An Open-Label, Multicenter Study to Evaluate the Efficacy and Safety of Ombitasvir/Paritaprevir/Ritonavir and Dasabuvir With Low-Dose Ribavirin QD in Subjects With Genotype 1a Chronic Hepatitis C Virus Infection (GEODE II)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 105
- 主要终点
- Mean Change in Hemoglobin Values From Baseline to End of Treatment
研究概览
简要总结
This study seeks to assess the safety and efficacy of treatment with ombitasvir/paritaprevir/ritonavir and dasabuvir with low-dose ribavirin in non-cirrhotic, genotype 1a (GT1a) hepatitis C virus infected participants who are treatment-naïve or treatment-experienced with Interferon (IFN) or Pegylated Interferon (pegIFN) with or without Ribavirin (RBV).
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
- •Chronic hepatitis C virus (HCV) infection
- •Non-cirrhotic subjects
- •Screening laboratory results showing HCV Genotype 1a (HCV GT1a) infection
- •HCV treatment-naïve or if treated previously, only with interferon (IFN) or pegylated interferon (pegINF) with or without ribavirin (RBV)
排除标准
- •Pregnant or breastfeeding women
- •Positive for hepatitis B surface antigen (HBsAg) or anti-human immunodeficiency virus antibody (HIV Ab)
- •HCV genotype of any subtype other than GT1a or unable to subtype
- •Prior or current use of any investigational or commercially available anti-HCV agents other than IFN, pegIFN or RBV. Subjects with previous participation in trials of investigational direct-acting antiviral agents (DAAs) may be enrolled if they can produce documentation that they received only placebo.
- •Current enrollment in another interventional clinical study or receipt of any investigational product within 6 weeks prior to study drug administration.
研究组 & 干预措施
3-DAA + RBV 600 mg
3-DAA (ombitasvir/paritaprevir/ritonavir [25 mg/150 mg/100 mg once daily] and dasabuvir [250 mg twice daily]) plus RBV (ribavirin [600 mg once daily]) for 12 weeks.
干预措施: ombitasvir/paritaprevir/ritonavir and dasabuvir (Drug)
3-DAA + RBV 600 mg
3-DAA (ombitasvir/paritaprevir/ritonavir [25 mg/150 mg/100 mg once daily] and dasabuvir [250 mg twice daily]) plus RBV (ribavirin [600 mg once daily]) for 12 weeks.
干预措施: ribavirin (Drug)
结局指标
主要结局
Mean Change in Hemoglobin Values From Baseline to End of Treatment
时间窗: Baseline (Day 1) to Weeks 2, 4, 8, and 12, and the Final Treatment Visit (up to 12 weeks)
The mean change in hemoglobin (g/L) from baseline to each study visit and to the final treatment visit (up to 12 weeks) is provided.
Percentage of Participants With Sustained Virologic Response 12 Weeks Post-treatment (SVR12)
时间窗: 12 weeks after the last actual dose of 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 study drug. The primary efficacy endpoint was noninferiority of the percentage of participants who achieved SVR12 in participants in the treatment arm 3-DAA + RBV 600 mg) for 12 weeks compared with the historical control rate for subjects treated with 3-DAA + weight-based RBV for 12 weeks.
Percentage of Participants With Hemoglobin < 10 g/dL During Treatment
时间窗: up to 12 weeks
The percentage of participants with hemoglobin \<10 g/dL during treatment is provided.
次要结局
- Percentage of Participants With On-treatment Virologic Failure(Up to 12 weeks)
- Percentage of Participants With Post-treatment Relapse(From the end of treatment through 12 weeks after the last dose of study drug)