Know Cancer

forgot password

OASIS: A Phase 2/3 Randomized, Double-blind, Placebo-controlled Study of the Safety and Efficacy of Talactoferrin Alfa in Patients With Severe Sepsis

Phase 2/Phase 3
18 Years
Not Enrolling
Severe Sepsis

Thank you

Trial Information

OASIS: A Phase 2/3 Randomized, Double-blind, Placebo-controlled Study of the Safety and Efficacy of Talactoferrin Alfa in Patients With Severe Sepsis

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

- 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

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Outcome Measure:

All Cause Mortality

Outcome Time Frame:

28 Days

Safety Issue:



United States: Food and Drug Administration

Study ID:




Start Date:

June 2011

Completion Date:

December 2014

Related Keywords:

  • Severe Sepsis
  • sepsis
  • talactoferrin
  • lactoferrin
  • recombinant human lactoferrin
  • Sepsis
  • Toxemia



Baylor College of Medicine Houston, Texas  77030
University of Iowa Iowa City, Iowa  52242
Rhode Island Hospital Providence, Rhode Island  02903
Henry Ford Hospital Detroit, Michigan  48202
LDS Hospital Salt Lake City, Utah  84143
University of Kansas Medical Center Kansas City, Kansas  66160-7353
West Suburban Hospital Medical Center Oak Park, Illinois  60302
Baystate Medical Center Springfield, Massachusetts  01199
University of Nebraska Medical Center Omaha, Nebraska  68198-3330
Cooper University Hospital Camden, New Jersey  08103
St. Vincent Mercy Medical Center Toledo, Ohio  43608
George Washington University Hospital Washington, District of Columbia  20037
Denver Health Medical Center Denver, Colorado  80204-4507
Sharp Memorial Hospital San Diego, California  92123
Providence Hospital Mobile, Alabama  36608
UCLA Medical Center Los Angeles, California  90095-7059
Riverside Methodist Hospital Columbus, Ohio  43214
St. Johns Mercy Medical Center St. Louis, Missouri  63141
Wake Forest University Health Sciences Winston-Salem, North Carolina  27157
University of Wisconsin Medical School Madison, Wisconsin  53792-0001
University of Oklahoma Health Science Center Oklahoma City, Oklahoma  73104
Christiana Care Health Services Newark, Delaware  19713
University of Tennessee Memphis, Tennessee  38163
Stanford University Hospital Stanford, California  94303
St. Joseph Hospital Orange, California  92868
Bay Area Chest Physicians Clearwater, Florida  33756
University of Alabama - Birmingham Birmingham, Alabama  35294
Maricopa Medical Center Phoenix, Arizona  85008
Eastern Idaho Medical Consultants Idaho Falls, Idaho  83404
Peoria Pulmonary Associates Peoria, Illinois  61603
Methodist Research Institute Indianapolis, Indiana  46202
Moses Cone Memorial Hospital Greensboro, North Carolina  27401
Cancer Institute, Hillman Cancer Center Pittsburgh, Pennsylvania  15232
Texas Tech Health Science Center El Paso, Texas  79905