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Study to Evaluate the Efficacy of Two Treatment Schemes With Antivipmyn ® for the Treatment of Snake Bite Envenomation

NCT00639951 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2016-07-20

No results posted yet for this study

Summary

The purpose of this study is to compare whether a same total dose given up front as a single dose is more effective and as safe as the same dose given as a fractioned dose.

Evaluate the Utility of the the Dry Tube Test Evaluating its Correlation with Coagulation Test Results (fibrinogen, platelets, INR, PT and PTT).

Explore the Evolution of some Serum Markers (CK, DHL, metalloproteinase), Amount of Venom and Antivenom Levels and the Progression of Local Lesions.

Conditions

  • Snake Bite

Interventions

BIOLOGICAL

A

20 vials up front in a Single Dose of Antivipmyn

BIOLOGICAL

Antivipmyn ®

20 vials fractionated into 4 doses of 5 vials each of Antivipmyn ®

Sponsors & Collaborators

  • Instituto Bioclon S.A. de C.V.

    lead INDUSTRY

Principal Investigators

  • Walter García, MD · Instituto Bioclon

  • Anabel Loza, MD · Instituto Bioclon

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
6 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-01-31
Primary Completion
2009-01-31
Completion
2009-03-31

Countries

  • Mexico

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 NCT00639951 on ClinicalTrials.gov