A Phase 3 Randomized, Double Blind, Multi-National Evaluation of Daclatasvir in Combination With Peg Interferon Alfa-2a and Ribavirin in Treatment-Naive Subjects With Chronic Hepatitis C Genotypes 1 and 4
试验速览
- 阶段
- 3 期
- 状态
- 撤回
- 发起方
- 主要终点
- Proportion of Genotype 1 subjects with SVR24, defined as HCV RNA < Limit of quantification (LOQ) at follow-up Week 24 for each cohort
研究概览
简要总结
The purpose of this study is to determine whether 24 week treatment with the Daclatasvir (DCV) in combination with Pegylated-interferon alfa 2a (pegIFNα-2a) and Ribavirin (RBV) is safe and demonstrates rate of Sustained Virologic Response at follow up week 24 (SVR24) (defined as undetectable HCV RNA at post-treatment Week 24) that are non-inferior to 48 weeks of the dual combination therapy of pegIFNα-2a/RBV in a majority of study subjects
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Patients chronically infected with Hepatitis C virus (HCV) GT 1 or 4
- •HCV RNA viral load ≥ 10,000 IU/mL
- •Naïve to prior treatment with any interferon formulation, Ribavirin (RBV) or HCV direct antiviral agent
- •Patients with compensated cirrhosis are permitted
排除标准
- •Infected with HCV other than GT 1 or 4
- •Evidence of decompensated liver disease
- •Documented or suspected Hepatocellular carcinoma (HCC) as evidenced by previously obtained imaging studies or liver biopsy
- •Evidence of a medical condition contributing to chronic liver disease other than HCV
- •History of chronic Hepatitis B virus (HBV) or Human immunodeficiency virus (HIV)
- •Current or know history of cancer (except in situ carcinoma of cervix or adequately treated basal or squamous cell carcinoma of the skin) within 5 years prior to enrollment
- •Laboratory values:
- •Hemoglobin < 12 g/dL (females) or < 13 g/dL (males)
- •Platelets < 90 x 1000000000 cells/L
- •Absolute neutrophil count (ANC) < 1.5 × 1000000000 cells/L
- •Total bilirubin ≥ 34 µmol/L (unless due to Gilbert's disease)
研究组 & 干预措施
pegIFNα 2a + Ribavirin + Placebo
pegIFNα 2a 180 µg, Solution for injection, Subcutaneous, Once weekly, 48 weeks
Ribavirin 200 mg Tablets, by mouth, 400-600mg AM, 600 mg PM, 48 weeks
Placebo 0 mg Tablets, by mouth, Once daily, 24 weeks
干预措施: Peginterferon alfa 2a (Drug)
pegIFNα 2a + Ribavirin + Placebo
pegIFNα 2a 180 µg, Solution for injection, Subcutaneous, Once weekly, 48 weeks
Ribavirin 200 mg Tablets, by mouth, 400-600mg AM, 600 mg PM, 48 weeks
Placebo 0 mg Tablets, by mouth, Once daily, 24 weeks
干预措施: Ribavirin (Drug)
pegIFNα 2a + Ribavirin + Placebo
pegIFNα 2a 180 µg, Solution for injection, Subcutaneous, Once weekly, 48 weeks
Ribavirin 200 mg Tablets, by mouth, 400-600mg AM, 600 mg PM, 48 weeks
Placebo 0 mg Tablets, by mouth, Once daily, 24 weeks
干预措施: Placebo matching Daclatasvir (Drug)
pegIFNα 2a + Ribavirin + Daclatasvir
pegIFNα 2a 180 µg, Solution for injection, Subcutaneous, Once weekly, 24 or 48 weeks depending on response
Ribavirin 1000-1200 mg Tablets, by mouth, 400-600mg AM, 600 mg PM, 24 or 48 weeks depending on response
Daclatasvir 60 mg Tablets, by mouth, Once daily, 24 weeks
干预措施: Peginterferon alfa 2a (Drug)
pegIFNα 2a + Ribavirin + Daclatasvir
pegIFNα 2a 180 µg, Solution for injection, Subcutaneous, Once weekly, 24 or 48 weeks depending on response
Ribavirin 1000-1200 mg Tablets, by mouth, 400-600mg AM, 600 mg PM, 24 or 48 weeks depending on response
Daclatasvir 60 mg Tablets, by mouth, Once daily, 24 weeks
干预措施: Ribavirin (Drug)
pegIFNα 2a + Ribavirin + Daclatasvir
pegIFNα 2a 180 µg, Solution for injection, Subcutaneous, Once weekly, 24 or 48 weeks depending on response
Ribavirin 1000-1200 mg Tablets, by mouth, 400-600mg AM, 600 mg PM, 24 or 48 weeks depending on response
Daclatasvir 60 mg Tablets, by mouth, Once daily, 24 weeks
干预措施: Daclatasvir (Drug)
结局指标
主要结局
Proportion of Genotype 1 subjects with SVR24, defined as HCV RNA < Limit of quantification (LOQ) at follow-up Week 24 for each cohort
时间窗: Week 24 post treatment follow up
次要结局
- Proportion of Genotype (GT) 4 subjects with SVR24(Week 24 post treatment follow up visit)
- Proportion of GT 1 & 4 subjects who achieve HCV RNA < LOQ or undetectable(Week 24 post treatment follow up visit and Week 48 post treatment follow up visit for subjects who achieve Virologic response [VR] (4&12))
- Frequency of Serious Adverse Events (SAEs)/discontinuations due to Adverse Events (AEs)(Up to 48 weeks plus 30 days)
- Discontinuations due to Adverse Events (AEs)(Up to 48 weeks plus 7 days)
- Proportion of subjects with Sustained Virologic Response at follow up week 12 (SVR12) or SVR24 by rs12979860 Single nucleotide polymorphism (SNP) in the IL28B gene(Up to 72 weeks)