Neutrophil Function During Therapy With Protease Inhibitors in Chronic Hepatitis C
Neutrophil Function During Combination Therapy With Protease Inhibitors in Chronic Hepatitis C
1 other identifier
observational
174
1 country
1
Brief Summary
The aim of this study is to characterize neutrophil function in patients undergoing chronic hepatitis C triple therapy with protease inhibitors in comparison to dual therapy with peginterferon and ribavirin and with interferon free treatment regimen to thereby elucidate the possible mechanisms of protease-inhibitor associated infections.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Nov 2014
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2014
CompletedFirst Submitted
Initial submission to the registry
July 29, 2015
CompletedFirst Posted
Study publicly available on registry
September 9, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2020
CompletedJanuary 12, 2023
January 1, 2023
6.2 years
July 29, 2015
January 11, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
neutrophil phagocytosis
phagocytosis of labelled E.coli
12 weeks
Secondary Outcomes (1)
number of infections
12 weeks
Eligibility Criteria
patients with chronic hepatitis C undergoing antiviral therapy
You may qualify if:
- chronic hepatitis C
- planned antiviral therapy
You may not qualify if:
- immunosuppressive medication
- active infection at baseline
- treatment with antibiotics within the last two weeks
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Department of Internal Medicine, Medical University of Graz
Graz, 8010, Austria
Related Publications (2)
Spindelboeck W, Horvath A, Tawdrous M, Schmerbock B, Zettel G, Posch A, Streit A, Jurse P, Lemesch S, Horn M, Wuensch G, Stiegler P, Stauber RE, Leber B, Stadlbauer V. Triple Therapy with First Generation Protease Inhibitors for Hepatitis C Markedly Impairs Function of Neutrophil Granulocytes. PLoS One. 2016 Mar 3;11(3):e0150299. doi: 10.1371/journal.pone.0150299. eCollection 2016.
PMID: 26938078RESULTLeber B, Balazs I, Horvath A, Posch A, Streit A, Spindelbock W, Feldbacher N, Stiegler P, Stauber RE, Rechberger GN, Kollroser M, Sattler W, Nusshold C, Stadlbauer V. Direct acting antiviral therapy rescues neutrophil dysfunction and reduces hemolysis in hepatitis C infection. Transl Res. 2021 Jun;232:103-114. doi: 10.1016/j.trsl.2020.12.005. Epub 2020 Dec 19.
PMID: 33352296RESULT
Biospecimen
Serum Plasma
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Vanessa Statdlbauer, MD
Medical University of Graz
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 29, 2015
First Posted
September 9, 2015
Study Start
November 1, 2014
Primary Completion
December 31, 2020
Study Completion
December 31, 2020
Last Updated
January 12, 2023
Record last verified: 2023-01