Efficacy and Safety of XRP0038/NV1FGF in Critical Limb Ischemia Patients With Skin Lesions
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.
Timeline
- Start
- 2007-11
- Primary completion
- 2010-08
- Completion
- 2012-08
Outcome
Missed primary endpoint
paper The primary endpoint or components of the primary did not differ between treatment groups, with major amputation or death in 86 patients (33%) PMID 21621834 ↗
paper 96 (36%) in the active group (hazard ratio 1·11, 95% CI 0·83-1·49; p=0·48). PMID 21621834 ↗
Publications
- Results Van Belle E, Nikol S, Norgren L, Baumgartner I, Driver V, Hiatt WR, Belch J. Insights on the role of diabetes and geographic variation in patients with critical limb ischaemia. Eur J Vasc Endovasc Surg. 2011 Sep;42(3):365-73. doi: 10.1016/j.ejvs.2011.04.030. Epub 2011 Jun 21.
- Results Belch J, Hiatt WR, Baumgartner I, Driver IV, Nikol S, Norgren L, Van Belle E; TAMARIS Committees and Investigators. Effect of fibroblast growth factor NV1FGF on amputation and death: a randomised placebo-controlled trial of gene therapy in critical limb ischaemia. Lancet. 2011 Jun 4;377(9781):1929-37. doi: 10.1016/S0140-6736(11)60394-2. Epub 2011 May 28.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | riferminogene pecaplasmid | Other / unclassified | 4 mg | Intramuscular |