Levels of Interleukin-6 andTransforming Growth Factor Beta in HCV Patients Sera

Early Phase 1

• Conditions: Hepatitis C, Chronic
• Interventions: Drug: sofosbuvir and daclatasvir

• Registration Number: NCT03882307
• Lead Sponsor: Assiut University

Brief Summary

Hepatitis C virus (HCV) infection is associated with significant morbidity and mortality owing to progression of a high percentage (85%) of HCV infected patients to chronic hepatitis, which might lead to the development of liver cirrhosis or hepato cellular carcinoma..

Egypt has possibly the highest HCV prevalence in the world, 10-20% of the general population .

Detailed Description

Currently, second-generation direct-acting antiviral agents have been used for chronic hepatitis C treatment. The association of sofosbuvir with daclatasvir or simeprevir , with or without ribavirin , directly inhibits viral replication .

Sofosbuvir (400 mg once per day) and daclatasvir (60mg once per day) or simeprevir (150 mg once per day) for 3 months treatment regimens.

Sofosbuvir-based antiviral therapy guarantees efficacy in HCV eradication in approximately 90% of cases and is associated with mild to moderate adverse effects.

Overall, studies describe an increase in serum cytokine levels in chronic hepatitis C patients, when compared with healthy individuals. ,interleukin-6(IL-6) is produced mainly by kupffer cells and induces the production of the acute phase proteins, C-reactive protein and haptoglobin .

Previous studies reported that serum Interleukin-6 levels were increased, compared with healthy individuals, in patients with some liver diseases.Previous results suggest that baseline levels of Interleukin, as well as their decrease during treatment .Transforming growth factor beta (TGF-β) is a cytokine that has been assigned a key role in epithelial repair. Injury to the liver elicits a rapid increase in its expression. HCV -infected hepatocytes produce (TGF-β) which may stimulate T-regulatory cells.

Study Timeline

• Study First Submitted: 2019-03-15
• Study First Submitted QC: 2019-03-17
• Study First Posted: 2019-03-20
• Status Verified: 2022-07
• Last Update Submitted: 2022-07-25
• Last Update Posted: 2022-07-26
• Study Start: 2022-10
• Primary Completion: 2022-11
• Study Completion: 2022-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• Age from 18 to 70 years.
• HCV RNA positivity .
• Any Body Mass Index(BMI).
• Treatment-naive or treatment experienced.
• all fibrosis stages.

Exclusion criteria:

• Direct serum bilirubin greater than 2 mg/dl.
• Serum albumin less than 2.8 g/dl.
• International normalization ratio (INR) greater than or equal to 1.7
• Platelet count less than 50 000/mm3.
• Ascites or history of ascites.
• Hepatic encephalopathy or history of hepatic encephalopathy.
• Hepatocellular carcinoma.
• Serum creatinine greater than 2.5 mg/dl .
• Pregnancy.

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
group2 (sustained responder)	sofosbuvir and daclatasvir	Assess serum level of interleukin-6 and transforming growth factor beta after three months from the end of treatment Sofosbuvir (SOF) (400 mg once per day) and daclatasvir (DCV)(60mg once per day) or simeprevir (SIM) (150 mg once per day) for 3 months treatment regimens

Primary Outcome Measures

Name	Time	Method
mean difference in level of interleukin-6 and transforming growth factor beta after treatment	three months from the end of treatment	serum level of interleukin-6 and transforming growth factor beta will be measured before and after treatment

Trial Locations

Locations (1)

Assiut university; 🇪🇬 Assiut, Egypt