Safety and Tolerability of NV1FGF in Patients With Severe Peripheral Artery Occlusive Disease
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.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||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|
- Safety assessment (adverse events, physical examination,vital signs,ECG, laboratory tests...) [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
- hemodynamic parameters (TcPO2, Ankle Brachial Index, Toe Brachial Index, pulse volume recording) and angiography [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
- ulcers healing assessment (length, width, type, depth) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
- pain assessment (self-administered visual analog scale) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
|Study Start Date:||June 1999|
|Study Completion Date:||September 2001|
|Primary Completion Date:||September 2001 (Final data collection date for primary outcome measure)|
Drug: XRP0038 (NV1FGF)
Route of administration: intramuscular
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