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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
Assiut University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Hepatitis C

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

    First Posted
    January 22, 2020
    Last Updated
    January 24, 2020
    Sponsor
    Assiut University
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    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
    background
    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
    background
    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
    background
    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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