NCT01157156已完成1 期
A Phase I, Multi-Center, Open Label, Safety and Tolerability Study of Single and Repeated Administrations of Escalating Dose(s) of NV1FGF Administered by Intra-Muscular Injection in Patients With Severe Peripheral Artery Occlusive Disease
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Sanofi
- 入组人数
- 51
- 试验地点
- 2
- 主要终点
- Safety assessment (adverse events, physical examination,vital signs,ECG, laboratory tests...)
研究概览
简要总结
The primary objective is to evaluate safety and tolerability of single and repeated administrations of escalating doses of NV1FGF administered intramuscularly in patients with severe Peripheral Artery Occlusive Disease (PAOD), (Rutherford's Grade II, category 4 or Grade III, category 5 and 6).
Secondary objectives are:
- To determine the biological activity of NV1FGF on collateral artery development.
- To evaluate the activity of NV1FGF on hemodynamic and clinical parameters.
详细描述
Screening period of 30 days before dosing. Patients receive a single administration or repeated (2) administrations (with a 2-week interval) of NV1FGF. Patients are then followed for a period of 6 months
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 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
- 未提供
排除标准
- 未提供
结局指标
主要结局
Safety assessment (adverse events, physical examination,vital signs,ECG, laboratory tests...)
时间窗: 12 weeks
次要结局
- ulcers healing assessment (length, width, type, depth)(12 weeks)
- pain assessment (self-administered visual analog scale)(12 weeks)
- hemodynamic parameters (TcPO2, Ankle Brachial Index, Toe Brachial Index, pulse volume recording) and angiography(12 weeks)
研究者
研究点 (2)
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