Back to results

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

Primary Purpose

Peripheral Arterial Occlusive Disease

Status

Completed

Phase

Phase 1

Locations

International

Study Type

Interventional

Intervention

XRP0038 (NV1FGF)

About this trial

This is an interventional treatment trial for Peripheral Arterial Occlusive Disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

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

pain assessment (self-administered visual analog scale)

Full Information

NCT ID

NCT01157156

First Posted

July 2, 2010

Last Updated

July 2, 2010

Sponsor

Sanofi

1. Study Identification

Unique Protocol Identification Number

NCT01157156

Brief Title

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

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 Type

Interventional

2. Study Status

Record Verification Date

July 2010

Overall Recruitment Status

Completed

Study Start Date

June 1999 (undefined)

Primary Completion Date

September 2001 (Actual)

Study Completion Date

September 2001 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Sanofi

4. Oversight

Data Monitoring Committee

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Peripheral Arterial Occlusive Disease

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

51 (Actual)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

XRP0038 (NV1FGF)

Intervention Description

Pharmaceutical form:solution Route of administration: intramuscular

Primary Outcome Measure Information:

Title

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

Time Frame

12 weeks

Secondary Outcome Measure Information:

Title

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

Time Frame

12 weeks

Title

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

Time Frame

12 weeks

Title

pain assessment (self-administered visual analog scale)

Time Frame

12 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

International Clinical Development Study Director

Organizational Affiliation

Sanofi

Official's Role

Study Director

Facility Information:

City

Minneapolis

State/Province

Minnesota

Country

United States

City

Tempere

Country

Finland

12. IPD Sharing Statement

Citations:

PubMed Identifier

21716303

Citation

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.

Results Reference

derived

Learn more about this trial

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

We'll reach out to this number within 24 hrs