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Effects of Direct Antiviral Agents on Hepatitis C Virus Arthropathy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03226717
Recruitment Status : Not yet recruiting
First Posted : July 24, 2017
Last Update Posted : July 24, 2017
Information provided by (Responsible Party):
Yasmin abd elazim mohamed turkey, Assiut University

Brief 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.

Condition or disease Intervention/treatment
Hepatitis C Drug: Antiviral agents

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Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Effects of Direct Antiviral Agents on Hepatitis C Virus Arthropathy
Estimated Study Start Date : August 10, 2017
Estimated Primary Completion Date : September 10, 2017
Estimated Study Completion Date : December 10, 2017

Resource links provided by the National Library of Medicine

Group/Cohort Intervention/treatment
Hepatitis C patients
Antiviral agents (sofosbuvir,daclatasvir,ribavirin) will be given to hepatitis C patients with arthropathy.
Drug: Antiviral agents
combination therapy consists of Sofosbuvir,daclatasvir and ribavirin

Primary Outcome Measures :
  1. rate of Improvement of manifestations of arthropathy [ Time Frame: 3_6 months ]
    Improvement of manifestations of arthropathy in hepatitis C patients after treatment by assessment through pain scale

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
patients with hepatitis C virus

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.

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 identifier (NCT number): NCT03226717

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Contact: yasmin M Turkey 01060497881

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yasmin AbdElazim Mohamed Turkey Recruiting
Assiut, Egypt
Sponsors and Collaborators
Assiut University

Additional Information:
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Responsible Party: Yasmin abd elazim mohamed turkey, principle investigator., Assiut University Identifier: NCT03226717     History of Changes
Other Study ID Numbers: HCVDAV
First Posted: July 24, 2017    Key Record Dates
Last Update Posted: July 24, 2017
Last Verified: July 2017

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Additional relevant MeSH terms:
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Hepatitis A
Hepatitis C
Joint Diseases
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections
Musculoskeletal Diseases
Antiviral Agents
Anti-Infective Agents