Expression of Inflammasomes in HCV Patients

Assiut University

Status and phase: Unknown; Phase 4

Conditions: Hepatitis C

Treatments: Diagnostic Test: interleukin IL-1beta and interleukin IL-18

Study type: Interventional

Funder types: Other

Identifiers

NCT04244383

ِAssiutU

Details and patient eligibility

About

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.

Enrollment: 50 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts 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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: None (Open label)

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50 participants in 2 patient groups

chronic hepatitis C virus patients

Experimental group

Description:

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

Treatment:

Diagnostic Test: interleukin IL-1beta and interleukin IL-18

treated chronic hepatitis C virus patients

Experimental group

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).

Treatment:

Diagnostic Test: interleukin IL-1beta and interleukin IL-18