Expression of Inflammasomes in HCV Patients (Inflammasome)
Primary Purpose
Hepatitis C
Status
Unknown status
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
interleukin IL-1beta and interleukin IL-18
Sponsored by
About this trial
This is an interventional other trial for Hepatitis C
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
chronic hepatitis C virus patients
treated chronic hepatitis C virus patients
Arm Description
50 chronic hepatitis C virus patients taking will be trated with direct acting antiviral treatment with three months regimen (Sofosbuvir + Daclatasvir).
the 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).
Outcomes
Primary Outcome Measures
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).
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04244383
Brief Title
Expression of Inflammasomes in HCV Patients
Acronym
Inflammasome
Official Title
Expression of Inflammasomes in HCV Patients Before and After Treatment
Study Type
Interventional
2. Study Status
Record Verification Date
January 2020
Overall Recruitment Status
Unknown status
Study Start Date
January 2020 (Anticipated)
Primary Completion Date
June 2020 (Anticipated)
Study Completion Date
July 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Assiut University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatitis C
7. Study Design
Primary Purpose
Other
Study Phase
Phase 4
Interventional Study Model
Factorial Assignment
Model Description
chronic hepatitis C virus patients
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
chronic hepatitis C virus patients
Arm Type
Experimental
Arm Description
50 chronic hepatitis C virus patients taking will be trated with direct acting antiviral treatment with three months regimen (Sofosbuvir + Daclatasvir).
Arm Title
treated chronic hepatitis C virus patients
Arm Type
Experimental
Arm Description
the 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).
Intervention Type
Diagnostic Test
Intervention Name(s)
interleukin IL-1beta and interleukin IL-18
Intervention Description
pro-inflammatory cytokines measured in the serum
Primary Outcome Measure Information:
Title
changes in the exprssion level of inflammasomes
Description
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).
Time Frame
6 monthes
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Khaled Mohammed Hassanein, professor
Phone
01118508060
Email
khaledhassanein70@yahoo.com
First Name & Middle Initial & Last Name or Official Title & Degree
Helal Foad Hetta, lecturer
Phone
0100311412
Email
helalhetta@yahoo.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Asmaa Salah El-dien Gaber, lecturer
Organizational Affiliation
participator in the research
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Mohamed Ahmed Medhat, lecturer
Organizational Affiliation
participator in the research
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Sara Fergany Abd El-hamid, student
Organizational Affiliation
participator in the research
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
30222506
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.
Results Reference
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PubMed Identifier
20847744
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.
Results Reference
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PubMed Identifier
19238512
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.
Results Reference
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PubMed Identifier
29040318
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.
Results Reference
background
PubMed Identifier
28643186
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.
Results Reference
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Expression of Inflammasomes in HCV Patients
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