Safety and Efficacy of Talactoferrin Alfa in Patients With Severe Sepsis (OASIS)

Agennix

Status and phase: Suspended; Phase 3; Phase 2

Conditions: Severe Sepsis

Treatments: Drug: Talactoferrin alfa; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT01273779

LF-0802

Details and patient eligibility

About

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

Enrollment: 1,280 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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1,280 participants in 2 patient groups, including a placebo group

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo

Talactoferrin alfa

Experimental group

Treatment:

Drug: Talactoferrin alfa