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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00630656
Recruitment Status : Completed
First Posted : March 7, 2008
Last Update Posted : August 23, 2011
Sponsor:
Information provided by (Responsible Party):
Agennix

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

Condition or disease Intervention/treatment Phase
Severe Sepsis Drug: Talactoferrin alfa Drug: Placebo Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 190 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Phase 2 Randomized, Double-blind, Placebo-controlled Study of the Safety and Efficacy of Talactoferrin Alfa in Patients With Severe Sepsis
Study Start Date : April 2008
Actual Primary Completion Date : August 2009
Actual Study Completion Date : February 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sepsis

Arms and Interventions
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Arm Intervention/treatment
Experimental: 1
Talactoferrin alfa
 Drug: Talactoferrin alfa
15 mL of an oral solution of 100mg/mL (1.5 g) given 3 times a day for up to 28 days or until discharge from the intensive care unit
Placebo Comparator: 2
Placebo
 Drug: Placebo
Placebo given 3 times a day for up to 28 days or until discharge from the intensive care unit


Outcome Measures
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Primary Outcome Measures :
  1. All-cause mortality [ Time Frame: 28-day ]

Secondary Outcome Measures :
  1. All-cause mortality [ Time Frame: 3 months ]
  2. All-cause mortality [ Time Frame: 6 months ]

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00630656


Locations
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Sponsors and Collaborators
Agennix
Investigators
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Principal Investigator: Kalpalatha K Guntupalli, MD Baylor College of Medicine
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Agennix
ClinicalTrials.gov Identifier: NCT00630656    
Other Study ID Numbers: LF-0801
NIH grant 1R44GM077816-01A2
First Posted: March 7, 2008    Key Record Dates
Last Update Posted: August 23, 2011
Last Verified: August 2011
Keywords provided by Agennix:
sepsis
talactoferrin
lactoferrin
recombinant human lactoferrin
Additional relevant MeSH terms:
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Sepsis
Toxemia
Infections
Systemic Inflammatory Response Syndrome
 Inflammation
Pathologic Processes
Talactoferrin alfa
Antineoplastic Agents