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

April 6, 2020 updated by: University of Aarhus

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

71

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 C, Denmark, 8000
        • 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

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients with chronic hepatitis C initiating sofosbuvir-based direct-acting antiviral treatment.

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • HIV or Hepatitis B Virus

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

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Sofosbuvir

All patients receiving Sofosbuvir based treatment regimes during the study period will be included in the study.

All patients will receive all interventions (galactose elimination capacity test, gastroscopy, fibroscan), except liver biopsy which the patients may decline to participate in without affecting the participation in the rest of the study. If varices are found during the gastroscopy a liver vein catheterization will be performed.
Drug: Sofosbuvir
Drug: Galactose
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
Procedure: Gastroscopy
Procedure: Liver biopsy
Procedure: Fibroscan
Procedure: Liver vein catheterization

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Changes in the macrophage activation markers sCD163 and sCD206
Time Frame: 1 year
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
1 year
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.
1 year
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.
1 year
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.
1 year
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.
1 year

Collaborators and Investigators

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

Sponsor

University of Aarhus

Collaborators

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)

January 1, 2015

Primary Completion (Actual)

January 1, 2019

Study Completion (Actual)

January 1, 2020

Study Registration Dates

First Submitted

August 14, 2015

First Submitted That Met QC Criteria

August 18, 2015

First Posted (Estimate)

August 19, 2015

Study Record Updates

Last Update Posted (Actual)

April 7, 2020

Last Update Submitted That Met QC Criteria

April 6, 2020

Last Verified

September 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HCV sCD163 Sofosbuvir

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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