Back to results

Efficacy and Safety Study of NV1FGF in Patients With Severe Peripheral Artery Occlusive Disease. (TALISMAN202)

Primary Purpose

Severe Peripheral Artery Occlusive Disease

Status

Completed

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

XRP0038 (NV1FGF)

About this trial

This is an interventional treatment trial for Severe Peripheral Artery Occlusive Disease focused on measuring NV1FGF, PAOD, CLI

Eligibility Criteria

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

Inclusion Criteria:

Informed consent was to be signed before proceeding with any study procedure.
Patients with severe PAD.
Trophic lesions with no signs of healing (no reduction in ulcer size or depth) for at least 2 weeks prior to first study treatment administration (Day 1).
Patients with objective evidence of peripheral vascular disease in the diseased limb on 2 consecutive examinations performed at least 1 week apart.
Demonstration or documentation of total occlusion of the affected limb of one or more of the iliac, superficial femoral, popliteal and/or one or more infrapopliteal arteries as assessed by angiography or magnetic resonance angiography (MRA)
Transcutaneous oxygen pressure (TcPO2): mean resting supine TcPO2 of the foot of ≤40 mmHg based on 2 separate measures performed at least 1 week apart
Poor/not candidates for revascularization

Exclusion criteria

Previous or current history of malignant disease.
Positive cancer screening (liver, prostate, colon, cervix, breast, lung)
Successful lower extremity surgery (bypass/angioplasty of the leg to be treated) within 3 months prior to the first administration of study treatment [Day 1]).
Patients planned to undergo amputation of target limb within 1 month following the first administration of study treatment.
Patients with a history of severe renal failure.
Creatinine >2.0 mg/dL (176 µmol/L) or estimated creatinine clearance <30 mL.
Serious concomitant medical conditions not adequately controlled (other than severe PAD),
Buerger's disease.
Patients in dialysis.
Active proliferative retinopathy
Patients who had a stroke or neurologic deficit presumed to be due to stroke within 3 months prior to the first administration of study treatment.
Previous treatment with any angiogenic growth factor.
Positive serology for HIV 1 or 2.
Participation in clinical trials of non-approved experimental agents within 4 weeks before study entry.

Sites / Locations

Sanofi-Aventis Administrative Office

Outcomes

Primary Outcome Measures

evaluate the efficacy and the safety of NV1FGF compared to placebo in patients with severe PAOD.

Secondary Outcome Measures

evaluate the biodistribution of NV1FGF and to measure serum levels of antibodies against FGF-1

Full Information

NCT ID

NCT00798005

First Posted

November 24, 2008

Last Updated

June 7, 2017

Sponsor

Sanofi

1. Study Identification

Unique Protocol Identification Number

NCT00798005

Brief Title

Efficacy and Safety Study of NV1FGF in Patients With Severe Peripheral Artery Occlusive Disease.

Acronym

TALISMAN202

Official Title

A Phase II, Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Efficacy and Safety Study of Different Doses and Schedules of Administration of NV1FGF in Patients With Severe Peripheral Artery Occlusive Disease.

Study Type

Interventional

2. Study Status

Record Verification Date

June 2017

Overall Recruitment Status

Completed

Study Start Date

June 2002 (undefined)

Primary Completion Date

July 2005 (Actual)

Study Completion Date

July 2005 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Sanofi

4. Oversight

5. Study Description

Brief Summary

Peripheral Arterial Occlusive Disease (PAOD) is a condition caused by ischemia in the legs due to atherosclerotic disease affecting the larger arteries of the legs. Chronic PAOD can be regarded as a marker of generalized atherosclerosis. PAOD threatens the survival of an extremity and often causes lifelong disablement from a painful leg. The clinical consequences of PAOD include pain on walking (claudication), pain at rest and loss of tissue integrity in the distal limbs.A variety of medical therapies have been investigated for patients with PAOD. There is currently no evidence to suggest that any medical therapy is effective for patients with rest pain and/or ischemic ulcers. Also, the use of intramuscular angiogenic VEGF-A gene transfer has recently demonstrated a improvement in clinical and hemodynamic status in patients with severe PAOD

6. Conditions and Keywords

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

Severe Peripheral Artery Occlusive Disease

Keywords

NV1FGF, PAOD, CLI

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

71 (Actual)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

XRP0038 (NV1FGF)

Primary Outcome Measure Information:

Title

evaluate the efficacy and the safety of NV1FGF compared to placebo in patients with severe PAOD.

Secondary Outcome Measure Information:

Title

evaluate the biodistribution of NV1FGF and to measure serum levels of antibodies against FGF-1

10. Eligibility

Sex

All

Minimum Age & Unit of Time

45 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Informed consent was to be signed before proceeding with any study procedure. Patients with severe PAD. Trophic lesions with no signs of healing (no reduction in ulcer size or depth) for at least 2 weeks prior to first study treatment administration (Day 1). Patients with objective evidence of peripheral vascular disease in the diseased limb on 2 consecutive examinations performed at least 1 week apart. Demonstration or documentation of total occlusion of the affected limb of one or more of the iliac, superficial femoral, popliteal and/or one or more infrapopliteal arteries as assessed by angiography or magnetic resonance angiography (MRA) Transcutaneous oxygen pressure (TcPO2): mean resting supine TcPO2 of the foot of ≤40 mmHg based on 2 separate measures performed at least 1 week apart Poor/not candidates for revascularization Exclusion criteria Previous or current history of malignant disease. Positive cancer screening (liver, prostate, colon, cervix, breast, lung) Successful lower extremity surgery (bypass/angioplasty of the leg to be treated) within 3 months prior to the first administration of study treatment [Day 1]). Patients planned to undergo amputation of target limb within 1 month following the first administration of study treatment. Patients with a history of severe renal failure. Creatinine >2.0 mg/dL (176 µmol/L) or estimated creatinine clearance <30 mL. Serious concomitant medical conditions not adequately controlled (other than severe PAD), Buerger's disease. Patients in dialysis. Active proliferative retinopathy Patients who had a stroke or neurologic deficit presumed to be due to stroke within 3 months prior to the first administration of study treatment. Previous treatment with any angiogenic growth factor. Positive serology for HIV 1 or 2. Participation in clinical trials of non-approved experimental agents within 4 weeks before study entry.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

ICD CSD

Organizational Affiliation

Sanofi

Official's Role

Study Director

Facility Information:

Facility Name

Sanofi-Aventis Administrative Office

City

Bridgewater

State/Province

New Jersey

Country

United States

12. IPD Sharing Statement

Citations:

Citation

Henry TD, Mendelsohn F, Comerota A, Pham E, Grek V, Coleman M, Meyer F, Annex B Dose and regimen effects of intramuscular NV1FGF in patients with critical limb ischemia: A randomized, double-blind, placebo controlled study. Eur H J 2006, 27 Suppl 1 Abs P1497

Results Reference

result

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

Links:

URL

http://www.sanofi-aventis.com

Description

Related Info

Learn more about this trial

Efficacy and Safety Study of NV1FGF in Patients With Severe Peripheral Artery Occlusive Disease.

We'll reach out to this number within 24 hrs