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

NCT00636116 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 121

Last updated 2012-01-10

No results posted yet for this study

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.

Conditions

  • Snake Bite

Interventions

BIOLOGICAL

Crotalinae (pit viper) equine immune F(ab)2

Anavip with Anavip Maintenance Therapy

BIOLOGICAL

Crotalinae (pit viper) equine immune F(ab)2

Anavip with Placebo Maintenance Therapy

BIOLOGICAL

Crotalidae Polyvalent Immune Fab, ovine

CroFab with CroFab Maintenance Therapy

Sponsors & Collaborators

  • Universidad Nacional Autonoma de Mexico

    collaborator OTHER

  • University of Arizona

    collaborator OTHER

  • Instituto Bioclon S.A. de C.V.

    lead INDUSTRY

Principal Investigators

  • Walter García Ubbelohde, MD · Instituto Bioclon

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
2 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-05-31
Primary Completion
2011-11-30
Completion
2012-01-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00636116 on ClinicalTrials.gov