Status:
COMPLETED
A Comparison of Crotalinae Equine Immune F(ab)2 Antivenom (Anavip) and Crotalidae Polyvalent Immune Fab,
Lead Sponsor:
Instituto Bioclon S.A. de C.V.
Collaborating Sponsors:
University of Arizona
Conditions:
Snake Bite
Blood Coagulation Disorders
Eligibility:
All Genders
18-70 years
Phase:
PHASE2
Brief Summary
This phase II study was a prospective, randomized, open-label, multi-center study in the United States, involving patients from 18 to 70 years of age, comparing Anavip (Antivenin Crotalinae \[pit vipe...
Detailed Description
The overall objective of this Phase 2 open-label comparative study was to demonstrate that the F(ab)2 antivenom Anavip has significantly longer plasma persistence than does Fab, and that this is assoc...
Eligibility Criteria
Inclusion
- men and women 18 to 70 years of age
- presenting for emergency treatment of pit viper bite
- informed consent document read and signed by subject
Exclusion
- allergy to horse serum, sheep serum, or papaya
- current use of any antivenom, or use within the last month
- current participation in a clinical drug study, or participation within the last month
- pregnancy or breast-feeding
- underlying medical conditions that significantly alter blood coagulation: thrombocytopenia, hemophilia, familial dysfibrinogenemia, leukemia, recent ingestion of superwarfarin compounds (rat poison)
- use of any medication expected to affect platelet count, coagulation factors, or fibrinogen: chemotherapeutic agents, warfarin, heparin, aspirin
- No clinical indications of snake bite envenomation
Key Trial Info
Start Date :
January 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2007
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT00868309
Start Date
January 1 2005
End Date
February 1 2007
Last Update
April 18 2016
Active Locations (1)
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1
Tucson snakebite investigational site
Tucson, Arizona, United States, 85724