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

Hepatitis C, Chronic Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03882307
• Other study ID #: hhayam
• Status: Recruiting
• Phase: Early Phase 1
• Start date: October 2022
• Est. completion date: December 2022

Study information

• Verified date: July 2022
• Source: Assiut University
• Contact: Salwa Sayed Ahmed, proffessor
• Phone: 01013318344
• Email: salwaegy[@]yahoo.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 .

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: December 2022
• Est. primary completion date: November 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis A
• Hepatitis C
• Hepatitis C, Chronic

Intervention

Drug:
• sofosbuvir and daclatasvir
oral tablets

Locations

Country	Name	City	State
Egypt	Assiut university	Assiut

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

References & Publications (7)

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. — View Citation

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. — View Citation

Heinrich PC, Castell JV, Andus T. Interleukin-6 and the acute phase response. Biochem J. 1990 Feb 1;265(3):621-36. Review. — View Citation

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. Review. — View Citation

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. — View Citation

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. Erratum in: N Engl J Med. 2014 Apr 10;370(15):1469. — View Citation

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-a2b plus ribavirin. Antivir Ther. 2011;16(7):1081-91. doi: 10.3851/IMP1864. Erratum in: Antivir Ther. 2011;16(7):1137-8. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	mean difference in level of interleukin-6 and transforming growth factor beta after 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

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