Snake Bite Clinical Trial
Official title:
A Comparison of Anavip® and CroFab® in the Treatment of Patients With Crotalinae Envenomation: A Randomized, Prospective, Blinded, Controlled, Comparative, Multicenter Study
The purpose of this study is to establish if F(ab)2 antivenom (Anavip) is safe for crotalinae envenomation. Confirm its effectiveness in preventing the occurrence of delayed coagulopathies and compare the safety and efficacy with Fab antivenom (CroFab) in patients with Crotalinae envenomation.
Fewer than 200,000 crotaline envenomations occur annually in the US.Crotaline venoms contain
a broad variety of toxins, venom variability and injection quantity among individual snakes
and across species result in broadly variable patient presentations. Clinical consequences of
crotaline envenomation include local and systemic effects, both of which may progress for
hours to days.The best studied systemic consequence is coagulopathy, which may in its
complexity mimic disseminated intravascular coagulation. Platelet and clotting disorders
respond rapidly to administration of polyvalent antivenom.
Crotaline viper envenomation in the United States is treated with one of two licensed
products: Wyeth Antivenin (Crotalidae) Polyvalent (Polyvalent), or CroFab® (antivenin
Crotalidae polyvalent immune Fab, ovine). In recent years, both of these products have been
in critically short supply. Use of Wyeth Polyvalent has been associated with a greater than
75% incidence of adverse reactions, including acute type 1 and delayed type 2 immune
reactions.These phenomena are an inherent risk in the use of whole immunoglobulin. CroFab´s
low molecular weight creates a pharmacokinetic mismatch with crotaline venom which leds to a
recurrent venom effects.
Anavip is pharmacologically and pharmacokinetically different.Because of the elimination of
the Fc portion of the immunoglobulin molecule, Anavip is expected to produce far fewer
adverse reactions than seen with whole immunoglobulin antivenoms and unlike Fab molecules,
F(ab)2 molecules exceed the size threshold for renal clearance and thus are expected to
remain in circulation for a significantly longer time and substantially reduce the incidence
of recurrent coagulopathy.
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