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

• Status: Completed
• Trial end date: 2010-02-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Agennix
• Treatments: Lactoferrin; Talactoferrin alfa

Criteria

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