NCT00367887已完成2 期
A Phase 2, Randomized, Open-Label Study Of The Safety, Antiviral Activity, And Pharmacokinetics Of HCV-796 Administered In Combination With Peginterferon Alfa 2B (Peg-Intron) Plus Ribavirin (Rebetol) Versus Peg-Intron Plus Rebetol In Subjects With Hepatitis C Virus Genotype 1 Infection
Wyeth is now a wholly owned subsidiary of Pfizer1 个研究点 分布在 1 个国家目标入组 246 人开始时间: 2006年10月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 246
- 试验地点
- 1
- 主要终点
- Hepatitis C Virus (HCV) RNA concentrations in the blood.
研究概览
简要总结
This is a phase 2, randomized, open-label study comparing the safety, antiviral activity, and pharmacokinetics of HCV-796 administered in combination with peginterferon alfa 2B (Peg-Intron) plus concomitant Rebetol vs. Peg-Intron plus Rebetol in Hepatitis C Virus (HCV) genotype
1-infected subjects who are either naive to treatment or who have previously failed treatment (non-responders).
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Infection with HCV genotype
- •HCV- infected subjects naive to treatment.
- •HCV-infected non-responder subjects.
排除标准
- •Women who are pregnant or breastfeeding.
- •ALT >/ or = 5X the upper limit of normal.
- •AST >/ or = 5X the upper limit of normal.
研究组 & 干预措施
1
Active Comparator
干预措施: Peg-Intron (Drug)
1
Active Comparator
干预措施: REBETOL (Drug)
2
Active Comparator
干预措施: HCV 796 (Drug)
2
Active Comparator
干预措施: Peg-Intron (Drug)
2
Active Comparator
干预措施: REBETOL (Drug)
3
Active Comparator
干预措施: HCV 796 (Drug)
3
Active Comparator
干预措施: Peg-Intron (Drug)
3
Active Comparator
干预措施: REBETOL (Drug)
结局指标
主要结局
Hepatitis C Virus (HCV) RNA concentrations in the blood.
时间窗: 72 weeks
次要结局
未报告次要终点
研究者
研究点 (1)
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