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Safety and Efficacy of Talactoferrin Alfa in Patients With Severe Sepsis

NCT01273779 · Status: SUSPENDED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 1280

Last updated 2012-02-03

No results posted yet for this study

Summary

Study will evaluate the safety and potential benefit of talactoferrin (recombinant human lactoferrin) as an addition to the standard care for severe sepsis.

Conditions

  • Severe Sepsis

Interventions

DRUG

Talactoferrin alfa

15 mL of an oral solution of 100mg/mL (1.5 g) given 3 times a day for up to 28 days or until discharge from the intensive care unit

DRUG

Placebo

15 mL of oral solution of placebo given 3 times a day for up to 28 days or until discharge from the intensive care unit

Sponsors & Collaborators

  • Agennix

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-06-30
Primary Completion
2014-01-31
Completion
2014-12-31

Countries

  • United States
  • Belgium
  • Canada
  • Denmark
  • France
  • Germany
  • Israel
  • Netherlands
  • Spain
  • United Kingdom

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 NCT01273779 on ClinicalTrials.gov