The Role of Combined Ribavirin and Sofosbuvir/Velpatasvir/Voxilaprevir in Treatment of Chronic Hepatitis C Non-responders; A Randomized Controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 281
- 试验地点
- 1
- 主要终点
- Achievement of sustained virological response (SVR)
研究概览
简要总结
This study aims to assess the role of ribavirin as an adjuvant to sofosbuvir/velpatasvir/voxilaprevir combination in retreatment of chronic hepatitis C with previous treatment failure.
研究设计
- 研究类型
- Interventional
- 分配方式
- 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
- •Adult (≥ 18 years) patients with chronic hepatitis C and detectable HCV RNA by Polymerase Chain Reaction (PCR) after completion of previous direct-acting antiviral regimen, and eligible for antiviral treatment.
排除标准
- •Patients with decompensated cirrhosis (Child-Pugh score B and C).
- •Patients with platelet count less than 50000/ mm³.
- •Patients with HCC or extrahepatic malignancy.
- •Pregnancy or inability to use an effective contraceptive method.
研究组 & 干预措施
Group A: SOF/VEL/VOX with RBV
Drug: Sofosbuvir/Velpatasvir/Voxilaprevir 400/100/100 mg tablets (single pill combination administered orally once daily) plus Ribavirin (weight-based dose 1000 or 1200 mg daily according to patient body weight: < or > 60 kg).
Another name: Vosevi, RBV
干预措施: Sofosbuvir / Velpatasvir / Voxilaprevir Oral Tablet [Vosevi] plus Ribavirin (Drug)
Group B: SOF/VEL/VOX
Drug: Sofosbuvir/Velpatasvir/Voxilaprevir 400/100/100 mg tablets (single pill combination administered orally once daily).
Another name: Vosevi
干预措施: Sofosbuvir / Velpatasvir / Voxilaprevir Oral Tablet [Vosevi] (Drug)
结局指标
主要结局
Achievement of sustained virological response (SVR)
时间窗: 12 weeks post treatment
Percentage of patients with Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12) SVR12 is defined as HCV RNA \< the lower limit of quantitation 12 weeks following the last dose of study drug.
次要结局
- Tolerability(During 12 weeks of treatment)
研究者
Mohammed Emadeldeen
Hepato-gastroenterology specialist
Helwan University