CTRI/2019/12/022216尚未招募4 期
Multicenter, Open Label, Prospective Phase IV Study to Evaluate the Safety and Efficacy of Fixed Dose Combination (FDC) of Sofosbuvir/Daclatasvir in Adults with Genotype 3 Chronic Hepatitis C Virus Infection in India
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Pms
入排标准
入选标准
- •1. Willing and able to provide written informed consent
- •2. Male or female, age equal to or greater than 18 to equal to or less than 65 years
- •3. Confirmed chronic HCV genotype 3 infection
- •4. Eligible to receive sofosbuvir/ daclatasvir fixed dose combination in HCV genotype 3
排除标准
- •1. Pregnant or nursing female or male with pregnant female partner not willing to use adequate physical barrier.
- •2. Chronic liver disease of a non-HCV etiology
- •3. Known coinfection with hepatitis B virus (HBV) and/or human immunodeficiency virus (HIV)
- •4. Documented or suspected Hepatocellular Carcinoma (HCC)
- •5. Evidence of liver cirrhosis
- •6. Patients with adequate hemoglobin levels
- •7. Patients with impaired renal function
- •8. Patients on Medicinal products which are contraindicated to be used with sofosbuvir/ daclatasvir based combination therapy
- •9. History of significant pulmonary disease, significant cardiac disease or porphyria.
研究者
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