A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of ABT-450/Ritonavir/ABT-267 (ABT-450/r/ABT-267) and ABT-333 in Treatment-Naïve and Treatment-Experienced, Non-Cirrhotic Asian Adults With Subgenotype 1b Chronic Hepatitis C Virus (HCV) Infection
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 650
- 主要终点
- Percentage of Participants With Sustained Virologic Response 12 Weeks Post-treatment (SVR12)
研究概览
简要总结
This is a study to evaluate ABT 450/r/ABT-267 and ABT-333 in treatment-naïve and treatment-experienced Asian adults with subgenotype 1b chronic HCV without cirrhosis.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Chinese, South Korean, and Taiwanese descent with full Chinese, South Korean, and Taiwanese parentage
- •Chronic hepatitis C virus (HCV) infection prior to study enrollment.
- •Screening laboratory result indicating HCV subtype 1b (GT1b) infection.
- •Per local standard practice, documented absence of cirrhosis.
- •Participant has never received antiviral treatment (including interferon [IFN]-based therapy [alpha, beta or pegylated (peg)IFN] with or without RBV) for HCV infection (treatment-naïve participant) or participant must have documentation that they met the definition of one of the following categories (treatment experienced participant): Non-responder or Relapser
- •Participant has plasma HCV RNA level > 10,000 IU/mL at Screening.
排除标准
- •HCV genotype performed during screening indicating unable to genotype or infection with any HCV genotype other than GT1b.
- •Positive test result at Screening for hepatitis B surface antigen (HBsAg), or hepatitis B virus DNA (HBV-DNA) > Lower Limit of Quantification (LLOQ) if HBsAg negative, or anti-human immunodeficiency virus antibody (HIV Ab) positive.
- •Any current or past clinical evidence of cirrhosis.
- •Any primary cause of liver disease other than chronic HCV infection.
- •Screening laboratory analyses showing abnormal kidney, hepatic, or hematologic function.
- •Use of known strong inducers of cytochrome P450 3A (CYP3A) or strong inhibitors of cytochrome P450 3A (CYP2C8) within 2 weeks or within 10 half-lives, whichever is longer, of the respective medication/supplement prior to study drug administration.
研究组 & 干预措施
Double-blind 3-DAA
Double-blind 3-DAA (ombitasvir/paritaprevir/ritonavir [25 mg/150 mg/100 mg once daily] and dasabuvir [250 mg twice daily]) for 12 weeks.
干预措施: ombitasvir/paritaprevir/ritonavir and dasabuvir (Drug)
Double-blind Placebo Followed by Open-label 3-DAA
Double-blind placebo for 12 weeks, followed by open-label 3-DAA (ombitasvir/paritaprevir/ritonavir [25 mg/150 mg/100 mg once daily] and dasabuvir [250 mg twice daily]) for 12 weeks.
干预措施: ombitasvir/paritaprevir/ritonavir and dasabuvir (Drug)
Double-blind Placebo Followed by Open-label 3-DAA
Double-blind placebo for 12 weeks, followed by open-label 3-DAA (ombitasvir/paritaprevir/ritonavir [25 mg/150 mg/100 mg once daily] and dasabuvir [250 mg twice daily]) for 12 weeks.
干预措施: Placebo for ombitasvir/paritaprevir/ritonavir and dasabuvir (Drug)
结局指标
主要结局
Percentage of Participants With Sustained Virologic Response 12 Weeks Post-treatment (SVR12)
时间窗: 12 weeks after the last actual dose of active study drug
SVR12 was defined as plasma hepatitis C virus ribonucleic acid (HCV RNA) level less than the lower limit of quantification \[\<LLOQ\]) 12 weeks after the last dose of active study drug. The primary efficacy endpoint was superiority of the percentage of treatment-naïve and treatment-experienced HCV subgenotype 1b (GT1b)-infected participants treated with 3-DAA (ombitasvir/paritaprevir/ritonavir \[25 mg/150 mg/100 once daily\] and dasabuvir \[250 mg twice daily\]) who achieved SVR12 compared with the historical control rate for comparable patients treated with telaprevir (TVR) plus pegylated interferon (pegIFN) and RBV.
Percentage of Participants With Sustained Virologic Response 24 Weeks Post-treatment (SVR24)
时间窗: 24 weeks after the last actual dose of active study drug
SVR24 was defined as plasma hepatitis C virus ribonucleic acid (HCV RNA) level less than the lower limit of quantification \[\<LLOQ\]) 12 weeks after the last dose of active study drug. The primary efficacy endpoint was superiority of the percentage of treatment-naïve and treatment-experienced HCV subgenotype 1b (GT1b)-infected participants treated with 3-DAA (ombitasvir/paritaprevir/ritonavir \[25 mg/150 mg/100 once daily\] and dasabuvir \[250 mg twice daily\]) who achieved SVR24 compared with the historical control rate for comparable patients treated with telaprevir (TVR) plus pegylated interferon (pegIFN) and RBV.
次要结局
- Percentage of Participants With On-treatment Virologic Failure(up to 12 weeks)
- Percentage of Participants With Post-treatment Relapse by Post-treatment Week 12(From the end of treatment through 12 weeks after the last dose of active study drug)
- Percentage of Participants With Post-treatment Relapse by Post-treatment Week 24(From the end of treatment through 24 weeks after the last dose of active study drug)