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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01157156
Recruitment Status : Completed
First Posted : July 5, 2010
Last Update Posted : July 5, 2010
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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.

Condition or disease Intervention/treatment Phase
Peripheral Arterial Occlusive Disease Drug: XRP0038 (NV1FGF) Phase 1

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

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 51 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : June 1999
Actual Primary Completion Date : September 2001
Actual Study Completion Date : September 2001

Intervention Details:
  • Drug: XRP0038 (NV1FGF)

    Pharmaceutical form:solution

    Route of administration: intramuscular

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

Secondary Outcome Measures :
  1. hemodynamic parameters (TcPO2, Ankle Brachial Index, Toe Brachial Index, pulse volume recording) and angiography [ Time Frame: 12 weeks ]
  2. ulcers healing assessment (length, width, type, depth) [ Time Frame: 12 weeks ]
  3. pain assessment (self-administered visual analog scale) [ Time Frame: 12 weeks ]

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01157156

United States, Minnesota
Minneapolis, Minnesota, United States
Tempere, Finland
Sponsors and Collaborators
Study Director: International Clinical Development Study Director Sanofi

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: International Clinical Development Study Director, sanofi-aventis Identifier: NCT01157156     History of Changes
Other Study ID Numbers: TED10106
PM101 ( Other Identifier: Gencell )
First Posted: July 5, 2010    Key Record Dates
Last Update Posted: July 5, 2010
Last Verified: July 2010

Additional relevant MeSH terms:
Arterial Occlusive Diseases
Peripheral Arterial Disease
Vascular Diseases
Cardiovascular Diseases
Peripheral Vascular Diseases