Safety and Efficacy of Talactoferrin Alfa in Patients With Severe Sepsis

• Status: Suspended
• Trial end date: 2014-12-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 2/Phase 3
• 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 or authorized representatives according to local rules or regulations

• Able to take liquid 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

• Chronically bed bound

• Patient, legal representative or patient's primary physician not committed to providing full, aggressive life support