Quality of Life Measurement Using Wrist Actigraphy in HCV Genotype 1 Infected, Treatment naïve Patients Suffering From Fatigue and Receiving Ombitasvir, Paritaprevir, and Ritonavir Tablets and Dasabuvir Tablets (Viekirax®/Exviera®; 3D Regimen): The HEMATITE Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 41
- 试验地点
- 5
- 主要终点
- Change From Baseline at Day 168 in Mean Daytime Physical Activity
研究概览
简要总结
This is an observational, prospective, open-label, single-arm, multicenter, real-life study designed to observe the impact of paritaprevir/ritonavir/ombitasvir with dasabuvir regimen (Viekirax®/Exviera®, 3D regimen) on total daytime physical activity and fatigue in participants with HCV GT1.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Treatment-naïve participants
- •Mono-infected participants with chronic HCV GT1
- •Non-cirrhotic participants
- •Participants with debilitating fatigue (Fatigue Severity Scale [FSS] greater than or equal to 4)
排除标准
- •Participants with sources of fatigue other than HCV (especially, severe depression, cancer and hormonal disorders causing clinically significant fatigue)
- •Participants with conditions that do not allow to adhere to protocol and use of the device at investigator's discretion
- •Participants who are wheelchair dependent
结局指标
主要结局
Change From Baseline at Day 168 in Mean Daytime Physical Activity
时间窗: Baseline, Day 168
Mean daytime physical activity for 2 eligible weeks (10 working days) prior to the assessment day was derived from a wrist-worn activity tracker (ActiGraph GT9X Link), which measures activity via a 3-axis algorithm. For total daytime physical activity, the measured counts of the activity tracker data minus total sleep counts were used as day-counts. Higher day-counts signify more activity.
次要结局
- Correlation Coefficients of FSS and Mean Daytime Physical Activity: mITT Population(Baseline, Days 28, 84, 168)
- Change From Baseline Over Time in Mean Daytime Physical Activity(Baseline, Days 28, 84, 168)
- Change From Baseline Over Time in Fatigue Severity Scale (FSS) Score(Baseline, Days 28, 84, 168)
- Correlation Coefficients of FSS and Mean Daytime Physical Activity: sdITT Population(Baseline, Days 28, 84, 168)
- Change From Baseline Over Time in Sleep Efficiency(Baseline, Days 28, 84, 168)
- Correlation Coefficients of Change From Baseline Over Time in FSS and Mean Daytime Physical Activity: sdITT Population(Baseline, Days 28, 84, 168)
- Correlation Coefficients of Change From Baseline Over Time in FSS and Mean Daytime Physical Activity: mITT Population(Baseline, Days 28, 84, 168)
- Percentage of Participants With Sustained Virologic Response 12 Weeks (SVR12) Post-Treatment(Day 168 (or 12 weeks after the last dose of study drug))