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Effects of Direct Antiviral Agents on Hepatitis C Virus Arthropathy

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ClinicalTrials.gov Identifier: NCT03226717
Recruitment Status : 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

Tracking Information
First Submitted Date June 18, 2017
First Posted Date July 24, 2017
Last Update Posted Date July 24, 2017
Estimated Study Start Date August 10, 2017
Estimated Primary Completion Date September 10, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: July 19, 2017)
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
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Effects of Direct Antiviral Agents on Hepatitis C Virus Arthropathy
Official Title Effects of Direct Antiviral Agents on Hepatitis C Virus Arthropathy
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.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population patients with hepatitis C virus
Condition Hepatitis C
Intervention Drug: Antiviral agents
combination therapy consists of Sofosbuvir,daclatasvir and ribavirin
Study Groups/Cohorts Hepatitis C patients
Antiviral agents (sofosbuvir,daclatasvir,ribavirin) will be given to hepatitis C patients with arthropathy.
Intervention: Drug: Antiviral agents
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Not yet recruiting
Estimated Enrollment
 (submitted: July 19, 2017)
100
Original Estimated Enrollment Same as current
Estimated Study Completion Date December 10, 2017
Estimated Primary Completion Date September 10, 2017   (Final data collection date for primary outcome measure)
Eligibility 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.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 60 Years   (Adult)
Accepts Healthy Volunteers No
Contacts
Contact: yasmin M Turkey 01060497881 jasmin.turkey589@yahoo.com
Listed Location Countries Egypt
Removed Location Countries  
 
Administrative Information
NCT Number NCT03226717
Other Study ID Numbers HCVDAV
Has Data Monitoring Committee No
U.S. FDA-regulated Product
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
IPD Sharing Statement Not Provided
Responsible Party Yasmin abd elazim mohamed turkey, Assiut University
Study Sponsor Assiut University
Collaborators Not Provided
Investigators Not Provided
PRS Account Assiut University
Verification Date July 2017