Clinical Trials Logo
  1. Home
  2. Other
  3. NCT01157156

Safety and Tolerability of NV1FGF in Patients With Severe Peripheral Artery Occlusive Disease

Peripheral Arterial Occlusive Disease Clinical Trial

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

Clinical Trial Summary

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.

Clinical Trial Description

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 ;

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01157156
Study type Interventional
Source Sanofi
Contact
Status Completed
Phase Phase 1
Start date June 1999
Completion date September 2001
View Details
See also
  Status Clinical Trial Phase
Recruiting NCT05961943 - RESPONSE-2-PAD to Reduce Sedentary Time in Peripheral Arterial Disease Patients N/A
Completed NCT02900274 - "All Comers" Post Market Clinical Follow-up (PMCF) With Multi-LOC for flOw liMiting Outcomes (LOCOMOTIVE Extended)
Withdrawn NCT01938924 - Surgical Revascularisation and Nerve Stimulation Trial N/A
Completed NCT00740207 - Pilot Study to Compare ISOVUE®-250 and VISIPAQUE™ 270 for Motion Artifact and Pain in Peripheral DSA Phase 4
Active, not recruiting NCT06056193 - The SIR-POBA Bypass Trial N/A
Recruiting NCT06082466 - FRAMED Infrainguinal Venous Bypass Versus Conventional Autologous Bypass Trial N/A
Completed NCT05590182 - CO2-Angiography-Study to Evaluate Diagnostic and Safety to Patients With Peripher Arterial Stenotic or Occlusive Disease. N/A
Recruiting NCT03638115 - The VaSecure BTK Study N/A
Recruiting NCT01774058 - The Arterial Measurement of the Blood Flow Volume After Iloprost Stimulation Phase 2
Active, not recruiting NCT00566436 - Remote Endarterectomy Versus Suprageniculate Femoropopliteal Bypass N/A
Active, not recruiting NCT00863967 - Early Detection of Arteriosclerosis N/A
Recruiting NCT05586022 - Risk Factors for Adverse Outcomes of Endovascular Revascularization in Lower Extremity Arteriosclerosis Occlusion
Completed NCT02929095 - The Effect of Remifentanil-dexmedetomidine Compared With Remifentanil-midazolam on Patient's Satisfaction N/A
Completed NCT02832570 - Sildenafil Efficacy Study on Time Walk From Peripheral Arterial Desease Patients (Stade II) With Arterial Claudication Phase 3
Terminated NCT01341340 - The ABSORB BTK (Below The Knee) Clinical Investigation N/A
Completed NCT02867501 - Venous Distension in Patients With Aneurysmatic Arterial Disease N/A
Active, not recruiting NCT02460042 - Clinical Post Market Clinical Follow-up (PMCF) on Peripheral Arteries Treated With SeQuent® Please Over The Wire (OTW)
Completed NCT01855412 - Observational Study to Evaluate PAD Treatment Clinical and Economic Outcomes
Terminated NCT00717639 - Vasovist Magnetic Resonance Angiography (MRA) in Peripheral Arterial Occlusive Disease Phase 4
Completed NCT00459888 - Cryoplasty CLIMB-registry Phase 4