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

This study has been completed.
Sponsor:
Information provided by:
Sanofi
ClinicalTrials.gov Identifier:
NCT01157156
First received: July 2, 2010
Last updated: NA
Last verified: July 2010
History: No changes posted
  Purpose

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 Intervention Phase
Peripheral Arterial Occlusive Disease
Drug: XRP0038 (NV1FGF)
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: 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

Further study details as provided by Sanofi:

Primary Outcome Measures:
  • Safety assessment (adverse events, physical examination,vital signs,ECG, laboratory tests...) [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • hemodynamic parameters (TcPO2, Ankle Brachial Index, Toe Brachial Index, pulse volume recording) and angiography [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • ulcers healing assessment (length, width, type, depth) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • pain assessment (self-administered visual analog scale) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Enrollment: 51
Study Start Date: June 1999
Study Completion Date: September 2001
Primary Completion Date: September 2001 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: XRP0038 (NV1FGF)

    Pharmaceutical form:solution

    Route of administration: intramuscular

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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01157156

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

No publications provided by Sanofi

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: International Clinical Development Study Director, sanofi-aventis
ClinicalTrials.gov Identifier: NCT01157156     History of Changes
Other Study ID Numbers: TED10106, PM101
Study First Received: July 2, 2010
Last Updated: July 2, 2010
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on August 01, 2014