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

January 7, 2011
February 2, 2012
June 2011
January 2014   (final data collection date for primary outcome measure)
All Cause Mortality [ Time Frame: 28 Days ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01273779 on ClinicalTrials.gov Archive Site
  • 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 ]
  • All Cause Mortality [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • All Cause Mortality [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Safety and Efficacy of Talactoferrin Alfa in Patients With Severe Sepsis
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 will evaluate the safety and potential benefit of talactoferrin (recombinant human lactoferrin) as an addition to the standard care for severe sepsis.

Not Provided
Interventional
Phase 2
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Severe Sepsis
  • 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
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
  • Experimental: Talactoferrin alfa
    Intervention: Drug: Talactoferrin alfa
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Suspended
1280
December 2014
January 2014   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Belgium,   Canada,   Denmark,   France,   Germany,   Israel,   Netherlands,   Spain,   United Kingdom
 
NCT01273779
LF-0802
Yes
Agennix
Agennix
Not Provided
Not Provided
Agennix
February 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP