Expression of Inflammasomes in HCV Patients

NCT ID: NCT04244383

Last Updated: 2020-01-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-01-31

Study Completion Date

2020-07-31

Brief Summary

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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.

Detailed Description

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Conditions

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Hepatitis C

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

chronic hepatitis C virus patients
Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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chronic hepatitis C virus patients

50 chronic hepatitis C virus patients taking will be trated with direct acting antiviral treatment with three months regimen (Sofosbuvir + Daclatasvir).

Group Type EXPERIMENTAL

interleukin IL-1beta and interleukin IL-18

Intervention Type DIAGNOSTIC_TEST

pro-inflammatory cytokines measured in the serum

treated chronic hepatitis C virus patients

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).

Group Type EXPERIMENTAL

interleukin IL-1beta and interleukin IL-18

Intervention Type DIAGNOSTIC_TEST

pro-inflammatory cytokines measured in the serum

Interventions

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interleukin IL-1beta and interleukin IL-18

pro-inflammatory cytokines measured in the serum

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Assiut University

OTHER

Sponsor Role lead

Responsible Party

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Aya Fergany

princible inverstigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Asmaa Salah El-dien Gaber, lecturer

Role: PRINCIPAL_INVESTIGATOR

participator in the research

Mohamed Ahmed Medhat, lecturer

Role: PRINCIPAL_INVESTIGATOR

participator in the research

Sara Fergany Abd El-hamid, student

Role: PRINCIPAL_INVESTIGATOR

participator in the research

Central Contacts

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Khaled Mohammed Hassanein, professor

Role: CONTACT

01118508060

Helal Foad Hetta, lecturer

Role: CONTACT

0100311412

References

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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.

Reference Type BACKGROUND
PMID: 30222506 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 20847744 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19238512 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 29040318 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 28643186 (View on PubMed)

Other Identifiers

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ِAssiutU

Identifier Type: -

Identifier Source: org_study_id

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