Expression of Inflammasomes in HCV Patients

Phase 4

• Conditions: Hepatitis C
• Interventions: Diagnostic Test: interleukin IL-1beta and interleukin IL-18

• Registration Number: NCT04244383
• Lead Sponsor: Assiut University

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2020-01
• Study Start: 2020-01
• Study First Submitted: 2020-01-22
• Study First Submitted QC: 2020-01-24
• Last Update Submitted: 2020-01-24
• Study First Posted: 2020-01-28
• Last Update Posted: 2020-01-28
• Primary Completion: 2020-06
• Study Completion: 2020-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
treated chronic hepatitis C virus patients	interleukin IL-1beta and interleukin IL-18	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).
chronic hepatitis C virus patients	interleukin IL-1beta and interleukin IL-18	50 chronic hepatitis C virus patients taking will be trated with direct acting antiviral treatment with three months regimen (Sofosbuvir + Daclatasvir).

Primary Outcome Measures

Name	Time	Method
changes in the exprssion level of inflammasomes	6 monthes	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).