NCT00566657|CompletedPhase 3DMC

Efficacy and Safety of XRP0038/NV1FGF in Critical Limb Ischemia Patients With Skin Lesions

TAMARIS

A Randomized Double-Blind Placebo-Controlled Parallel Group Study of the Efficacy and Safety of XRP0038/NV1FGF on Amputation or Any Death in Critical Limb Ischemia Patients With Skin Lesions

Sanofi ClinicalTrials.gov

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2 other identifiers

EFC61452006-006277-24

Study Type

interventional

Target

525

Locations

29 countries

Sites

Timeline

RegisteredDec 2007

StartedNov 2007

CompletionAug 2012

Brief Summary

Primary objective is to demonstrate the superiority of riferminogene pecaplasmid (XRP0038/NV1FGF) over placebo in the prevention of major amputation above the ankle of the treated leg or of death from any cause, whichever comes first, in critical limb ischemia (CLI) patients with skin lesions. Secondary objectives are to evaluate:

The efficacy of riferminogene pecaplasmid versus placebo for delaying the time to major amputation;
The efficacy of riferminogene pecaplasmid versus placebo for delaying the time to death;
The safety of riferminogene pecaplasmid in the study population.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

525

participants targeted

Target at P75+ for phase_3

Timeline

Completed

Started Nov 2007

Longer than P75 for phase_3

Geographic Reach

29 countries

29 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

4.8 years study duration

Study Start

First participant enrolled

November 1, 2007

Completed

29 days until next milestone

First Submitted

Initial submission to the registry

November 30, 2007

Completed

3 days until next milestone

First Posted

Study publicly available on registry

December 3, 2007

Completed

2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2010

Completed

2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2012

Completed

Last Updated

May 2, 2016

Status Verified

March 1, 2016

Enrollment Period

2.8 years

First QC Date

November 30, 2007

Last Update Submit

March 30, 2016

Conditions

Peripheral Vascular Diseases

Keywords

Critical Limb IschemiaPeripheral Artery DiseasePlasmid based gene therapy

Outcome Measures

Primary Outcomes (1)

Time to major amputation of the treated leg or death from any cause, whichever comes first
From randomization up to 12 months

Secondary Outcomes (3)

Time to first major amputation of the treated leg
From randomization up to 12 months
Time to death from any cause
From randomization up to 12 months
Number of participants with adverse events as a measure of safety
From 1st treatment administration up to death, or the earliest of Day 360 or last contact/assessment

Study Arms (2)

Riferminogene pecaplasmid

EXPERIMENTAL

4 administrations of riferminogene pecaplasmid 4 mg at 2-week intervals

Biological: riferminogene pecaplasmid

Placebo

PLACEBO COMPARATOR

4 administrations of placebo (for riferminogene pecaplasmid) at 2-week intervals

Biological: Placebo (for riferminogene pecaplasmid)

Interventions

riferminogene pecaplasmidBIOLOGICAL

Formulation: 5 ml glass vials containing 2,5 ml riferminogene pecaplasmid Route: intramuscular (IM) injection of 2.5 mL in the ischemic leg to be treated

Also known as: NV1FGF, XRP0038

Riferminogene pecaplasmid

Placebo (for riferminogene pecaplasmid)BIOLOGICAL

Formulation: 5 ml glass vials containing 2,5 ml placebo Route: IM injection of 2.5 mL in the ischemic leg to be treated

Placebo

Eligibility Criteria

Age50 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Having peripheral artery disease at the stage of Critical Limb Ischemia (CLI) with skin lesions (either ulcer(s) or gangrene);
With objective evidence of CLI such as ankle systolic pressure \<70 mmHg and/or toe systolic pressure \<50 mmHg or transcutaneous oxygen pressure (TcPO2) \<30 mmHg;
Unsuitable for standard revascularization of his/her peripheral arterial disease;
Having a negative screening for cancer.

You may not qualify if:

Previous major amputation on the leg to be treated or planned major amputation within the first month following randomization;
Known Buerger's disease;
Successful lower extremity revascularization procedure within 3 months prior randomization;
Uncontrolled blood pressure defined as systolic blood pressure (SBP) ≥180 mmHg or diastolic blood pressure (DBP) ≥110 mmHg despite adequate antihypertensive treatment;
Acute cardiovascular events within 3 months prior to randomization;
Active proliferative retinopathy and severe macular oedema;
Previous or current history of malignant disease within the past 5 years;
Previous treatment with systemic angiogenic factors or with stem cells therapy;
Pregnant or breast-feeding woman or woman of childbearing potential not protected by an effective contraceptive method of birth control. Man not following effective contraceptive method with his partner of childbearing potential during the course of the study.
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Contact the study team to confirm eligibility.