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

Sponsor

University of Aarhus (Other)

Overall Status

Completed

CT.gov ID

NCT02528461

Collaborator

Aarhus University Hospital (Other)

Enrollment

Location

Actual Duration (Months)

1.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Hepatitis C	Drug: Galactose Procedure: Gastroscopy Procedure: Liver biopsy Procedure: Fibroscan Procedure: Liver vein catheterization Drug: Sofosbuvir

Study Design

Study Type:

Observational

Actual Enrollment :

71 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official 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

Actual Study Start Date :

Jan 1, 2015

Actual Primary Completion Date :

Jan 1, 2019

Actual Study Completion Date :

Jan 1, 2020

Arms and Interventions

Arm	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: 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 Drug: Sofosbuvir

Arm

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: 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

Drug: Sofosbuvir

Outcome Measures

Primary Outcome Measures

Changes in the macrophage activation markers sCD163 and sCD206 [1 year]

Secondary Outcome Measures

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.