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.

Phase 3 Multicenter Comparative Study to Confirm Safety and Effectiveness of the F(ab)2 Antivenom Anavip.

Snake Bite

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.

Crotalinae (pit viper) equine immune F(ab)2

Crotalidae Polyvalent Immune Fab, ovine

A Comparison of Anavip® and CroFab® in the Treatment of Patients With Crotalinae Envenomation: A Randomized, Prospective, Blinded, Controlled, Comparative, Multicenter Study

Banner Good Samaritan Medical Center

Maricopa Integrated Health System

Northwest Medical Center

Tucson Medical Center

University Physicians Hospital

University Medical Center

Loma Linda University Medical Center

University of California San Diego

Rady Children's Hospital

Florida Poison Information Center

Sarasota Memorial Hospital

LSU Health Sciences Center, Lousiana Poison Control Center

The Children's Mercy Hospital

The University of New Mexico Hospital

Pitt County Memorial Hospital

St. Joseph Regional Health Center

West Texas Regional Poison Center at Thomason Hospital

Scott and White Memorial Hospital

Phase 3 Multicenter Comparative Study to Confirm Safety and Effectiveness of the F(ab)2 Antivenom Anavip.

About this trial

Study ID

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Type

Phase

Placebo

Accepting

Not accepting

Trial Timing

What is this trial about?

What are the participation requirements?

Locations

Location

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