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

July 25, 2022 updated by: Hayam Hamdy Mahmoud, Assiut University

Association of Serum Interleukin -6 and Transforming Growth Factor Beta Levels With Response to Antiviral Therapy for Chronic Hepatitis c Patients

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 .

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: group1 (naive)
Assess serum level of interleukin-6 and transforming growth factor beta before the course of treatment
Active Comparator: group2 (sustained responder)
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
Drug: sofosbuvir and daclatasvir
oral tablets
Other Names:
  • Sovaldi

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
mean difference in level of interleukin-6 and transforming growth factor beta after treatment
Time Frame: three months from the end of treatment
serum level of interleukin-6 and transforming growth factor beta will be measured before and after treatment
three months from the end of treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Investigators

  • Principal Investigator: hayam hamdy, master deree, faculty of medicine,medical microbiology department

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

October 1, 2022

Primary Completion (Anticipated)

November 1, 2022

Study Completion (Anticipated)

December 1, 2022

Study Registration Dates

First Submitted

March 15, 2019

First Submitted That Met QC Criteria

March 17, 2019

First Posted (Actual)

March 20, 2019

Study Record Updates

Last Update Posted (Actual)

July 26, 2022

Last Update Submitted That Met QC Criteria

July 25, 2022

Last Verified

July 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • hhayam

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Serum concentrations of(IL-6 and TGF-β) will be measured before treatment and after three months from the end of the course of treatment with sofosbuvir 400 mg once daily plus daclatasvir 60 mg for three months using a commercially available Quanti kine ELISA (Enzyme linked Immune sorbent Assay ).

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Locations

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