Expression of Inflammasomes in HCV Patients
Inflammasome
1 other identifier
interventional
50
0 countries
N/A
Brief Summary
Hepatitis C virus has been identified a quarter of a decade ago as a leading cause of chronic viral hepatitis that can lead to cirrhosis and hepatocellular carcinoma. Only a minority of patients can clear the virus spontaneously during acute infection. Elimination of HCV during acute infection correlates with a rapid induction of innate and a delayed induction of adaptive immune responses. The majority of patients is unable to clear the virus and develops viral persistence despite the ongoing innate and adaptive immune response. The virus usually develops several strategies to escape these immune responses.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4
Started Jan 2020
Shorter than P25 for phase_4
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
January 1, 2020
CompletedFirst Submitted
Initial submission to the registry
January 22, 2020
CompletedFirst Posted
Study publicly available on registry
January 28, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2020
CompletedJanuary 28, 2020
January 1, 2020
5 months
January 22, 2020
January 24, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
changes in the exprssion level of inflammasomes
observe the changes in the exprssion level of inflammasomes in the selected chronic HCV patients before treatment with Sofosbuvir 400 mg and Daclatasvir 60 mg daily for 12 weeks and after sustained virological response at 12 weeks following the end of treatment (SVR12).
6 monthes
Study Arms (2)
chronic hepatitis C virus patients
EXPERIMENTAL50 chronic hepatitis C virus patients taking will be trated with direct acting antiviral treatment with three months regimen (Sofosbuvir + Daclatasvir).
treated chronic hepatitis C virus patients
EXPERIMENTALthe selected 50 chronic hepatitis C virus patients received direct acting antivirals: Sofosbuvir 400 mg and Daclatasvir 60 mg daily for 12 weeks and were assessed for sustained virological response at 12 weeks following the end of treatment (SVR12).
Interventions
pro-inflammatory cytokines measured in the serum
Eligibility Criteria
You may qualify if:
- Chronic hepatitis C virus patients.
- Patients do not start treatment protocol.
You may not qualify if:
- Pregnant women.
- Hepato-cellular carcinoma patients.
- Autoimmune disease patients.
- Patients with liver cirrhosis.
- Patients who refuse to participate in the study
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (5)
Chen H, He G, Chen Y, Zhang X, Wu S. Differential Activation of NLRP3, AIM2, and IFI16 Inflammasomes in Humans with Acute and Chronic Hepatitis B. Viral Immunol. 2018 Nov;31(9):639-645. doi: 10.1089/vim.2018.0058. Epub 2018 Sep 15.
PMID: 30222506BACKGROUNDKanneganti TD. Central roles of NLRs and inflammasomes in viral infection. Nat Rev Immunol. 2010 Oct;10(10):688-98. doi: 10.1038/nri2851. Epub 2010 Sep 17.
PMID: 20847744BACKGROUNDYingLi H, Shumei L, Qian Y, Tianyan C, Yingren Z, Wei C. Proapoptotic IL-18 in patients with chronic hepatitis C treated with pegylated interferon-alpha. Clin Exp Med. 2009 Jun;9(2):173-8. doi: 10.1007/s10238-009-0041-5. Epub 2009 Feb 24.
PMID: 19238512BACKGROUNDBurchill MA, Roby JA, Crochet N, Wind-Rotolo M, Stone AE, Edwards MG, Dran RJ, Kriss MS, Gale M Jr, Rosen HR. Rapid reversal of innate immune dysregulation in blood of patients and livers of humanized mice with HCV following DAA therapy. PLoS One. 2017 Oct 17;12(10):e0186213. doi: 10.1371/journal.pone.0186213. eCollection 2017.
PMID: 29040318BACKGROUNDShi J, Li Y, Chang W, Zhang X, Wang FS. Current progress in host innate and adaptive immunity against hepatitis C virus infection. Hepatol Int. 2017 Jul;11(4):374-383. doi: 10.1007/s12072-017-9805-2. Epub 2017 Jun 22.
PMID: 28643186BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Asmaa Salah El-dien Gaber, lecturer
participator in the research
- PRINCIPAL INVESTIGATOR
Mohamed Ahmed Medhat, lecturer
participator in the research
- PRINCIPAL INVESTIGATOR
Sara Fergany Abd El-hamid, student
participator in the research
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- FACTORIAL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- princible inverstigator
Study Record Dates
First Submitted
January 22, 2020
First Posted
January 28, 2020
Study Start
January 1, 2020
Primary Completion
June 1, 2020
Study Completion
July 1, 2020
Last Updated
January 28, 2020
Record last verified: 2020-01