Safety and Tolerability of NV1FGF in Patients With Severe... | NCT01157156

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

NCT01157156

Sponsor

Sanofi

Status

Completed

Last Update Posted

Jul 5, 2010Estimated

Enrollment

51Actual

Phase

Phase 1

Conditions

Peripheral Arterial Occlusive Disease

Interventions

XRP0038 (NV1FGF)

Countries

United States
Finland

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
PM101	Other Identifier	Gencell

Status Module

Record Verification Date

Jul 2010

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 1999

Primary Completion Date

Sep 2001Actual

Completion Date

Sep 2001Actual

First Submitted Date

Jul 2, 2010

First Submission Date that Met QC Criteria

Jul 2, 2010

First Posted Date

Jul 5, 2010Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 2, 2010

Last Update Posted Date

Jul 5, 2010Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

51Actual

Name	Type	Description	Arm Group Labels	Other Names
XRP0038 (NV1FGF)	Drug	Pharmaceutical form:solution Route of administration: intramuscular

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Safety assessment (adverse events, physical examination,vital signs,ECG, laboratory tests...)		12 weeks

Secondary Outcomes

Measure	Description	Time Frame
hemodynamic parameters (TcPO2, Ankle Brachial Index, Toe Brachial Index, pulse volume recording) and angiography		12 weeks
ulcers healing assessment (length, width, type, depth)		12 weeks

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
International Clinical Development Study Director	Sanofi	Study Director

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
21716303	Derived	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.

Facility	Status	City	State	ZIP	Country	Contacts
		Minneapolis	Minnesota		United States