Ribavirin Bioavailability After Telaprevir Exposure in Hepatitis C Patients Treated With PEGylated -Interferon/Ribavirin/Telaprevir Triple Therapy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 37
- 试验地点
- 1
- 主要终点
- Change in ribavirin plasma trough concentration between baseline and week 4 of triple therapy
研究概览
简要总结
Anemia is more frequent in patients receiving telaprevir with pegylated-interferon/ribavirin than in those receiving pegylated-interferon/ribavirin alone. The objective was to measure the impact of telaprevir on ribavirin bioavailability and to assess the concomitant renal function.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
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
- •Patients with hepatitis C virus infection
- •Previous non-response to pegylated-interferon/ribavirin therapy
- •Re-treatment with pegylated-interferon/ribavirin and telaprevir
排除标准
- •Decompensated liver cirrhosis
研究组 & 干预措施
Hepatitis C patients
Hepatitis C virus (HCV) infected patients with a previous non-response to pegylated-interferon/ribavirin therapy and re-treated with pegylated-interferon/ribavirin and telaprevir
干预措施: Triple therapy (Drug)
结局指标
主要结局
Change in ribavirin plasma trough concentration between baseline and week 4 of triple therapy
时间窗: before telaprevir initiation during the previous course of PEG (pegylated)-IFN (interferon)/ribavirin combination therapy (T-1), and during the early phase (week 4 ± 2 weeks) of therapy
Plasma ribavirin trough concentrations were measured using a validated high-performance liquid chromatography-diode array detector method, a highly specific, sensible, and precise method of quantification
次要结局
- Ribavirin plasma trough concentration at week 8 of therapy(at the later phase of therapy (Week 8 ± 2 weeks))
- Change in renal function between baseline and week 4 of triple therapy(Before telaprevir initiation (T-1), and during the early phase (week 4 ± 2 weeks) of therapy)
- Ribavirin plasma trough concentration after telaprevir withdrawal(after telaprevir cessation (at least 4 weeks after telaprevir withdrawal (Week 16)))
- Renal function at week 8 of therapy(at the later phase of therapy (Week 8 ± 2 weeks))
- Renal function after telaprevir withdrawal(after telaprevir cessation (at least 4 weeks after telaprevir withdrawal (Week 16)))