Dose-finding, Safety and Efficacy Study of NV1FGF in Pati... | NCT01157871

Studies
Dose-finding, Safety and Efficacy Study of NV1FGF in Patients With Intermittent Claudication

NCT01157871

Sponsor

Sanofi

Status

Completed

Last Update Posted

Jul 7, 2010Estimated

Enrollment

36Actual

Phase

Phase 2

Conditions

Peripheral Arterial Occlusive Disease

Interventions

XRP0038 (NV1FGF)
placebo

Countries

United States
Belgium
Germany
Switzerland

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
PM211	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 2004

Primary Completion Date

Aug 2005Actual

Completion Date

Aug 2005Actual

First Submitted Date

Jul 6, 2010

First Submission Date that Met QC Criteria

Jul 6, 2010

First Posted Date

Jul 7, 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 6, 2010

Last Update Posted Date

Jul 7, 2010Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

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 assess safety and efficacy of two different doses of NV1FGF as compared to placebo.

The secondary objective is to assess the pharmacokinetics of NV1FGF and FGF-1 protein.

Detailed Description

Screening of 1 to 4 weeks before study drug administration; 6 weeks of treatment, followed by 20 weeks of follow-up.

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 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

36Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
placebo	Experimental	4 administrations at 2-week interval of placebo solution	Drug: placebo
NV1FGF 16 mg	Experimental	4 administrations at 2-week interval of 4mg at each administration	Drug: XRP0038 (NV1FGF)
NV1FGF 32 mg	Experimental	4 administrations at 2-week interval of 8mg at each administration	Drug: XRP0038 (NV1FGF)

Interventions

Name	Type	Description	Arm Group Labels	Other Names
XRP0038 (NV1FGF)	Drug	Pharmaceutical form:solution Route of administration: intramuscular	NV1FGF 16 mg NV1FGF 32 mg

Measure	Description	Time Frame
Change from baseline in Absolute Claudication Distance (ACD) evaluated by treadmill test at week 13		13 weeks

Measure	Description	Time Frame
NV1FGF DNA 69 base pair (bp) in plasma		up to week 27
NV1FGF DNA 825 bp in plasma		up to week 27
FGF-1 in plasma

Eligibility Module

Eligibility Criteria

Inclusion criteria:

Age>40 years
History of typical intermittent claudication lasting for at least 3 months, showing no improvement and consistent with treadmill test findings
Objective evidence of Peripheral Arterial Occlusive Disease. After 10 minutes of rest, either by Ankle brachial index measure (ABI) <0.8 or Systolic ankle pressure (AP) < 50 mmHg or Systolic toe pressure <50 mmHg
Patent femoral inflow above the level of injections recently (<2 weeks) documented either with Doppler ultrasonography or Magnetic Resonance Angiography or Angiography

Exclusion criteria:

Evidence of other causes for leg pain other than intermittent claudication.
Illnesses limiting subject exercise capacity (angina pectoris, heart failure, respiratory disease, orthopaedic disease, neurological disorders…)
Pain at rest
Buerger's disease
Positive serology for HIV 1 or 2, positive serology hepatitis B or C.
Subjects with serum creatinine > 2 mg/dl (176 µmol/l) and subjects on dialysis.
Active proliferative retinopathy defined by the presence of new vessel formation and scarring.
Subjects 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
Pregnant or breast feeding women or who disagree to practice a medically accepted method of birth control. Men and women who do not agree to use condoms as the only accepted protection barrier, for the entire study period
Serious concomitant medical conditions not adequately controlled.
Current alcohol or drug abuse

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

40 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