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

Hepatitis C Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02528461
• Other study ID #: HCV sCD163 Sofosbuvir
• Status: Completed
• Start date: January 2015
• Est. completion date: January 2020

Study information

• Verified date: September 2019
• Source: University of Aarhus
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 71
• Est. completion date: January 2020
• Est. primary completion date: January 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• HIV or Hepatitis B Virus

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis A
• Hepatitis C
• Hepatitis C, Chronic

Intervention

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.

Procedure:
• Gastroscopy

• Liver biopsy

• Fibroscan

• Liver vein catheterization

Drug:
• Sofosbuvir

Locations

Country	Name	City	State
Denmark	Aarhus University Hospital	Aarhus C

Sponsors (2)

Lead Sponsor	Collaborator
University of Aarhus	Aarhus University Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in the macrophage activation markers sCD163 and sCD206		1 year
Secondary	Changes in liver fibrosis with fibroscan	Liver fibrosis will be determined using fibroscan, and reported as changes in the amount of fibrosis in the liver	1 year
Secondary	Changes in histological liver fibrosis	Liver fibrosis will be also be determined on liver biopsies. Determining changes in fibrosis from baseline to after treatment.	1 year
Secondary	Changes in clinical status	Defined by the number of patients with the occurrence of cirrhosis complications, eg. ascites, hepatic encephalopathy, variceal bleeding.	1 year
Secondary	Changes in hepatic venous pressure	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
Secondary	Changes in metabolic liver function determined by the galactose elimination capacity (GEC) test	GEC will be applied before and after treatment.	1 year