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

This study has suspended participant recruitment.
(Data Safety Monitoring Board recommendation)
Information provided by (Responsible Party):
Agennix Identifier:
First received: January 7, 2011
Last updated: February 2, 2012
Last verified: February 2012
Study will evaluate the safety and potential benefit of talactoferrin (recombinant human lactoferrin) as an addition to the standard care for severe sepsis.

Condition Intervention Phase
Severe Sepsis
Drug: Talactoferrin alfa
Drug: Placebo
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (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

Resource links provided by NLM:

Further study details as provided by Agennix:

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

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

Estimated Enrollment: 1280
Study Start Date: June 2011
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts 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 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01273779

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Sponsors and Collaborators
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Agennix Identifier: NCT01273779     History of Changes
Other Study ID Numbers: LF-0802
Study First Received: January 7, 2011
Last Updated: February 2, 2012

Keywords provided by Agennix:
recombinant human lactoferrin

Additional relevant MeSH terms:
Systemic Inflammatory Response Syndrome
Pathologic Processes
Anti-Infective Agents processed this record on May 25, 2017