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COMPLETEDPhase 2NCT00630656

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

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

Lead sponsor: Agennix•27 U.S. locations•View source on ClinicalTrials.gov

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Sponsors

Lead Sponsor

Agennix

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

No

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

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Data from ClinicalTrials.govLast updated on ClinicalTrials.gov: August 23, 2011Terms

Trial snapshot

StatusCOMPLETED

PhasePHASE2

Enrollment190

Start dateApr 2008

Last updatedAug 23, 2011

Condition

Locations shown

Loma Linda University Medical Center

Loma Linda, California

UC Davis Medical Center

Sacramento, California

Olive View- UCLA Medical Center

Sylmar, California

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: August 23, 2011Data synced to Clareo: May 25, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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