Clinical trial NCT04244383: Expression of Inflammasomes in HCV Patients
Official title: Expression of Inflammasomes in HCV Patients Before and After Treatment
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Hepatitis C
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2020-01-28
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Intervention model description: chronic hepatitis C virus patients
Primary purpose: OTHER

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.


Eligibility criteria: Inclusion Criteria:

* Chronic hepatitis C virus patients.
* Patients do not start treatment protocol.

Exclusion Criteria:

* Pregnant women.
* Hepato-cellular carcinoma patients.
* Autoimmune disease patients.
* Patients with liver cirrhosis.
* Patients who refuse to participate in the study

Primary outcomes:
measure: changes in the exprssion level of inflammasomes
timeFrame: 6 monthes
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: participator in the research
name: Asmaa Salah El-dien Gaber, lecturer
role: PRINCIPAL_INVESTIGATOR
affiliation: participator in the research
name: Mohamed Ahmed Medhat, lecturer
role: PRINCIPAL_INVESTIGATOR
affiliation: participator in the research
name: Sara Fergany Abd El-hamid, student
role: PRINCIPAL_INVESTIGATOR
References:
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citation: Kanneganti 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.
citation: YingLi 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.
citation: Burchill 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.
citation: Shi 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.