The Pulmonary Safety of the New Oral Antihepatitis C Treatment
试验速览
- 阶段
- 不适用
- 入组人数
- 50
- 主要终点
- the pulmonary side effect of the new anti HCV medication in our population.
研究概览
简要总结
pulmonary side effects of the new regimen of antihepatitis C
详细描述
Hepatitis C is a liver disease caused by the hepatitis C virus.The hepatitis C virus is a blood borne virus The most common modes of infection are through exposure to small quantities of blood, through injection drug use, unsafe injection practices, unsafe health care, and the transfusion of unscreened blood and blood products.
An estimated 71 million people have chronic hepatitis C infection. A significant number of those who are chronically infected will develop cirrhosis and or liver cancer. the treatment of hepatitis C virus (HCV) infection has been difficult, particularly in patients with HCV genotype 1. Reasons for the difficulty include the inherent toxicity and limited efficacy of interferon-based therapy, which has been the cornerstone of anti-HCV efforts during the past 2 decades.
Newly available direct-acting antiviral agents (DAAs) have the potential to dramatically improve HCV eradication rates. Despite these new drugs has been characterized by a very low adverse events rate in the published clinical trials Few data are available on pulmonary adverse events based real life studies
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •HCV RNA positivity .
排除标准
- •Child C cirrhosis.
- •Clinically manifest liver decompensation :ascites ,encephalopathy, wasting, hepatorenal syndrome.
- •Serum albumin less than 2.8 g/dl,total serum bilirubin more than 3 mg/dl ,INR1.7 or more .
- •absolute neutrophil counts < 1500\mm3 and\or platelet less than 50,000/mm
- •HCC except 6 months after concluding intervention aiming at cure with no evidence of activity by dynamic CT or MRI.
- •Extrahepatic malignancy except after two years of disease\disease free interval
- •In lymphomas and chronic lymphatic leukemia can be initiated immediately after remission based on the treating oncologist's report
- •Pregnancy or inability to use effective contraception
- •Inadequately controlled diabetes mellitus (HbA1c>9%)
- •sever renal impairment in which creatinine clearance < 30 ml\min
- •chronic lung diseases .
研究组 & 干预措施
respiratory symptoms reported in studied patients
If Sofosbuvir\Daclatasvir regimen has respiratory side effects or not and the factors increase incidence of respiratory complications
干预措施: sofosbuvir \daclatsvir (Drug)
结局指标
主要结局
the pulmonary side effect of the new anti HCV medication in our population.
时间窗: 3 months
find out the pulmonary side effects of the new anti hepatitis C treatment (sovosbuvir based regimen )
次要结局
- the factors that increase the incidence of pulmonary complications(3 months)
研究者
Marina Omil Saman
Principle investigator
Assiut University