A Phase 3 interventional study of Crotalinae (pit viper) equine immune F(ab)2 and Crotalinae (pit viper) equine immune F(ab)2 in Snake Bite, sponsored by Instituto Bioclon S.A. de C.V.. Completed at 18 sites in United States. Open to participants aged 2 Years to 80 Years. Per ClinicalTrials.gov, last updated 2012-01-10.
Sponsored by Instituto Bioclon S.A. de C.V. (part of Laboratorios Silanes S.A. de C.V.) · Phase 3, Interventional, and Treatment
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.
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.
38 studies on the registry are indexed under Snake Bites; 11 are open to participants now.
This study's enrollment of 121 is above the median of 70 across 18 interventional studies indexed under Snake Bites.
Browse Snake Bites studies →Instituto Bioclon S.A. de C.V. is the lead sponsor of 11 studies on the registry; none are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Anavip with Anavip Maintenance Therapy
Biological: Crotalinae (pit viper) equine immune F(ab)2
Anavip with Placebo Maintenance Therapy
Biological: Crotalinae (pit viper) equine immune F(ab)2
CroFab with CroFab Maintenance Therapy
Biological: Crotalidae Polyvalent Immune Fab, ovine
Anavip with Anavip Maintenance Therapy
Also known as: Anavip
Anavip with Placebo Maintenance Therapy
Also known as: Anavip
CroFab with CroFab Maintenance Therapy
Also known as: CroFab
Incidence rate of patients experiencing coagulopathy during the follow-up phase of the study. Absolute Platelet levels < 150,000/mm3. Absolute Fibrinogen levels < 150 mg/dL. Clinical coagulopathy requiring additional antivenom.
Time frame: Study Day 5 (±/- 1 day), Study Day 8 (±/- 1 day)
Comparison between groups of: Percentage of patients who experience venonemia. Absolute platelet level measured Lowest absolute platelet level measured Absolute fibrinogen level Lowest absolute fibrinogen level
Time frame: Study Day 5 (+/- 1 day) and Study Day 8 (+/- 1 day)
This study is completed, as verified in Jan 2012. You cannot join it, but the record below documents what was studied.
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