- ICH GCP
- US Clinical Trials Registry
- Clinical Trial 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
Study Overview
Status
Conditions
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.
Study Type
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Locations
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Arizona
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Phoenix, Arizona, United States, 85006
- Banner Good Samaritan Medical Center
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Phoenix, Arizona, United States, 85008
- Maricopa Integrated Health System
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Phoenix, Arizona, United States, 85741
- Northwest Medical Center
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Tucson, Arizona, United States, 85712
- Tucson Medical Center
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Tucson, Arizona, United States, 85713
- University Physicians Hospital
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Tucson, Arizona, United States, 85721
- University Medical Center
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California
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Loma Linda, California, United States, 92354
- Loma Linda University Medical Center
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San Diego, California, United States, 92123
- Rady Children's Hospital
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San Diego, California, United States, 92103
- University of California San Diego
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Florida
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Jacksonsville, Florida, United States, 32209
- Florida Poison Information Center
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Sarasota, Florida, United States, 34239
- Sarasota Memorial Hospital
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Louisiana
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Shreveport, Louisiana, United States, 71103
- LSU Health Sciences Center, Lousiana Poison Control Center
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Missouri
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Kansas City, Missouri, United States, 64108
- The Children's Mercy Hospital
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New Mexico
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Albuquerque, New Mexico, United States, 87106
- The University of New Mexico Hospital
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North Carolina
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Greenville, North Carolina, United States, 27834
- Pitt County Memorial Hospital
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Texas
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Bryan, Texas, United States, 77802
- St. Joseph Regional Health Center
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El Paso, Texas, United States, 79905
- West Texas Regional Poison Center at Thomason Hospital
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Temple, Texas, United States, 76508
- Scott and White Memorial Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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 Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Group 1
Anavip with Anavip Maintenance Therapy
|
Anavip with Anavip Maintenance Therapy
Other Names:
Anavip with Placebo Maintenance Therapy
Other Names:
|
Experimental: Group 2
Anavip with Placebo Maintenance Therapy
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Anavip with Anavip Maintenance Therapy
Other Names:
Anavip with Placebo Maintenance Therapy
Other Names:
|
Active Comparator: Group 3
CroFab with CroFab Maintenance Therapy
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CroFab with CroFab Maintenance Therapy
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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)
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Study Day 5 (±/- 1 day), Study Day 8 (±/- 1 day)
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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)
|
Study Day 5 (+/- 1 day) and Study Day 8 (+/- 1 day)
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Walter Garcia Ubbelohde, MD, Instituto Bioclon
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- YA-07/02
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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