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Treatment Protocol for Use of Anascorp™ in Patients With Scorpion Sting Envenomation

NCT00624078 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 1426

Last updated 2011-02-23

No results posted yet for this study

Summary

This treatment protocol will enable therapeutic use of Anascorp in the management of systemic manifestations of scorpion sting envenomation, in patients for whom antivenom would otherwise be unavailable. The working hypotheses are as follows:

1. The investigational antivenom is safe as treatment of scorpion sting envenomation.
2. The investigational antivenom is effective as treatment of scorpion sting envenomation.

Conditions

  • Scorpion Sting Envenomation

Interventions

DRUG

Antivenin Centruroides (scorpion) F(ab)2 Anascorp™

three vials diluted in 20 to 50 mL normal saline administered intravenously. Subsequent single vial doses of Anascorp, up to a total of five vials administered at thirty minutes intervals until resolution of symptoms.

Sponsors & Collaborators

  • University of Arizona

    collaborator OTHER

  • Instituto Bioclon S.A. de C.V.

    lead INDUSTRY

Principal Investigators

  • Leslie Boyer, M.D · VIPER Institute

  • Walter Garcia, M.D · Instituto Bioclon S.A. de C.V.

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-05-31
Primary Completion
2010-09-30
Completion
2010-09-30

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 NCT00624078 on ClinicalTrials.gov