Hepatitis C
Conditions
Keywords
Sofosbuvir, Direct acting anti-viral treatment, liver cirrhosis
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.
Interventions
DRUGGalactose
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.
PROCEDUREGastroscopy
PROCEDURELiver biopsy
PROCEDUREFibroscan
PROCEDURELiver vein catheterization
DRUGSofosbuvir
Sponsors
Aarhus University Hospital
University of Aarhus
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Hepatitis C and initiation of sofosbuvir-based direct-acting antiviral treatment
Exclusion criteria
* HIV or Hepatitis B Virus
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Changes in the macrophage activation markers sCD163 and sCD206 | 1 year |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changes in metabolic liver function determined by the galactose elimination capacity (GEC) test | 1 year | GEC will be applied before and after treatment. |
| 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. |
Countries
Denmark
Outcome results
None listed