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 : March 21, 2019
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|
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 (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|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)|
|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 :||May 1, 2019|
|Estimated Primary Completion Date :||November 1, 2019|
|Estimated Study Completion Date :||December 30, 2019|
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
Other Name: Sovaldi
- 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
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
|Contact: Salwa Sayed Ahmed, firstname.lastname@example.org|
|Contact: Aliaa Mahmoud Ali, email@example.com|
|Principal Investigator:||hayam hamdy, master deree||faculty of medicine,medical microbiology department|