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A Comparison of Crotalinae (Pit Viper) Equine Immune F(ab)2 Antivenom (Anavip) and Crotalidae Polyvalent Immune Fab, Ovine Antivenom (CroFab) in the Treatment of Pit Viper Envenomation

This study has been completed.
Sponsor:
Collaborator:
University of Arizona
Information provided by:
Instituto Bioclon S.A. de C.V.
ClinicalTrials.gov Identifier:
NCT00868309
First received: November 6, 2008
Last updated: April 3, 2009
Last verified: April 2009
Results First Received: November 6, 2008  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Snake Bite
Blood Coagulation Disorders
Interventions: Biological: Antivenin Crotalinae (pit viper) equine immune F(ab)2
Biological: CroFab

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Subjects arriving at participating centers with a pit viper bite were evaluated with respect to the inclusion/exclusion criteria.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Anavip Crotalinae (Pit Viper) Equine Immune F(ab)2 Antivenom Anavip, 10 vials IV every 2 hours until initial control has been achieved; then 3 maintenance doses of 4 vials every 6 hrs
CroFab Crotalidae Polyvalent Immune Fab, Ovine Antivenom CroFab, 5 vials IV every 2 hours until initial control has been achieved; then 3 maintenance doses of 2 vials every 6 hrs

Participant Flow:   Overall Study
    Anavip Crotalinae (Pit Viper) Equine Immune F(ab)2 Antivenom     CroFab Crotalidae Polyvalent Immune Fab, Ovine Antivenom  
STARTED     6     6  
COMPLETED     6     6  
NOT COMPLETED     0     0  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Anavip Crotalinae (Pit Viper) Equine Immune F(ab)2 Antivenom Anavip, 10 vials IV every 2 hours until initial control has been achieved; then 3 maintenance doses of 4 vials every 6 hrs
CroFab Crotalidae Polyvalent Immune Fab, Ovine Antivenom CroFab, 5 vials IV every 2 hours until initial control has been achieved; then 3 maintenance doses of 2 vials every 6 hrs
Total Total of all reporting groups

Baseline Measures
    Anavip Crotalinae (Pit Viper) Equine Immune F(ab)2 Antivenom     CroFab Crotalidae Polyvalent Immune Fab, Ovine Antivenom     Total  
Number of Participants  
[units: participants]
  6     6     12  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     6     6     12  
>=65 years     0     0     0  
Age  
[units: years]
Mean ± Standard Deviation
  50.2  ± 4.8     40.7  ± 16.5     45.3  ± 12.6  
Gender  
[units: participants]
     
Female     5     1     6  
Male     1     5     6  



  Outcome Measures
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1.  Primary:   Detection of Plasma Venom Levels During the Post Acute Treatment Period.   [ Time Frame: Follow up after Maintenance doses were completed. Two Weeks. ]

2.  Secondary:   Thrombocytopenia During Follow up Period. Two Weeks.   [ Time Frame: Follow up after maintenance dose ]


  Serious Adverse Events


  Other Adverse Events
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Time Frame No text entered.
Additional Description No text entered.

Frequency Threshold
Threshold above which other adverse events are reported   16%  

Reporting Groups
  Description
Anavip Crotalinae (Pit Viper) Equine Immune F(ab)2 Antivenom Anavip, 10 vials IV every 2 hours until initial control has been achieved; then 3 maintenance doses of 4 vials every 6 hrs
CroFab Crotalidae Polyvalent Immune Fab, Ovine Antivenom CroFab, 5 vials IV every 2 hours until initial control has been achieved; then 3 maintenance doses of 2 vials every 6 hrs

Other Adverse Events
    Anavip Crotalinae (Pit Viper) Equine Immune F(ab)2 Antivenom     CroFab Crotalidae Polyvalent Immune Fab, Ovine Antivenom  
Total, other (not including serious) adverse events      
# participants affected     3     3  
Gastrointestinal disorders      
Nausea    
# participants affected / at risk     0/6 (0.00%)     2/6 (33.33%)  
# events     0     2  
Vomiting    
# participants affected / at risk     0/6 (0.00%)     2/6 (33.33%)  
# events     0     2  
Diarrhea    
# participants affected / at risk     0/6 (0.00%)     1/6 (16.67%)  
# events     0     1  
Rectal Hemorrhage    
# participants affected / at risk     1/6 (16.67%)     0/6 (0.00%)  
# events     1     0  
General disorders      
Chills    
# participants affected / at risk     1/6 (16.67%)     1/6 (16.67%)  
# events     1     1  
Chest discomfort    
# participants affected / at risk     1/6 (16.67%)     0/6 (0.00%)  
# events     1     0  
Puncture site hemorrhage    
# participants affected / at risk     0/6 (0.00%)     1/6 (16.67%)  
# events     0     1  
Musculoskeletal and connective tissue disorders      
Arthralgia    
# participants affected / at risk     0/6 (0.00%)     1/6 (16.67%)  
# events     0     1  
Myalgia    
# participants affected / at risk     0/6 (0.00%)     1/6 (16.67%)  
# events     0     1  
Skin and subcutaneous tissue disorders      
Rash    
# participants affected / at risk     1/6 (16.67%)     0/6 (0.00%)  
# events     1     0  
Events were collected by systematic assessment



  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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