Triple-Therapy With PegInterferon α-2b + Ribavirin + Boceprevir in Patients With HCV Genotype 3 Who Previously Failed Treatment With PegInterferon α + Ribavirin
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 11
- 试验地点
- 1
- 主要终点
- Sustained Virologic Response (SVR) at 24 Weeks Post Treatment
研究概览
简要总结
The purpose of this study is to test the potential antiviral efficacy of triple-combination therapy with Peginterferon α-2b + ribavirin + boceprevir (PRB) in patients with HCV genotype 3 who previously failed Peginterferon α + ribavirin (non-responders or relapsers).
详细描述
i) Obtain preliminary information on the association between important baseline and on-treatment factors and SVR in this patient population. Variables to be examined may include gender, age, advanced fibrosis or cirrhosis (F3 or F4 estimated by Fibroscan), baseline viral load, RVR, wk 8 viral load, end-of-treatment viral response.
ii) Evaluate adverse events. iii) Evaluate viral resistance.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects will be eligible for the study if they meet the following inclusion criteria:
- •18 years of age or older
- •Infected with HCV genotype 3 (mixed genotypes are NOT permitted)
- •Have received at least 12 weeks of previous treatment with peginterferon-α + ribavirin
- •Detectable serum HCV-RNA
- •No significant co-morbid conditions
- •Liver biopsy is not necessary
- •Cirrhotic patients will be eligible to participate if Child-Pugh class A (maximum 15% of subjects)
排除标准
- •Subjects will be excluded from participation in this study if the following conditions are present:
- •Significant comorbidities: uncontrolled psychiatric conditions including severe depression, cardiovascular, respiratory, renal or metabolic conditions, active carcinoma.
- •Active substance abuse within the past 12 months
- •Co-infection with hepatitis B or HIV
- •Decompensated cirrhosis (Child-Pugh class B or C)
- •Significant cytopenia - any of the following: platelets <80 x 109/L, neutropenia <1.2 x 103/L, Hb <120 g/l for men or 110 g/l for women
- •Lack of informed consent
- •Previous null-responders (<2 log10 decrease at week 12 with previous PR therapy)
研究组 & 干预措施
Boceprevir
干预措施: Boceprevir (Drug)
结局指标
主要结局
Sustained Virologic Response (SVR) at 24 Weeks Post Treatment
时间窗: 24 weeks after treatment
Sustained Virologic Response (SVR) is evaluated 24 weeks after end of treatment and defined as undetectable plasma HCV-RNA at follow up week 24. HCV RNA is measured using Cobas TaqMan.Of the 6 subjects who completed the treatment, 3 obtained SVR at 24 weeks post treatment.
次要结局
未报告次要终点
研究者
Sam Lee
Hepatologist
University of Calgary