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
- 入组人数
- 250
- 试验地点
- 21
- 主要终点
- Incidence of adverse events
研究概览
简要总结
This is a phase-IV multicenter, prospective, open label single arm study designed to determine the safety & efficacy of Sofosbuvir/Daclatasvir fixed dose combination in adult Indian patients with confirmed chronic HCV genotype 3 infection.
The Primary objective of the study - To assess the safety and tolerabilitThis is a phase-IV multicenter, prospective, open label single arm study designed to determine the safety & efficacy of Sofosbuvir/Daclatasvir fixed dose combination in adult Indian patients with confirmed chronic HCV genotype 3 infection. The Primary objective of the study - To assess the safety and tolerability of Sofosbuvir/Daclatasvir FDC in adults with Chronic HCV genotype 3 infection.
The Secondary objective of the study - To determine the efficacy of fixed dose combination (FDC) of Sofosbuvir/Daclatasvir in adults with Chronic HCV Genotype 3 infection, as measured by the sustained virologic response rates at 12 weeks (SVR12) after End of Treatmenty of Sofosbuvir/Daclatasvir FDC in adults with Chronic HCV genotype 3 infection.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Willing and able to provide written informed consent
- •Male or female, age equal to or greater than 18 to equal to or less than 65 years
- •Confirmed chronic HCV genotype 3 infection
- •Eligible to receive sofosbuvir/ daclatasvir fixed dose combination in HCV genotype 3.
排除标准
- •Pregnant or nursing female or male with pregnant female partner not willing to use adequate physical barrier.
- •Chronic liver disease of a non-HCV etiology
- •Known coinfection with hepatitis B virus (HBV) and/or human immunodeficiency virus (HIV)
- •Documented or suspected Hepatocellular Carcinoma (HCC)
- •Evidence of liver cirrhosis
- •Patients with adequate hemoglobin levels
- •Patients with impaired renal function
- •Patients on Medicinal products which are contraindicated to be used with sofosbuvir/ daclatasvir based combination therapy
- •History of significant pulmonary disease, significant cardiac disease or porphyria.
结局指标
主要结局
Incidence of adverse events
时间窗: Treatment period and up to 4 weeks after EOT
次要结局
- 1. Percentage of subjects having the Sustained Virological Response i.e. virological response measured at SVR12 Visit(12 weeks after the End of Treatment)