A Comparison of Crotalinae Equine Immune F(ab)2 Antivenom (Anavip) and Crotalidae Polyvalent Immune Fab,

This study has been completed.
Sponsor:
Collaborator:
University of Arizona
Information provided by (Responsible Party):
Instituto Bioclon S.A. de C.V.
ClinicalTrials.gov Identifier:
NCT00868309
First received: November 6, 2008
Last updated: March 18, 2016
Last verified: March 2016
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: Anavip
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:   >50,000 Platelets/mm3   [ 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   5%  

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 / at risk     6/6 (100.00%)     6/6 (100.00%)  
Blood and lymphatic system disorders      
thrombocytopenia    
# participants affected / at risk     0/6 (0.00%)     2/6 (33.33%)  
# events     0     2  
anaemia    
# participants affected / at risk     0/6 (0.00%)     1/6 (16.67%)  
# events     0     1  
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  
constipation    
# participants affected / at risk     0/6 (0.00%)     1/6 (16.67%)  
# events     0     1  
diarrhoea    
# participants affected / at risk     0/6 (0.00%)     1/6 (16.67%)  
# events     0     1  
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  
axillary pain    
# participants affected / at risk     1/6 (16.67%)     0/6 (0.00%)  
# events     1     0  
fatigue    
# participants affected / at risk     1/6 (16.67%)     0/6 (0.00%)  
# events     1     0  
hypoaesthesia    
# participants affected / at risk     1/6 (16.67%)     0/6 (0.00%)  
# events     1     0  
Investigations      
body temperature increased    
# participants affected / at risk     0/6 (0.00%)     1/6 (16.67%)  
# events     0     1  
Metabolism and nutrition disorders      
anorexia    
# participants affected / at risk     1/6 (16.67%)     0/6 (0.00%)  
# events     1     0  
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  
musculoskeletal discomfort    
# participants affected / at risk     1/6 (16.67%)     0/6 (0.00%)  
# events     1     0  
Nervous system disorders      
migraine    
# participants affected / at risk     0/6 (0.00%)     1/6 (16.67%)  
# events     0     1  
burning sensation    
# participants affected / at risk     0/6 (0.00%)     1/6 (16.67%)  
# events     0     1  
headache    
# participants affected / at risk     1/6 (16.67%)     0/6 (0.00%)  
# events     1     0  
paraesthesia    
# participants affected / at risk     1/6 (16.67%)     0/6 (0.00%)  
# events     1     0  
tremor    
# participants affected / at risk     0/6 (0.00%)     1/6 (16.67%)  
# events     0     1  
Psychiatric disorders      
insomnia    
# participants affected / at risk     1/6 (16.67%)     3/6 (50.00%)  
# events     1     3  
Reproductive system and breast disorders      
genital pruritus female    
# participants affected / at risk     1/6 (16.67%)     0/6 (0.00%)  
# events     1     0  
Skin and subcutaneous tissue disorders      
Rash    
# participants affected / at risk     1/6 (16.67%)     3/6 (50.00%)  
# events     1     3  
ecchymosis    
# participants affected / at risk     1/6 (16.67%)     0/6 (0.00%)  
# events     1     0  
dry skin    
# participants affected / at risk     1/6 (16.67%)     0/6 (0.00%)  
# events     1     0  
dermatitis contact    
# participants affected / at risk     1/6 (16.67%)     0/6 (0.00%)  
# events     1     0  
pruritus generalised    
# participants affected / at risk     0/6 (0.00%)     2/6 (33.33%)  
# events     0     2  
hyperhidrosis    
# participants affected / at risk     2/6 (33.33%)     0/6 (0.00%)  
# events     2     0  
petechiae    
# participants affected / at risk     0/6 (0.00%)     2/6 (33.33%)  
# events     0     2  
erythema    
# participants affected / at risk     0/6 (0.00%)     2/6 (33.33%)  
# events     0     2  
pruritus    
# participants affected / at risk     2/6 (33.33%)     5/6 (83.33%)  
# events     2     5  
Vascular disorders      
hypotension    
# participants affected / at risk     0/6 (0.00%)     1/6 (16.67%)  
# events     0     1  
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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