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

Phase 2

Completed

• Conditions: Severe Sepsis
• Interventions: Drug: Placebo; Drug: Talactoferrin alfa

• Registration Number: NCT00630656
• Lead Sponsor: Agennix

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2008-02-28
• Study First Submitted QC: 2008-02-28
• Study First Posted: 2008-03-07
• Study Start: 2008-04
• Primary Completion: 2009-08
• Study Completion: 2010-02
• Status Verified: 2011-08
• Disposition First Submitted: 2011-08-11
• Disposition First Submitted QC: 2011-08-11
• Disposition First Posted: 2011-08-15
• Last Update Submitted: 2011-08-18
• Last Update Posted: 2011-08-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 190

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2	Placebo	Placebo
1	Talactoferrin alfa	Talactoferrin alfa

Primary Outcome Measures

Name	Time	Method
All-cause mortality	28-day

Secondary Outcome Measures

Name	Time	Method
All-cause mortality	6 months

Trial Locations

Locations (34)

Loma Linda University Medical Center; 🇺🇸 Loma Linda, California, United States

UC Davis Medical Center; 🇺🇸 Sacramento, California, United States

Olive View- UCLA Medical Center; 🇺🇸 Sylmar, California, United States

Denver Health Medical Center; 🇺🇸 Denver, Colorado, United States

The George Washington University Hospital; 🇺🇸 Washington, District of Columbia, United States

Rush University Medical Center; 🇺🇸 Chicago, Illinois, United States

West Suburban Medical Center; 🇺🇸 Oak Park, Illinois, United States

Floyd Memorial Hospital and Health Services; 🇺🇸 New Albany, Indiana, United States

University of Iowa Hospitals and Clinic; 🇺🇸 Iowa City, Iowa, United States

University of Kansas Medical Center; 🇺🇸 Kansas City, Kansas, United States

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