NCT01157871

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.

Trial Health

90
On Track

Trial Health Score

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

Enrollment
36

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Jun 2004

Shorter than P25 for phase_2

Geographic Reach
4 countries

4 active sites

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2004

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2005

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2005

Completed
4.9 years until next milestone

First Submitted

Initial submission to the registry

July 6, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 7, 2010

Completed
Last Updated

July 7, 2010

Status Verified

July 1, 2010

Enrollment Period

1.2 years

First QC Date

July 6, 2010

Last Update Submit

July 6, 2010

Conditions

Peripheral Arterial Occlusive Disease

Outcome Measures

Primary Outcomes (1)

  • Change from baseline in Absolute Claudication Distance (ACD) evaluated by treadmill test at week 13

    13 weeks

Secondary Outcomes (4)

  • 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

    up to week 27

  • Anti-FGF1 antibodies in serum

    up to week 27

Study Arms (3)

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

XRP0038 (NV1FGF)DRUG

Pharmaceutical form:solution Route of administration: intramuscular

NV1FGF 16 mgNV1FGF 32 mg
placeboDRUG

Pharmaceutical form:solution Route of administration: intramuscular

placebo

Eligibility Criteria

Age40 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Unknown Facility

Minneapolis, Minnesota, United States

Location

Unknown Facility

Brussels, Belgium

Location

Unknown Facility

Münster, Germany

Location

Unknown Facility

Bern, Switzerland

Location

Related Publications (1)

  • 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.

    PMID: 21716303DERIVED

MeSH Terms

Conditions

Peripheral Arterial Occlusive Disease 1

Study Officials

  • International Clinical Development Study Director

    Sanofi

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

July 6, 2010

First Posted

July 7, 2010

Study Start

June 1, 2004

Primary Completion

August 1, 2005

Study Completion

August 1, 2005

Last Updated

July 7, 2010

Record last verified: 2010-07

Locations

DE(1)US(1)CH(1)BE(1)