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

NCT ID: NCT01157156

Last Updated: 2010-07-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 51 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 1999-06-30
• Study Completion Date: 2001-09-30

Brief 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.

Detailed 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

Conditions

Peripheral Arterial Occlusive Disease

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

XRP0038 (NV1FGF)

Pharmaceutical form:solution

Route of administration: intramuscular

Intervention Type: DRUG

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sanofi

INDUSTRY

Sponsor Role: lead

Responsible Party

sanofi-aventis

Principal Investigators

International Clinical Development Study Director

Role: STUDY_DIRECTOR

Sanofi

Locations

Minneapolis, Minnesota, United States

Tempere, , Finland

Countries

United States; Finland

References

Niebuhr A, Henry T, Goldman J, Baumgartner I, van Belle E, Gerss J, Hirsch AT, Nikol S. Long-term safety of intramuscular gene transfer of non-viral FGF1 for peripheral artery disease. Gene Ther. 2012 Mar;19(3):264-70. doi: 10.1038/gt.2011.85. Epub 2011 Jun 30.

Reference Type: DERIVED

PMID: 21716303 (View on PubMed)

Other Identifiers

PM101

Identifier Type: OTHER

Identifier Source: secondary_id

TED10106

Identifier Type: -

Identifier Source: org_study_id