Chronic Hepatitis CNCT02545387
Hepatitis C Virus in Neutrophil Granulocyte Progenitor Cells
An observational study of Chronic Hepatitis C, run by Medical University of Graz at 1 site in Austria.
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. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Chronic Hepatitis C
- How many people
- 0 participants
- Where
- 1 siteAustria
- Study dates
- Jan 2015to Dec 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: cells and tissue from patients with chronic hepatitis C virus infection
Who may be able to join
- chronic hepatitis C
- Genotype 1-4
Who cannot join
- acute hepatitis C
Trial locations and contacts
1 site in 1 country.
Austria1 site
Department of Internal Medicine, Medical University of Graz
Graz, 8010
About this study
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.
Read the 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.
- Conditions
- Chronic Hepatitis C
- Medical subject headings
- Hepatitis C, Chronic
What is being measured
The primary outcome is the main question the study is designed to answer.
viral RNA
hepatitis C virus RNA
Measured: day 1
Secondary outcomes (2)
neutrophil phagocytic capacity
function of neutrophil granulocytes in hepatitis C patients
Measured: day 1
hepatitis C virus proteins
presence of hepatitis C virus proteins in neutrophils
Measured: day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2015 (estimated)
- Study startJan 2015
- Primary completionDec 2018
- Study completionDec 2018
Why it stopped: Logistical problems
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Hepatitis CStudies of the same condition, open and under way.
- More trials run by Medical University of GrazThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Graz
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Vanessa Stadlbauer, Principal investigator, Medical University of Graz
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02545387
- Sponsor's protocol ID
- HCV-KM
- Status last verified
- Dec 2018
- First submitted
- 29 Jul 2015
- Last updated
- 19 Dec 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hepatitis C Virus in Neutrophil Granulocyte Progenitor Cells
- ClinicalTrials.gov ID
- NCT02545387
- Acronym / sponsor ID
- HCV-KM
- Conditions
- Chronic Hepatitis C
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Logistical problems
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Medical University of GrazUniversity, hospital or other
- Study start
- Jan 2015 (actual)
- Primary completion
- Dec 2018 (actual)
- Study completion
- Dec 2018 (actual)
- First posted
- 10 Sep 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- cells and tissue from patients with chronic hepatitis C virus infection
Key inclusion criteria (2 listed)
- chronic hepatitis C
- Genotype 1-4
Key exclusion criteria (1 listed)
- acute hepatitis C
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
viral RNA
Time frame: day 1
hepatitis C virus RNA
2 secondary outcomes
neutrophil phagocytic capacity
Time frame: day 1
hepatitis C virus proteins
Time frame: day 1
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Vanessa Stadlbauer principal investigator
Medical University of Graz
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Hepatitis C, run by Medical University of Graz at 1 site in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 19 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
viral RNA (time frame: day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Dec 2018.