NCT00636116

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

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 121 (actual)
• Sponsor: Instituto Bioclon S.A. de C.V. · Industry
• Sex: All
• Age: 2 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Snake Bite

Interventions

Type	Name	Description
BIOLOGICAL	Crotalinae (pit viper) equine immune F(ab)2	Anavip with Anavip Maintenance Therapy
BIOLOGICAL	Crotalinae (pit viper) equine immune F(ab)2	Anavip with Placebo Maintenance Therapy
BIOLOGICAL	Crotalidae Polyvalent Immune Fab, ovine	CroFab with CroFab Maintenance Therapy

Timeline

• Start date: 2008-05-01
• Primary completion: 2011-11-01
• Completion: 2012-01-01
• First posted: 2008-03-14
• Last updated: 2012-01-10

Locations

18 sites across 1 country: United States