A Phase 3 interventional study of Ancrod (Viprinex) and Placebo in Stroke, Cerebral Ischemia and Brain Infarction, sponsored by Neurobiological Technologies. Terminated at 100 sites in 10 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2009-12-23.
Sponsored by Neurobiological Technologies · Phase 3, Interventional, and Treatment
The primary purpose of this study is to determine whether a brief intravenous infusion of ancrod started within 6 hours of stroke onset improves functional outcome at 3 months.
With prior approval by the FDA, an interim analysis for futility was performed when 500 subjects had been entered into the two parallel trials, NCT00141001 and NCT00300196. The analyses were reviewed by the data safety monitoring board, which recommended that both studies be terminated because of futility. This was done at a point where 650 subjects had been entered into both studies, combined, but analyses were conducted only on the initial 500 subjects. Results of the abbreviated analysis will be found with study NCT00141001 since that study contributed most of the subjects to the analysis.
7,286 studies on the registry are indexed under Stroke; 2,007 are open to participants now.
This study's enrollment of 277 is above the median of 50 across 5,369 interventional studies indexed under Stroke.
Browse Stroke studies →Neurobiological Technologies is the lead sponsor of 2 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Intravenous ancrod infused at a rate of 0.167 IU/kg/hr (0.6 mL/kg/hr) for 2 or 3 hours depending on the pretreatment fibrinogen level.
Drug: Ancrod (Viprinex)
Intravenous placebo at a rate of 0.6 mL/kg/hr for 2 or 3 hours depending on the pretreatment fibrinogen level.
Drug: Placebo
0.167 IU/kg/hr (0.6 mL/kg/hr) IV for 2-3 hours
0.6 mL/kg/hr
Responder analysis based on Modified Rankin Scale (mRS)
Time frame: 90 days
National Institute of Health Stroke Scale (NIHSS),Barthel Index (BI),Fibrinogen levels with ancrod tx, and Safety of ancrod tx
Time frame: 90 days
This study is terminated, as verified in Dec 2009. You cannot join it, but the record below documents what was studied.
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Neurobiological Technologies