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

Phase 2
18 Years
Not Enrolling
Severe Sepsis

Thank you

Trial Information

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

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

- 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

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Outcome Measure:

All-cause mortality

Outcome Time Frame:


Safety Issue:


Principal Investigator

Kalpalatha K Guntupalli, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Baylor College of Medicine


United States: Food and Drug Administration

Study ID:




Start Date:

April 2008

Completion Date:

February 2010

Related Keywords:

  • Severe Sepsis
  • sepsis
  • talactoferrin
  • lactoferrin
  • recombinant human lactoferrin
  • Sepsis
  • Toxemia



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