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

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ClinicalTrials.gov Identifier: NCT03882307
Recruitment Status : Not yet recruiting
First Posted : March 20, 2019
Last Update Posted : July 16, 2019
Sponsor:
Information provided by (Responsible Party):
Hayam Hamdy Mahmoud, 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 .


Condition or disease Intervention/treatment Phase
Hepatitis C, Chronic Drug: sofosbuvir and daclatasvir Early Phase 1

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: assess serum level of interleukin-6 and transforming growth factor beta before intervention and after intervention with sofosbuvir and daclatasvir.
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Association of Serum Interleukin -6 and Transforming Growth Factor Beta Levels With Response to Antiviral Therapy for Chronic Hepatitis c Patients
Estimated Study Start Date : October 2019
Estimated Primary Completion Date : March 2020
Estimated Study Completion Date : June 2020

Resource links provided by the National Library of Medicine


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 Name: Sovaldi




Primary Outcome Measures :
  1. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03882307


Contacts
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Contact: Salwa Sayed Ahmed, proffessor 01013318344 salwaegy@yahoo.com
Contact: Aliaa Mahmoud Ali, lecturer 01006199196 aliaaghandour@yahoo.com

Sponsors and Collaborators
Assiut University
Investigators
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Principal Investigator: hayam hamdy, master deree faculty of medicine,medical microbiology department

Additional Information:
Publications:

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Responsible Party: Hayam Hamdy Mahmoud, principle investigator, Assiut University
ClinicalTrials.gov Identifier: NCT03882307     History of Changes
Other Study ID Numbers: hhayam
First Posted: March 20, 2019    Key Record Dates
Last Update Posted: July 16, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
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 ).

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Hayam Hamdy Mahmoud, Assiut University:
hepatitis C virus therapy
interleukin-6
transforming growth factor -beta
sustained virological response

Additional relevant MeSH terms:
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Hepatitis
Hepatitis A
Hepatitis C
Hepatitis C, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections
Hepatitis, Chronic
Mitogens
Sofosbuvir
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antiviral Agents
Anti-Infective Agents