Skip to main content
OpenTrials
Completed

NCT Number: NCT00630656

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

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Severe Sepsis Infections Inflammation Pathologic Processes Pathological Conditions, Signs and Symptoms Sepsis Systemic Inflammatory Response Syndrome

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Vancouver General Hospital, Vancouver, British Columbia, Canada

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age greater than or equal to 18 years
  • Onset of severe sepsis within the previous 24 hours
  • Must be receiving antibiotic therapy
  • Informed consent form signed by patient, legal next-of-kin or legal guardian
  • Able to take medication by mouth or feeding tube

Exclusion criteria

  • Receipt of investigational medication within 4 weeks prior to participation in the study
  • Pregnant or breast-feeding
  • Severe congestive heart failure
  • Known severe HIV infection
  • Presence of severe burns
  • Patients on high dose immunosuppressants
  • Patients whose death is considered imminent
  • Patients whose life expectancy for concurrent illness is less than 6 months
  • Severe hypoxic encephalopathy or persistent vegetative state
  • Severe liver disease
  • Patient, legal representative or patient's primary physician not committed to providing full, aggressive life support

Treatment and study plan

Talactoferrin alfa

Drug

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

Placebo

Drug

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

Primary outcomes

  1. All-cause mortality

    Time frame: 28-day

Secondary outcomes

  1. All-cause mortality

    Time frame: 3 months

  2. All-cause mortality

    Time frame: 6 months

Sponsors and collaborators

Lead sponsor

Agennix

Industry

Registry information

Official study title

A Phase 2 Randomized, Double-blind, Placebo-controlled Study of the Safety and Efficacy of Talactoferrin Alfa in Patients With Severe Sepsis

Important dates

Study start
2008
Primary completion
2009
Study completion
2010
First posted
Mar 7, 2008
Registry last updated
Aug 23, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.