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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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03226717
Recruitment Status : Unknown
Verified July 2017 by Yasmin abd elazim mohamed turkey, Assiut University.
Recruitment status was:  Not yet recruiting
First Posted : July 24, 2017
Last Update Posted : July 24, 2017
Sponsor:
Information provided by (Responsible Party):
Yasmin abd elazim mohamed turkey, Assiut University

Study Description
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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

Study Design
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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


Groups and Cohorts
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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


Outcome Measures
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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


Eligibility Criteria
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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
Criteria

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.
Contacts and Locations
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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 ClinicalTrials.gov identifier (NCT number): NCT03226717


Contacts
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Contact: yasmin M Turkey 01060497881 jasmin.turkey589@yahoo.com

Locations
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Egypt
yasmin AbdElazim Mohamed Turkey
Assiut, Egypt
Sponsors and Collaborators
Assiut University
More Information
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Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
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Responsible Party: Yasmin abd elazim mohamed turkey, principle investigator., Assiut University
ClinicalTrials.gov Identifier: NCT03226717    
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
Hepatitis
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Infections
 Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Blood-Borne Infections
Communicable Diseases
Flaviviridae Infections
Musculoskeletal Diseases
Antiviral Agents
Anti-Infective Agents