NCT01389323已完成3 期
Open-Label, Single Arm Evaluation of BMS-790052 (Daclatasvir) in Combination With Peg-Interferon Alfa-2a and Ribavirin in Black-African Americans, Latinos and White-Caucasians With Chronic Hepatitis C Genotype 1 Infection
Bristol-Myers Squibb36 个研究点 分布在 2 个国家目标入组 448 人开始时间: 2011年9月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 448
- 试验地点
- 36
- 主要终点
- Percentage of Participants Achieving Sustained Virologic Response at Post-treatment Week 12 (SVR12)
研究概览
简要总结
The purpose of this study is to compare the rates of sustained virologic response in each cohort (Black-African Americans, Latinos) in this study to historical rate.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Participants chronically infected with Hepatitis C virus (HCV) genotype 1
- •HCV RNA viral load of ≥10,000 IU/mL at screening
- •No previous exposure to interferon formulation, ribavirin or HCV direct antiviral agent
- •Self-described as Black-African American, Latino or White-Caucasian
- •Results of a liver biopsy obtained ≤36 months prior to first treatment compensated cirrhotics with HCV liver biopsy from any time prior to first treatment.
- •Compensated cirrhotics were capped at approximately 25%
排除标准
- •Evidence of decompensated liver disease
- •Documented or suspected Hepatocellular carcinoma (HCC)
- •Positive for Hepatitis B or HIV 1/HIV 2 antibody at screening
研究组 & 干预措施
Arm 1: Daclatasvir + Peg-Interferon Alfa-2a + Ribavirin
Experimental
干预措施: Daclatasvir (Drug)
Arm 1: Daclatasvir + Peg-Interferon Alfa-2a + Ribavirin
Experimental
干预措施: Peg-Interferon Alfa-2a (Drug)
Arm 1: Daclatasvir + Peg-Interferon Alfa-2a + Ribavirin
Experimental
干预措施: Ribavirin (Drug)
结局指标
主要结局
Percentage of Participants Achieving Sustained Virologic Response at Post-treatment Week 12 (SVR12)
时间窗: Post-treatment Week 12
SVR12 was defined as Hepatitis C Virus (HCV) RNA levels \<lower limit of quantitation (LLOQ), (target detected or target not detected) at Post-treatment Week 12. The limit of detection for HCV RNA was 10 IU/mL and the LLOQ was 25 IU/mL. For analysis purpose, participants were assigned to following 3 race/ethnicity cohorts: Black/African American, Latino, and White non-Latino. Some participants were represented in more than one race/ethnicity cohort.
次要结局
- Percentage of Participants Achieving Sustained Virologic Response at Post-treatment Week 12 (SVR12) With rs12979860 Single Nucleotide Polymorphisms at Baseline in the Interleukin-28B Gene(Post-treatment Week 12)
- Percentage of Participants With Hepatitis C Virus (HCV) RNA Levels <Lower Limit of Quantitation (LLOQ), Target Detected or Target Not Detected, at Specified Time Points(Weeks 1, 2, 4, 6, 8, 12; both Weeks 4 and 12; end-of-treatment (up to 48 weeks), or post-treatment Week 24)
- Percentage of Participants With Hepatitis C Virus (HCV) RNA Levels <Lower Limit of Quantitation (LLOQ), Target Not Detected, at Specified Time Points(Weeks 1, 2, 4, 6, 8, 12; both Weeks 4 and 12; end-of-treatment (up to 48 weeks), or post-treatment Weeks 12 and 24)
- Number of Participants With Serious Adverse Events (SAEs), Discontinuations Due to Adverse Events (AEs), Treatment-related AEs, and Who Died(From first dose to last dose plus 7 days (treatment period [TP]) through 48 weeks after the end of TP (follow-up period [FUP]))
研究者
研究点 (36)
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