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

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT01157156
• Date of registration: 02/07/2010
• Prospective Registration: No
• Primary sponsor: Sanofi
• Public title: Safety and Tolerability of NV1FGF in Patients With Severe Peripheral Artery Occlusive Disease
• Scientific 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
• Date of first enrolment: June 1999
• Target sample size: 51
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT01157156
• Study type: Interventional
• Study design: Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
• Phase: Phase 1

Countries of recruitment

Finland, United States

Contacts

• Name: International Clinical Development Study Director
• Affiliation: Sanofi

Key inclusion & exclusion criteria

Inclusion criteria:

- Severe PAOD defined as Rutherford's Grade II, category 4 or Grade III, category 5 and
6

- Pain at rest for at least 2 weeks duration and/or trophic lesions for at least the
previous 14 days with no signs of healing (no reduction in ulcer size or depth)

- Objective evidence of peripheral vascular disease (resting Ankle Brachial Index < 0.4
and/or resting Toe Brachial Index < 0.3 and/or metatarsal Peripheral Vascular
Resistance flat or barely pulsatile in the diseased limb on 2 consecutive
examinations performed at least 2 weeks apart)

- Angiographic demonstration of total occlusion of the affected limb of one or more of
the iliac, superficial femoral, popliteal and/or one or more infrapopliteal arteries

- Poor candidate for surgical intervention or revascularization procedures (no tibial
artery incontinuity as defined from mid-leg distance from the foot and no autologous
tissue available)

Exclusion criteria :

- Previous or current history of malignant disease. Patients who had successful tumor
resection more than 10 years prior to inclusion into the study and had no recurrence
and patients who had curatively resected basal/squamous cancer of the skin were
allowed for inclusion

- Abnormal chest X-ray with suspected malignant tumor presence

- Positive stool hemoccult (expect if due to hemorrhoids)

- Positive Prostate Specific Antigen for men with suspected malignant tumor presence

- Abnormal mammography for women with suspected malignant tumor presence

- Papanicolaou smear (for women) of Class IV or Class V characterization

- Proliferative retinopathy

The above information is not intended to contain all considerations relevant to a
patient's potential participation in a clinical trial.



Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Peripheral Arterial Occlusive Disease

Intervention(s)

Drug: XRP0038 (NV1FGF)

Primary Outcome(s)

Safety assessment (adverse events, physical examination,vital signs,ECG, laboratory tests...) [Time Frame: 12 weeks]

Secondary Outcome(s)

pain assessment (self-administered visual analog scale) [Time Frame: 12 weeks]

hemodynamic parameters (TcPO2, Ankle Brachial Index, Toe Brachial Index, pulse volume recording) and angiography [Time Frame: 12 weeks]

ulcers healing assessment (length, width, type, depth) [Time Frame: 12 weeks]

Secondary ID(s)

PM101

TED10106

Source(s) of Monetary Support

Please refer to primary and secondary sponsors