Status:
COMPLETED
Phase 3 Multicenter Comparative Study to Confirm Safety and Effectiveness of the F(ab)2 Antivenom Anavip.
Lead Sponsor:
Instituto Bioclon S.A. de C.V.
Collaborating Sponsors:
Universidad Nacional Autonoma de Mexico
University of Arizona
Conditions:
Snake Bite
Eligibility:
All Genders
2-80 years
Phase:
PHASE3
Brief 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...
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 spec...
Eligibility Criteria
Inclusion
- Men and women 2 to 80 years of age
- Presenting for emergency treatment of pit viper bite
- Informed consent document read and signed by patient (or parent/legal guardian)
Exclusion
- Current use of any antivenom, or use within the last month
- Current participation in a clinical drug study, or participation within the last month
- Positive urine or blood pregnancy test at screening
- Breast-feeding
- Allergy to horse serum, sheep serum, or papaya
- Underlying medical conditions that significantly alter platelet count or fibrinogen; thrombocytopenia, hemophilia, familial dysfibrinogenemia, leukemia
- Use of any medication expected to affect platelet count, coagulation factors or fibrinogen: chemotherapeutic agents, warfarin, heparin
- No clinical indications of snake bite requiring antivenom for treatment
Key Trial Info
Start Date :
May 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2012
Estimated Enrollment :
121 Patients enrolled
Trial Details
Trial ID
NCT00636116
Start Date
May 1 2008
End Date
January 1 2012
Last Update
January 10 2012
Active Locations (18)
Enter a location and click search to find clinical trials sorted by distance.
1
Banner Good Samaritan Medical Center
Phoenix, Arizona, United States, 85006
2
Maricopa Integrated Health System
Phoenix, Arizona, United States, 85008
3
Northwest Medical Center
Phoenix, Arizona, United States, 85741
4
Tucson Medical Center
Tucson, Arizona, United States, 85712