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Sponsors and Collaborators: |
Instituto Bioclon S.A. de C.V. Instituto de Biotecnologia,UNAM, Cuernavaca Mexico University of Arizona |
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Information provided by: | Instituto Bioclon S.A. de C.V. |
ClinicalTrials.gov Identifier: | NCT00636116 |
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.
Condition | Intervention | Phase |
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Snake Bite |
Biological: Crotalinae (pit viper) equine immune F(ab)2 Biological: Crotalidae Polyvalent Immune Fab, ovine |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Comparison of Anavip® and CroFab® in the Treatment of Patients With Crotalinae Envenomation: A Randomized, Prospective, Blinded, Controlled, Comparative, Multicenter Study |
Estimated Enrollment: | 93 |
Study Start Date: | May 2008 |
Estimated Study Completion Date: | March 2009 |
Estimated Primary Completion Date: | November 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Group 1: Experimental
Anavip with Anavip Maintenance Therapy
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Biological: Crotalinae (pit viper) equine immune F(ab)2
Anavip with Anavip Maintenance Therapy
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Group 2: Experimental
Anavip with Placebo Maintenance Therapy
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Biological: Crotalinae (pit viper) equine immune F(ab)2
Anavip with Placebo Maintenance Therapy
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Group 3: Active Comparator
CroFab with CroFab Maintenance Therapy
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Biological: Crotalidae Polyvalent Immune Fab, ovine
CroFab with CroFab Maintenance Therapy
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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.
Ages Eligible for Study: | 2 Years to 80 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Walter García, MD | (5255)54883700 ext 3785 | wgarcia@silanes.com.mx |
Contact: Charles Perry | (615)4147270 | cperry@raretx.com |
United States, Arizona | |
Tucson site | Not yet recruiting |
Tucson, Arizona, United States, 85741 | |
United States, California | |
San Diego site | Not yet recruiting |
San Diego, California, United States, 92103 | |
United States, Missouri | |
Kansas City site | Recruiting |
Kansas City, Missouri, United States, 64108 | |
United States, New Mexico | |
Albuquerque site | Recruiting |
Albuquerque, New Mexico, United States, 87106 | |
United States, North Carolina | |
Greenville site | Recruiting |
Greenville, North Carolina, United States, 27834 | |
United States, Oklahoma | |
Tulsa site | Not yet recruiting |
Tulsa, Oklahoma, United States, 74136 | |
United States, Texas | |
Temple site | Recruiting |
Temple, Texas, United States, 76508 | |
El Paso site | Not yet recruiting |
El Paso, Texas, United States, 79905 | |
San Antonio site | Not yet recruiting |
San Antonio, Texas, United States, 78229 |
Principal Investigator: | Alejandro Alagon Cano, PhD | Instituto de Biotecnología UNAM |
Study Director: | Walter García Ubbelohde, MD | Instituto Bioclon/Laboratorios Silanes |
Principal Investigator: | Leslie Boyer, MD | Viper Institute, UoA |
Responsible Party: | Instituto Bioclon S.A. de C.V. ( Walter García Ubbelohde, Clinical Research Manager ) |
Study ID Numbers: | YA-07/02 |
Study First Received: | March 11, 2008 |
Last Updated: | November 4, 2008 |
ClinicalTrials.gov Identifier: | NCT00636116 History of Changes |
Health Authority: | United States: Food and Drug Administration |
snake bite antivenin treatment |
Antivenins Poisoning Disorders of Environmental Origin Bites and Stings Snake Bites |
Poisoning Disorders of Environmental Origin Bites and Stings Snake Bites |