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

NCT01157156 | Completed Phase 1

• 2 other identifiers: TED10106PM101
• Study Type: interventional
• Target: 51
• Locations: 2 countries
• Sites: 2

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.

Conditions

Peripheral Arterial Occlusive Disease

Outcome Measures

Primary Outcomes (1)

• Safety assessment (adverse events, physical examination,vital signs,ECG, laboratory tests...)

  12 weeks

Secondary Outcomes (3)

• hemodynamic parameters (TcPO2, Ankle Brachial Index, Toe Brachial Index, pulse volume recording) and angiography

  12 weeks

• ulcers healing assessment (length, width, type, depth)

  12 weeks

• pain assessment (self-administered visual analog scale)

  12 weeks

Interventions

XRP0038 (NV1FGF) DRUG

Pharmaceutical form:solution Route of administration: intramuscular

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sanofi: lead

Study Sites (2)

Unknown Facility

Minneapolis, Minnesota, United States

Location

Unknown Facility

Tempere, Finland

Location

Related Publications (1)

• 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.

  PMID: 21716303 DERIVED

MeSH Terms

Conditions

Peripheral Arterial Occlusive Disease 1

Study Officials

• International Clinical Development Study Director

  Sanofi

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: July 2, 2010
• First Posted: July 5, 2010
• Study Start: June 1, 1999
• Primary Completion: September 1, 2001
• Study Completion: September 1, 2001
• Last Updated: July 5, 2010

Record last verified: 2010-07

Locations

US (1); FI (1)