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

This study has suspended participant recruitment.

(Data Safety Monitoring Board recommendation)

Sponsor:

Information provided by (Responsible Party):

Agennix

ClinicalTrials.gov Identifier:

NCT01273779

First received: January 7, 2011

Last updated: February 2, 2012

Last verified: February 2012

History of Changes

Tracking Information
First Received Date ^ICMJE	January 7, 2011
Last Updated Date	February 2, 2012
Start Date ^ICMJE	June 2011
Estimated Primary Completion Date	January 2014 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: January 10, 2011)	All Cause Mortality [ Time Frame: 28 Days ] [ Designated as safety issue: No ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01273779 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: January 27, 2011)	All Cause Mortality [ Time Frame: 3 months ] [ Designated as safety issue: No ] All Cause Mortality [ Time Frame: 6 months ] [ Designated as safety issue: No ] All Cause Mortality [ Time Frame: 12 months ] [ Designated as safety issue: No ] Assess Safety and Tolerability [ Time Frame: 28 days ] [ Designated as safety issue: Yes ]
Original Secondary Outcome Measures ^ICMJE (submitted: January 10, 2011)	All Cause Mortality [ Time Frame: 3 months ] [ Designated as safety issue: No ] All Cause Mortality [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Safety and Efficacy of Talactoferrin Alfa in Patients With Severe Sepsis
Official Title ^ICMJE	OASIS: A Phase 2/3 Randomized, Double-blind, Placebo-controlled Study of the Safety and Efficacy of Talactoferrin Alfa in Patients With Severe Sepsis
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.
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Phase 2 Phase 3
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment
Condition ^ICMJE	Severe Sepsis
Intervention ^ICMJE	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 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
Study Arm (s)	Placebo Comparator: Placebo Intervention: Drug: Placebo Experimental: Talactoferrin alfa Intervention: Drug: Talactoferrin alfa
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Suspended
Estimated Enrollment ^ICMJE	1280
Estimated Completion Date	December 2014
Estimated Primary Completion Date	January 2014 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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
Gender	Both
Ages	18 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States, Belgium, Canada, Denmark, France, Germany, Israel, Netherlands, Spain, United Kingdom

Administrative Information
NCT Number ^ICMJE	NCT01273779
Other Study ID Numbers ^ICMJE	LF-0802
Has Data Monitoring Committee	Yes
Responsible Party	Agennix
Study Sponsor ^ICMJE	Agennix
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Agennix
Verification Date	February 2012
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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