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

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: NCT01273779
Recruitment Status : Suspended (Data Safety Monitoring Board recommendation)
First Posted : January 11, 2011
Last Update Posted : February 3, 2012
Sponsor:
Information provided by (Responsible Party):

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

Condition or disease Intervention/treatment Phase
Severe Sepsis Drug: Talactoferrin alfa Drug: Placebo Phase 2 Phase 3

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1280 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: OASIS: A Phase 2/3 Randomized, Double-blind, Placebo-controlled Study of the Safety and Efficacy of Talactoferrin Alfa in Patients With Severe Sepsis
Study Start Date : June 2011
Estimated Primary Completion Date : January 2014
Estimated Study Completion Date : December 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sepsis
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Placebo Comparator: Placebo Drug: Placebo
15 mL of oral solution of placebo given 3 times a day for up to 28 days or until discharge from the intensive care unit
Experimental: 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


Outcome Measures

Primary Outcome Measures :
  1. All Cause Mortality [ Time Frame: 28 Days ]

Secondary Outcome Measures :
  1. All Cause Mortality [ Time Frame: 3 months ]
  2. All Cause Mortality [ Time Frame: 6 months ]
  3. All Cause Mortality [ Time Frame: 12 months ]
  4. Assess Safety and Tolerability [ Time Frame: 28 days ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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 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
Contacts and Locations

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): NCT01273779


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Sponsors and Collaborators
Agennix
More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Agennix
ClinicalTrials.gov Identifier: NCT01273779     History of Changes
Other Study ID Numbers: LF-0802
First Posted: January 11, 2011    Key Record Dates
Last Update Posted: February 3, 2012
Last Verified: February 2012

Keywords provided by Agennix:
sepsis
talactoferrin
lactoferrin
recombinant human lactoferrin

Additional relevant MeSH terms:
Sepsis
Toxemia
Infection
Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes
Lactoferrin
Anti-Infective Agents