Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Hepatitis C Virus in Neutrophil Granulocyte Progenitor Cells

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02545387
Recruitment Status : Withdrawn (Logistical problems)
First Posted : September 10, 2015
Last Update Posted : December 18, 2018
Sponsor:
Information provided by (Responsible Party):
Medical University of Graz

Brief 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.

Condition or disease
Chronic Hepatitis C

Detailed 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.


Layout table for study information
Study Type : Observational
Actual Enrollment : 0 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Hepatitis C Virus in Neutrophil Granulocyte Progenitor Cells
Actual Study Start Date : January 2015
Actual Primary Completion Date : December 2018
Actual Study Completion Date : December 2018

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. viral RNA [ Time Frame: day 1 ]
    hepatitis C virus RNA


Secondary Outcome Measures :
  1. neutrophil phagocytic capacity [ Time Frame: day 1 ]
    function of neutrophil granulocytes in hepatitis C patients

  2. hepatitis C virus proteins [ Time Frame: day 1 ]
    presence of hepatitis C virus proteins in neutrophils


Biospecimen Retention:   Samples Without DNA
serum liver tissue bone marrow


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
cells and tissue from patients with chronic hepatitis C virus infection
Criteria

Inclusion Criteria:

  • chronic hepatitis C
  • Genotype 1-4

Exclusion Criteria:

  • acute hepatitis C

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02545387


Locations
Layout table for location information
Austria
Department of Internal Medicine, Medical University of Graz
Graz, Austria, 8010
Sponsors and Collaborators
Medical University of Graz
Investigators
Layout table for investigator information
Principal Investigator: Vanessa Stadlbauer Medical University of Graz

Layout table for additonal information
Responsible Party: Medical University of Graz
ClinicalTrials.gov Identifier: NCT02545387     History of Changes
Other Study ID Numbers: HCV-KM
First Posted: September 10, 2015    Key Record Dates
Last Update Posted: December 18, 2018
Last Verified: December 2018

Additional relevant MeSH terms:
Layout table for MeSH terms
Hepatitis
Hepatitis A
Hepatitis C
Hepatitis, Chronic
Hepatitis C, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections