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

This study has been completed.
Information provided by (Responsible Party):
Agennix Identifier:
First received: February 28, 2008
Last updated: August 18, 2011
Last verified: August 2011

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

Condition Intervention Phase
Severe Sepsis
Drug: Talactoferrin alfa
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Phase 2 Randomized, Double-blind, Placebo-controlled Study of the Safety and Efficacy of Talactoferrin Alfa in Patients With Severe Sepsis

Resource links provided by NLM:

Further study details as provided by Agennix:

Primary Outcome Measures:
  • All-cause mortality [ Time Frame: 28-day ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • All-cause mortality [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • All-cause mortality [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Enrollment: 190
Study Start Date: April 2008
Study Completion Date: February 2010
Primary Completion Date: August 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Talactoferrin alfa
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
Placebo Comparator: 2
Drug: Placebo
Placebo given 3 times a day for up to 28 days or until discharge from the intensive care unit


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
Please refer to this study by its identifier: NCT00630656

  Show 34 Study Locations
Sponsors and Collaborators
Principal Investigator: Kalpalatha K Guntupalli, MD Baylor College of Medicine
  More Information

No publications provided by Agennix

Additional publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Agennix Identifier: NCT00630656     History of Changes
Other Study ID Numbers: LF-0801, NIH grant 1R44GM077816-01A2
Study First Received: February 28, 2008
Last Updated: August 18, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Agennix:
recombinant human lactoferrin

Additional relevant MeSH terms:
Systemic Inflammatory Response Syndrome
Pathologic Processes processed this record on April 14, 2014