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

Completed

• Conditions: Hepatitis C
• Interventions: Drug: Galactose; Procedure: Gastroscopy; Procedure: Liver biopsy; Procedure: Fibroscan; Procedure: Liver vein catheterization; Drug: Sofosbuvir

• Registration Number: NCT02528461
• Lead Sponsor: University of Aarhus

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-01
• Study First Submitted: 2015-08-14
• Study First Submitted QC: 2015-08-18
• Study First Posted: 2015-08-19
• Primary Completion: 2019-01
• Status Verified: 2019-09
• Study Completion: 2020-01
• Last Update Submitted: 2020-04-06
• Last Update Posted: 2020-04-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 71

Inclusion Criteria

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

Exclusion Criteria

• HIV or Hepatitis B Virus

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Sofosbuvir	Fibroscan	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.
Sofosbuvir	Gastroscopy	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.
Sofosbuvir	Liver vein catheterization	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.
Sofosbuvir	Liver biopsy	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.
Sofosbuvir	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.
Sofosbuvir	Galactose	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.

Primary Outcome Measures

Name	Time	Method
Changes in the macrophage activation markers sCD163 and sCD206	1 year

Secondary Outcome Measures

Name	Time	Method
Changes in liver fibrosis with fibroscan	1 year	Liver fibrosis will be determined using fibroscan, and reported as changes in the amount of fibrosis in the liver
Changes in histological liver fibrosis	1 year	Liver fibrosis will be also be determined on liver biopsies. Determining changes in fibrosis from baseline to after treatment.
Changes in clinical status	1 year	Defined by the number of patients with the occurrence of cirrhosis complications, eg. ascites, hepatic encephalopathy, variceal bleeding.
Changes in hepatic venous pressure	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.
Changes in metabolic liver function determined by the galactose elimination capacity (GEC) test	1 year	GEC will be applied before and after treatment.

Trial Locations

Locations (1)

Aarhus University Hospital; 🇩🇰 Aarhus C, Denmark