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NCT02545387 Clinical Trial

Hepatitis C Virus in Neutrophil Granulocyte Progenitor Cells

Chronic Hepatitis C Clinical Trial

Official title:
Hepatitis C Virus in Neutrophil Granulocyte Progenitor Cells

Clinical Trial Details — Status: Withdrawn

Administrative data
NCT number NCT02545387
Other study ID # HCV-KM
Secondary ID
Status Withdrawn
Phase
First received
Last updated
Start date January 2015
Est. completion date December 2018

Study information
Verified date December 2018
Source Medical University of Graz
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Patients with hepatitis C show impaired neutrophil function. It is not known whether this is a direct of an indirect phenomenon. Using bone marrow biopsies from patients with hepatitis C it is possible to see whether neutrophil granulocyte progenitors are already infected with hepatitis C.

Description:

Neutrophil granulocytes are important components of the innate immune system and pioneers in the fight against both fungal and bacterial infections. If pathogens enter the body, they are marked as foreign by antibodies and the complement system. Afterwards receptors on the neutrophils recognize and bind on these foreign substances to make them harmless. This process is called phagocytosis. Hepatitis C virus (HCV) and neutrophils are rarely associated. The HCV belongs to the Flaviviridae. It is a single-stranded, enveloped RNA virus with a positive polarity, which cause chronic hepatitis C (CHC) in approximately 170 million people worldwide. Subsequently, such an infection leads to liver cirrhosis and carcinoma in a significant proportion of patients. The virus infects mainly hepatocytes, but extrahepatic replication has also been shown. HCV usually enters the cell through receptor-mediated endocytosis (claudin-1, cluster of differentiation (CD)81, occludin and scavenger receptor 1), before it abuses the cell's own infrastructure for the viral protein synthesis.

The aim of this study is to determine neutrophil function in chronic hepatitis C infected patients. Furthermore the investigators want to examine if neutrophils or their precursor cells are infected with HCV and if this leads to their dysfunction.

Recruitment information / eligibility
Status Withdrawn
Enrollment 0
Est. completion date December 2018
Est. primary completion date December 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years to 99 Years
Eligibility Inclusion Criteria:

- chronic hepatitis C

- Genotype 1-4

Exclusion Criteria:

- acute hepatitis C

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
Austria Department of Internal Medicine, Medical University of Graz Graz

Sponsors (1)
Lead Sponsor Collaborator
Medical University of Graz

Country where clinical trial is conducted

Austria, 

Outcome
Type Measure Description Time frame Safety issue
Primary viral RNA hepatitis C virus RNA day 1
Secondary neutrophil phagocytic capacity function of neutrophil granulocytes in hepatitis C patients day 1
Secondary hepatitis C virus proteins presence of hepatitis C virus proteins in neutrophils day 1
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