopathy, variceal bleeding.

  4. Changes in hepatic venous pressure

    Time frame: 1 year

    Hepatic venous pressure will be assessed with liver vein catheterization before and after treatment and the results reported as changes between baseline and after treatment.

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

    Time frame: 1 year

    GEC will be applied before and after treatment.

Sponsors and collaborators

Lead sponsor

University of Aarhus

Other

Collaborators

  • Aarhus University Hospital

Registry information

Official study title

Measuring Inflammation Cells (CD163 and CD206) With the Purpose of Examining Reduction of Fibrosis in the Liver of Chronic Hepatitis C Patients Following Treatment With the Medication Sofosbuvir

Important dates

Study start
2015
Primary completion
2019
Study completion
2020
First posted
Aug 19, 2015
Registry last updated
Apr 7, 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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