Effects of Direct Antiviral Agents on Hepatitis C Virus Arthropathy

Hepatitis C Clinical Trial

Official title:

Effects of Direct Antiviral Agents on Hepatitis C Virus Arthropathy

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03226717
• Other study ID #: HCVDAV
• Status: Not yet recruiting
• Phase: N/A
• First received: June 18, 2017
• Last updated: July 19, 2017
• Start date: August 10, 2017
• Est. completion date: December 10, 2017

Study information

• Verified date: July 2017
• Source: Assiut University
• Contact: yasmin M Turkey
• Phone: 01060497881
• Email: jasmin.turkey589[@]yahoo.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The prevalence of HCV infection in Egypt is 14.7%. HCV is both a hepatotropic and a lymphotropic virus, it may exert a chronic stimulus on the immune system with both T and B lymphocyte alterations. In addition to cryoglobulinaemic vasculitis, HCV may trigger different immune-mediated extrahepatic disorders. A variable combination of HCV with other unknown enviromental and/or hostgenetic cofactors may lead to different clinical phenotypes that characterise HCV syndrome. Patients who have HCV -related arthropathy are accounted for by 2 clinical subsits: Rheumatoid-like arthritis and Cryoglobulin-related arthritis. Patients with mild arthritis, conservative manegement using analgesics with anti- inflammatory activity is recommended. In patients who have contraindications to their use, short term low dose prednisone is an option. In HCV infection with concomitant RA, ACR guidelines published in 2008 provided recommendations pertaining to these of DMARDs that are based on the severity of liver disease using the child- pugh- turcotte classification. For patients with severe cryoglobulinaemia such as severe debilitating disease or systemic in improvement, a combination of immunosuppressive and antiviral therapy is preferred. It has been found that antiviral therapy with interferon immunosuppressive and antiviral therapy is preferred. It has been found that antiviral therapy with interferon improves the musculoskeletal manifestations in HCV arthropathy. The DIrect antiviral agents seems very promising in treatment of HCV arthropathy. As HCV genotype 4 is the most common genotype in Egypt, the effective optional antiviral agents are sofosbuvir, daclatasvir, ledipasvir, paritaprevir, velpatasvir, ombitasvir and simeprevir.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: December 10, 2017
• Est. primary completion date: September 10, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

• Antiviral patients with arthropathy concomitant HCV (proved by PCR testing).

Exclusion Criteria:

• patients with child-pugh B and child-pugh C decompensated cirrhosis.

• patients more that 60 years.

• patients with chronic infection e.g.(pulmonary T.B).

• patients with organ failure e.g.( heart failure, respiratory failure).

• patients with CKD with GFR lead that 60 ml/ ministry/1.73m2.

• patients on immunosuppressive agents.

• patients with HBV- coinfection.

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis A
• Hepatitis C
• Joint Diseases

Intervention

Drug:
• Antiviral agents
combination therapy consists of Sofosbuvir,daclatasvir and ribavirin

Locations

Country	Name	City	State
Egypt	yasmin AbdElazim Mohamed Turkey	Assiut

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	rate of Improvement of manifestations of arthropathy	Improvement of manifestations of arthropathy in hepatitis C patients after treatment by assessment through pain scale	3_6 months

External Links

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