Interferon-free Antiviral Treatment of HCV-Positive Genotype 1b Related Indolent Non-Hodgkin Lymphomas Patients Using Daclatasvir and Asunaprevir: A Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 主要终点
- HCV clearance and complete regression of NHL by ASV+ DCV
研究概览
简要总结
Interferon-free Antiviral Treatment of HCV-Positive Genotype 1b Related Indolent non-Hodgkin Lymphomas Patients Using Daclatasvir and Asunaprevir: A Pilot Study
详细描述
Prospectively collect cases with NHL (n=10), having HCV genotype 1b related NHL, who will be treated with ASV (200 mg twice daily) + DCV(60 mg once daily) for 24 weeks The patients will be observed and followed to determine whether there is regression of NHL after antiviral treatment. Conventional chemotherapy should be initiated shortly in cases without regression.
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men and women
- •18 to 70 years of age
- •Who had chronic HCV genotype 1b infection
- •An HCV RNA level of 105 IU per milliliter or higher
- •Being diagnosed to be low grade B cell non-Hodgkin lymphoma
排除标准
- •Patients with hepatitis B virus infection,
- •Other liver diseases
- •HIV infection,
- •Pre-existing HCV variants in the NS5A domain included Q30R, L31 M/V, and Y93C/N
- •Evidence of cirrhosis, as documented by means of either liver biopsy or assessment of imaging results.
研究组 & 干预措施
Daclatasvir + Asunaprevir
Prospectively collect cases with NHL (n=10), having HCV genotype 1b related NHL, who will be treated with ASV (200 mg twice daily) + DCV(60 mg once daily) for 24 weeks .
干预措施: Daclatasvir+ Asunaprevir (Drug)
结局指标
主要结局
HCV clearance and complete regression of NHL by ASV+ DCV
时间窗: 2years
patients who had undetectable HCV RNA levels at or after week 4. Viral relapse was defined as confirmed detectable HCV RNA levels during the post-treatment follow-up period in patients who had had undetectable HCV RNA levels at the end of treatment
次要结局
未报告次要终点