NCT00368797

Brief Summary

This study is a double-blind study to evaluate the efficacy and safety of NV1FGF, a pCOR plasmid constructed by inserting the gene coding for the FGF compared to placebo in patients with severe Peripheral Arterial Occlusive Disease, Fontaine's stage IV. The efficacy was assessed by the complete healing of at least one ulcer in the treated limb, 25 week post-baseline and secondary by the rate of amputation and death.

Trial Health

93
On Track

Trial Health Score

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

Enrollment
125

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Mar 2002

Typical duration for phase_2

Geographic Reach
6 countries

6 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

March 1, 2002

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2005

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2005

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

August 24, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 25, 2006

Completed
Last Updated

November 18, 2008

Status Verified

November 1, 2008

Enrollment Period

3.1 years

First QC Date

August 24, 2006

Last Update Submit

November 14, 2008

Conditions

Peripheral Arterial Disease

Keywords

Gene TherapyPAODCLI

Outcome Measures

Primary Outcomes (2)

  • Primary efficacy parameter: ulcer healing.

  • Ulcers will be evaluated at each visit primarily by collecting quantitative and qualitative information.

Secondary Outcomes (4)

  • Hemodynamic parameters:ABI, TcPO2

  • Pain

  • Amputation (Date of amputation, Indication for amputation, amputation level (minor and major)

  • Death

Interventions

XRP0038 (NV1FGF)DRUG

Eligibility Criteria

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

You may qualify if:

  • Outpatients with severe Peripheral Artery Occlusive Disease defined as Rutherford's Grade III, category 5 or 6, or Fontaine's stage IV.
  • 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 (resting ankle pressure \< 70 mmHg and/or toe pressure \< 50 mmHg, and/or resting ankle-brachial index (ABI) \< 0.4 and/or resting toe-brachial index (TBI) \< 0.3 and/or metatarsal pulse volume recording (PVR) flat or barely pulsatile) in the diseased limb on two consecutive examinations performed at least 1 week apart.
  • Demonstration or documentation (historical data not older than 6 months prior to first study treatment administration) 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.
  • Life expectancy \> 6 months from the first study treatment administration.
  • Poor/not candidates for revascularization (patients suitable for revascularization but with a high risk of failure/ amputation/ or patients not suitable for revascularization).

You may not qualify if:

  • Suspicion of malignant disease (abnormal X ray,positive. stool hemoccult, positive Prostate Specific Antigen , abnormal mammography, papanicolaou smear of Class IV or Class V characterization.
  • Lower extremity surgery : bypass/angioplasty of the leg to be treated within 2 months prior to the first administration of study treatment (Day 1).
  • Active proliferative retinopathy.
  • Buerger's disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Ghent University Hospital

Ghent, Belgium

Location

Hôpital Européen Georges Pompidou

Paris, France

Location

Klinikum Karlsbad-Langensteinbach

Karlsbad, Germany

Location

Istituto Dermopatico dell'Immacolata

Roma, Italy

Location

Universitätsklinik

Bern, Switzerland

Location

St George's Hospital

London, United Kingdom

Location

Related Publications (2)

  • Nikol S, Baumgartner I, Van Belle E, Diehm C, Visona A, Capogrossi MC, Ferreira-Maldent N, Gallino A, Wyatt MG, Wijesinghe LD, Fusari M, Stephan D, Emmerich J, Pompilio G, Vermassen F, Pham E, Grek V, Coleman M, Meyer F; TALISMAN 201 investigators. Therapeutic angiogenesis with intramuscular NV1FGF improves amputation-free survival in patients with critical limb ischemia. Mol Ther. 2008 May;16(5):972-8. doi: 10.1038/mt.2008.33. Epub 2008 Apr 1.

    PMID: 18388929RESULT

  • 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

Related Links

MeSH Terms

Conditions

Peripheral Arterial Disease

Condition Hierarchy (Ancestors)

AtherosclerosisArteriosclerosisArterial Occlusive DiseasesVascular DiseasesCardiovascular DiseasesPeripheral Vascular Diseases

Study Officials

  • Sigrid NIKOL, Prof.

    Universitätsklinikum Münster

    PRINCIPAL INVESTIGATOR

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

August 24, 2006

First Posted

August 25, 2006

Study Start

March 1, 2002

Primary Completion

April 1, 2005

Study Completion

April 1, 2005

Last Updated

November 18, 2008

Record last verified: 2008-11

Locations

GB(1)DE(1)CH(1)BE(1)IT(1)FR(1)