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
1 other identifier
interventional
121
1 country
18
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 the safety and efficacy with Fab antivenom (CroFab) in patients with Crotalinae envenomation.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started May 2008
Typical duration for phase_3
18 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 11, 2008
CompletedFirst Posted
Study publicly available on registry
March 14, 2008
CompletedStudy Start
First participant enrolled
May 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2012
CompletedJanuary 10, 2012
January 1, 2012
3.5 years
March 11, 2008
January 9, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
Study Day 5 (±/- 1 day), Study Day 8 (±/- 1 day)
Secondary Outcomes (1)
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
Study Day 5 (+/- 1 day) and Study Day 8 (+/- 1 day)
Study Arms (3)
Group 1
EXPERIMENTALAnavip with Anavip Maintenance Therapy
Group 2
EXPERIMENTALAnavip with Placebo Maintenance Therapy
Group 3
ACTIVE COMPARATORCroFab with CroFab Maintenance Therapy
Interventions
Anavip with Anavip Maintenance Therapy
CroFab with CroFab Maintenance Therapy
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Instituto Bioclon S.A. de C.V.lead
- Universidad Nacional Autonoma de Mexicocollaborator
- University of Arizonacollaborator
Study Sites (18)
Banner Good Samaritan Medical Center
Phoenix, Arizona, 85006, United States
Maricopa Integrated Health System
Phoenix, Arizona, 85008, United States
Northwest Medical Center
Phoenix, Arizona, 85741, United States
Tucson Medical Center
Tucson, Arizona, 85712, United States
University Physicians Hospital
Tucson, Arizona, 85713, United States
University Medical Center
Tucson, Arizona, 85721, United States
Loma Linda University Medical Center
Loma Linda, California, 92354, United States
University of California San Diego
San Diego, California, 92103, United States
Rady Children's Hospital
San Diego, California, 92123, United States
Florida Poison Information Center
Jacksonsville, Florida, 32209, United States
Sarasota Memorial Hospital
Sarasota, Florida, 34239, United States
LSU Health Sciences Center, Lousiana Poison Control Center
Shreveport, Louisiana, 71103, United States
The Children's Mercy Hospital
Kansas City, Missouri, 64108, United States
The University of New Mexico Hospital
Albuquerque, New Mexico, 87106, United States
Pitt County Memorial Hospital
Greenville, North Carolina, 27834, United States
St. Joseph Regional Health Center
Bryan, Texas, 77802, United States
West Texas Regional Poison Center at Thomason Hospital
El Paso, Texas, 79905, United States
Scott and White Memorial Hospital
Temple, Texas, 76508, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Walter García Ubbelohde, MD
Instituto Bioclon
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 11, 2008
First Posted
March 14, 2008
Study Start
May 1, 2008
Primary Completion
November 1, 2011
Study Completion
January 1, 2012
Last Updated
January 10, 2012
Record last verified: 2012-01