A Phase IV, Multisite Study of the Treatment of Chronic Hepatitis C Virus Infection Genotype 1 in a Real World Large Health Maintenance Organization: An Evaluation of Real World Sustained Virological Response and Patient Reported Outcomes
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Sustained Virological Response (SVR) at Week 12
研究概览
简要总结
This is a Phase IV, open-label, multi-center study to evaluate the real world sustained virological response rate, subject adherence, and subject reported outcomes during and after treatment of non-cirrhotic genotype 1 chronic hepatitis C subjects aged 18 years and older, with VIEKIRA PAK (ombitasvir, paritaprevir/r, dasabuvir), with or without RBV (ribavirin).
详细描述
This is a Phase IV, open-label, multi-center study to evaluate the real world sustained virological response rate, subject adherence, and subject reported outcomes during and after treatment of non-cirrhotic genotype 1 chronic hepatitis C subjects aged 18 years and older, with the AbbVie 3 direct-acting antiviral (3-DAA) regimen of VIEKIRA PAK (ombitasvir, paritaprevir/r, dasabuvir), with or without RBV (ribavirin).
Subjects may be treatment-naïve or treatment experienced with pegylated-interferon based regimens excluding regimens with direct-acting antiviral agents. The study will be conducted at multiple Kaiser Permanente Southern California Medical Centers.
The primary objective of this open label study is to evaluate the rate of sustained virological response rate 12 weeks after completion of treatment (SVR12) with VIEKIRA PAK, with or without ribavirin in a large real world setting.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Genotype 1a
Study participants with chronic Hepatitis C Genotype 1A receiving VIEKIRA PAK (two 12.5/75/50 mg ombitasvir, paritaprevir, ritonavir tablets, and two 250 mg dasabuvir tablets) and RBV (ribavirin tablets) for 12 weeks.
干预措施: ombitasvir, paritaprevir/r, dasabuvir + ribavirin (Drug)
Genotype 1b
Study participants with chronic Hepatitis C Genotype 1B receiving VIEKIRA PAK (two 12.5/75/50 mg ombitasvir, paritaprevir, ritonavir tablets, and two 250 mg dasabuvir tablets) for 12 weeks.
干预措施: ombitasvir, paritaprevir/r, dasabuvir (Drug)
结局指标
主要结局
Sustained Virological Response (SVR) at Week 12
时间窗: 12 weeks
Percentage of study participants achieving sustained virological response (SVR) at Week 12 per protocol among study participants who completed 12-week course of treatment.
次要结局
- Sustained Virological Response (SVR) at Week 4(4 weeks)