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Study of Chimeric Monoclonal Antibodies to Shiga Toxins 1 and 2

NCT01252199 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 45

Last updated 2013-04-25

No results posted yet for this study

Summary

This study is designed to evaluate the safety and efficacy of cαStx1 and cαStx2 administered concomitantly in children presenting early signs of Shiga Toxin-Producing Bacterial (STPB) Infection.

Conditions

  • Shiga Toxin Producing Bacterial Infection

Interventions

DRUG

cαStx1/cαStx2

cαStx1/cαStx2 administered concomitantly at a dose of 1 mg/kg (low dose cohort) or 3 mg/kg (high dose cohort)per antibody over 1 hour + standard of care

DRUG

Placebo

Placebo administered over 1 hour + standard of care

Sponsors & Collaborators

  • LFB Biotechnologies, SAS

    collaborator UNKNOWN

  • Thallion Pharmaceuticals

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
6 Months
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-11-30
Primary Completion
2012-12-31
Completion
2013-02-28

Countries

  • Argentina
  • Chile
  • Peru

Study Locations

More Related Trials

Entities

Drugs

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 NCT01252199 on ClinicalTrials.gov