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Phase 3 Multicenter Comparative Study to Confirm Safety and Effectiveness of the F(ab)2 Antivenom Anavip.

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ClinicalTrials.gov Identifier: NCT00636116
Recruitment Status : Completed
First Posted : March 14, 2008
Last Update Posted : January 10, 2012
Sponsor:
Collaborators:
Universidad Nacional Autonoma de Mexico
University of Arizona
Information provided by (Responsible Party):
Instituto Bioclon S.A. de C.V.

Tracking Information
First Submitted Date  ICMJE March 11, 2008
First Posted Date  ICMJE March 14, 2008
Last Update Posted Date January 10, 2012
Study Start Date  ICMJE May 2008
Actual Primary Completion Date November 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 11, 2008)
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) ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT00636116 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: March 11, 2008)
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) ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Phase 3 Multicenter Comparative Study to Confirm Safety and Effectiveness of the F(ab)2 Antivenom Anavip.
Official Title  ICMJE A Comparison of Anavip® and CroFab® in the Treatment of Patients With Crotalinae Envenomation: A Randomized, Prospective, Blinded, Controlled, Comparative, Multicenter Study
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.
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  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Snake Bite
Intervention  ICMJE
  • Biological: Crotalinae (pit viper) equine immune F(ab)2
    Anavip with Anavip Maintenance Therapy
    Other Name: Anavip
  • Biological: Crotalinae (pit viper) equine immune F(ab)2
    Anavip with Placebo Maintenance Therapy
    Other Name: Anavip
  • Biological: Crotalidae Polyvalent Immune Fab, ovine
    CroFab with CroFab Maintenance Therapy
    Other Name: CroFab
Study Arms  ICMJE
  • Experimental: Group 1
    Anavip with Anavip Maintenance Therapy
    Intervention: Biological: Crotalinae (pit viper) equine immune F(ab)2
  • Experimental: Group 2
    Anavip with Placebo Maintenance Therapy
    Intervention: Biological: Crotalinae (pit viper) equine immune F(ab)2
  • Active Comparator: Group 3
    CroFab with CroFab Maintenance Therapy
    Intervention: Biological: Crotalidae Polyvalent Immune Fab, ovine
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 9, 2012)
121
Original Estimated Enrollment  ICMJE
 (submitted: March 11, 2008)
93
Actual Study Completion Date  ICMJE January 2012
Actual Primary Completion Date November 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 2 Years to 80 Years   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00636116
Other Study ID Numbers  ICMJE YA-07/02
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Instituto Bioclon S.A. de C.V.
Study Sponsor  ICMJE Instituto Bioclon S.A. de C.V.
Collaborators  ICMJE
  • Universidad Nacional Autonoma de Mexico
  • University of Arizona
Investigators  ICMJE
Study Director: Walter García Ubbelohde, MD Instituto Bioclon
PRS Account Instituto Bioclon S.A. de C.V.
Verification Date January 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP