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Safety and Efficacy Study of Recombinant Human Lactoferrin to Treat Severe Sepsis

NCT00630656 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 190

Last updated 2011-08-23

No results posted yet for this study

Summary

Study will evaluate the safety and potential benefit of recombinant human talactoferrin as an addition to the standard care of 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

Placebo given 3 times a day for up to 28 days or until discharge from the intensive care unit

Sponsors & Collaborators

  • Agennix

    lead INDUSTRY

Principal Investigators

  • Kalpalatha K Guntupalli, MD · Baylor College of Medicine

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-04-30
Primary Completion
2009-08-31
Completion
2010-02-28

Countries

  • United States
  • Canada
  • France
  • Germany
  • Spain

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 NCT00630656 on ClinicalTrials.gov