Levels of Interleukin-6 andTransforming Growth Factor Beta in HCV Patients Sera
NCT ID: NCT03882307
Last Updated: 2022-07-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
EARLY_PHASE1
40 participants
INTERVENTIONAL
2022-10-31
2022-12-31
Brief Summary
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Egypt has possibly the highest HCV prevalence in the world, 10-20% of the general population .
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
DOUBLE
Study Groups
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group1 (naive)
Assess serum level of interleukin-6 and transforming growth factor beta before the course of treatment
No interventions assigned to this group
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
sofosbuvir and daclatasvir
oral tablets
Interventions
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sofosbuvir and daclatasvir
oral tablets
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* HCV RNA positivity .
* Any Body Mass Index(BMI).
* Treatment-naive or treatment experienced.
* all fibrosis stages.
Exclusion Criteria
* 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.
18 Years
70 Years
ALL
No
Sponsors
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Assiut University
OTHER
Responsible Party
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Hayam Hamdy Mahmoud
principle investigator
Principal Investigators
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hayam hamdy, master deree
Role: PRINCIPAL_INVESTIGATOR
faculty of medicine,medical microbiology department
Locations
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Assiut university
Asyut, , Egypt
Countries
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Central Contacts
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Facility Contacts
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References
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Rahman El-Zayadi A, Abaza H, Shawky S, Mohamed MK, Selim OE, Badran HM. Prevalence and epidemiological features of hepatocellular carcinoma in Egypt-a single center experience. Hepatol Res. 2001 Feb;19(2):170-179. doi: 10.1016/s1386-6346(00)00105-4.
Sulkowski MS, Gardiner DF, Rodriguez-Torres M, Reddy KR, Hassanein T, Jacobson I, Lawitz E, Lok AS, Hinestrosa F, Thuluvath PJ, Schwartz H, Nelson DR, Everson GT, Eley T, Wind-Rotolo M, Huang SP, Gao M, Hernandez D, McPhee F, Sherman D, Hindes R, Symonds W, Pasquinelli C, Grasela DM; AI444040 Study Group. Daclatasvir plus sofosbuvir for previously treated or untreated chronic HCV infection. N Engl J Med. 2014 Jan 16;370(3):211-21. doi: 10.1056/NEJMoa1306218.
Baskic D, Vukovic VR, Popovic S, Djurdjevic P, Zaric M, Nikolic I, Zelen I, Mitrovic M, Avramovic D, Mijailovic Z. Cytokine profile in chronic hepatitis C: An observation. Cytokine. 2017 Aug;96:185-188. doi: 10.1016/j.cyto.2017.04.008. Epub 2017 Apr 21.
Heinrich PC, Castell JV, Andus T. Interleukin-6 and the acute phase response. Biochem J. 1990 Feb 1;265(3):621-36. doi: 10.1042/bj2650621. No abstract available.
Ueyama M, Nakagawa M, Sakamoto N, Onozuka I, Funaoka Y, Watanabe T, Nitta S, Kiyohashi K, Kitazume A, Murakawa M, Nishimura-Sakurai Y, Sekine-Osajima Y, Itsui Y, Azuma S, Kakinuma S, Watanabe M; Ochanomizu-Liver Conference Study Group. Serum interleukin-6 levels correlate with resistance to treatment of chronic hepatitis C infection with pegylated-interferon-alpha2b plus ribavirin. Antivir Ther. 2011;16(7):1081-91. doi: 10.3851/IMP1864.
Bissell DM, Wang SS, Jarnagin WR, Roll FJ. Cell-specific expression of transforming growth factor-beta in rat liver. Evidence for autocrine regulation of hepatocyte proliferation. J Clin Invest. 1995 Jul;96(1):447-55. doi: 10.1172/JCI118055.
Liaskou E, Wilson DV, Oo YH. Innate immune cells in liver inflammation. Mediators Inflamm. 2012;2012:949157. doi: 10.1155/2012/949157. Epub 2012 Aug 9.
Related Links
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related info
Other Identifiers
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hhayam
Identifier Type: -
Identifier Source: org_study_id
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