NCT01157871已完成2 期
Double-blind, Randomized, Placebo-controlled, Parallel Group and Dose-finding, Multicentric, Safety and Efficacy Study With Intramuscular Injections of NV1FGF in Subjects With Intermittent Claudication
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
- Sanofi
- 入组人数
- 36
- 主要终点
- Change from baseline in Absolute Claudication Distance (ACD) evaluated by treadmill test at week 13
研究概览
简要总结
The primary objective is to assess safety and efficacy of two different doses of NV1FGF as compared to placebo.
The secondary objective is to assess the pharmacokinetics of NV1FGF and FGF-1 protein.
详细描述
Screening of 1 to 4 weeks before study drug administration; 6 weeks of treatment, followed by 20 weeks of follow-up.
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
- Double
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
placebo
Experimental
4 administrations at 2-week interval of placebo solution
干预措施: placebo (Drug)
NV1FGF 16 mg
Experimental
4 administrations at 2-week interval of 4mg at each administration
干预措施: XRP0038 (NV1FGF) (Drug)
NV1FGF 32 mg
Experimental
4 administrations at 2-week interval of 8mg at each administration
干预措施: XRP0038 (NV1FGF) (Drug)
结局指标
主要结局
Change from baseline in Absolute Claudication Distance (ACD) evaluated by treadmill test at week 13
时间窗: 13 weeks
次要结局
- NV1FGF DNA 69 base pair (bp) in plasma(up to week 27)
- NV1FGF DNA 825 bp in plasma(up to week 27)
- FGF-1 in plasma(up to week 27)
- Anti-FGF1 antibodies in serum(up to week 27)
研究者
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