drugset / Trial / NCT00639951

Study to Evaluate the Efficacy of Two Treatment Schemes With Antivipmyn ® for the Treatment of Snake Bite Envenomation

NCT00639951 ↗

Phase 4 Terminated 10 enrolled Instituto Bioclon S.A. de C.V.
RandomizedParallel-groupOpen-labelTreatment

Summary

The purpose of this study is to compare whether a same total dose given up front as a single dose is more effective and as safe as the same dose given as a fractioned dose. Evaluate the Utility of the the Dry Tube Test Evaluating its Correlation with Coagulation Test Results (fibrinogen, platelets, INR, PT and PTT). Explore the Evolution of some Serum Markers (CK, DHL, metalloproteinase), Amount of Venom and Antivenom Levels and the Progression of Local Lesions.

Timeline

Start
2008-01
Primary completion
2009-01
Completion
2009-03

Outcome

Outcome not reported

Stopped: “Administrative reasons”

Drugs

EvaluationDrugModalityDoseRoute
Comparator Antivipmyn Protein / enzyme biologic 5 unknown Intravenous
Comparator Antivipmyn Protein / enzyme biologic 20 unknown Intravenous