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临床试验/NCT03226717
NCT03226717Unknown不适用

Effects of Direct Antiviral Agents on Hepatitis C Virus Arthropathy

Assiut University1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2017年8月10日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
入组人数
100
试验地点
1
主要终点
rate of Improvement of manifestations of arthropathy

研究概览

简要总结

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

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

排除标准

  • 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/1.73m
  • patients on immunosuppressive agents.
  • patients with HBV- coinfection.

研究组 & 干预措施

Hepatitis C patients

Antiviral agents (sofosbuvir,daclatasvir,ribavirin) will be given to hepatitis C patients with arthropathy.

干预措施: Antiviral agents (Drug)

结局指标

主要结局

rate of Improvement of manifestations of arthropathy

时间窗: 3_6 months

Improvement of manifestations of arthropathy in hepatitis C patients after treatment by assessment through pain scale

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Yasmin abd elazim mohamed turkey

principle investigator.

Assiut University

研究点 (1)

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