Expression of Inflammasomes in HCV Patients

Hepatitis C Clinical Trial

— Inflammasome  

Official title:

Expression of Inflammasomes in HCV Patients Before and After Treatment

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04244383
• Other study ID #: ?AssiutU
• Status: Not yet recruiting
• Phase: Phase 4
• Start date: January 2020
• Est. completion date: July 2020

Study information

• Verified date: January 2020
• Source: Assiut University
• Contact: Khaled Mohammed Hassanein, professor
• Phone: 01118508060
• Email: khaledhassanein70[@]yahoo.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 50
• Est. completion date: July 2020
• Est. primary completion date: June 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hepatitis C

Intervention

Diagnostic Test:
• interleukin IL-1beta and interleukin IL-18
pro-inflammatory cytokines measured in the serum

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

References & Publications (5)

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. — View Citation

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. — View 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. Review. — View 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. Review. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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