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
  Purpose

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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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 ClinicalTrials.gov identifier: NCT01273779

  Hide Study Locations
Locations
United States, Alabama
University of Alabama - Birmingham
Birmingham, Alabama, United States, 35249
Providence Hospital
Mobile, Alabama, United States, 36608
United States, Arizona
Maricopa Medical Center
Maricopa, Arizona, United States, 85008
United States, California
St. Joseph Hospital
Orange, California, United States, 92868
Sharp Memorial Hospital
San Diego, California, United States, 92123
Stanford University Hospital
Stanford, California, United States, 94305-5117
UCLA Medical Center
Sylmar, California, United States, 91342
United States, Colorado
Denver Health Medical Center
Denver, Colorado, United States, 80204
United States, Delaware
Christiana Care Health Services
Newark, Delaware, United States, 19718
United States, District of Columbia
George Washington University Hospital
Washington, District of Columbia, United States, 20037
United States, Florida
Bay Area Chest Physicians
Clearwater, Florida, United States, 33756
United States, Idaho
Eastern Idaho Medical Consultants
Idaho Falls, Idaho, United States, 83404
United States, Illinois
West Suburban Hospital Medical Center
Oak Park, Illinois, United States, 60302
Peoria Pulmonary Associates
Peoria, Illinois, United States, 61603
United States, Indiana
Methodist Research Institute
Indianapolis, Indiana, United States, 46202
United States, Iowa
University of Iowa
Iowa City, Iowa, United States, 52242
United States, Kansas
University of Kansas Medical Center
Kansas City, Kansas, United States, 66160
United States, Massachusetts
Baystate Medical Center
Springfield, Massachusetts, United States, 01199
United States, Michigan
Henry Ford Hospital
Detroit, Michigan, United States, 48202
United States, Missouri
St. Johns Mercy Medical Center
St. Louis, Missouri, United States, 63141
United States, Nebraska
University of Nebraska Medical Center
Omaha, Nebraska, United States, 68198
United States, New Jersey
Cooper University Hospital
Camden, New Jersey, United States, 08103
United States, North Carolina
Moses Cone Memorial Hospital
Greensboro, North Carolina, United States, 27401
Wake Forest University Health Sciences
Winston-Salem, North Carolina, United States, 27517
United States, Ohio
Riverside Methodist Hospital
Columbus, Ohio, United States, 43214
St. Vincent Mercy Medical Center
Toledo, Ohio, United States, 43608
United States, Oklahoma
University of Oklahoma Health Science Center
Oklahoma, Oklahoma, United States, 73104
United States, Pennsylvania
Cancer Institute, Hillman Cancer Center
Pittsburgh, Pennsylvania, United States, 15232
United States, Rhode Island
Rhode Island Hospital
Providence, Rhode Island, United States, 02903
United States, Tennessee
University of Tennessee
Memphis, Tennessee, United States, 38163
United States, Texas
Texas Tech Health Science Center
El Paso, Texas, United States, 79905
Baylor College of Medicine
Houston, Texas, United States, 77030
United States, Utah
LDS Hospital
Murray, Utah, United States, 84157
United States, Wisconsin
University of Wisconsin Medical School
Madison, Wisconsin, United States, 53792
Belgium
UZ Brussel
Brussel, Belgium, 1090
Cliniques Universitaires Saint-Luc
Bruxelles, Belgium, 1200
Hôpital Erasme
Bruxelles, Belgium, 1070
Hôpitaux IRIS Sud
Bruxelles, Belgium, 1050
Ziekenhuis Oost-Limburg
Genk, Belgium, 3600
UZ Gent
Gent, Belgium, 9000
CHU de Liège
Liège, Belgium, 4000
Centre Hospitalier de Dinant
Mons, Belgium, 7000
Clinique Saint-Pierre
Ottignies, Belgium, 1340
Cliniques Universitaires UCL de Mont-Godinne
Yvoir, Belgium, 5530
Canada, British Columbia
Vancouver General Hospital
Vancouver, British Columbia, Canada, V5Z 1M9
Royal Jubilee Hospital
Victoria, British Columbia, Canada, V8R 1J8
Canada, Manitoba
Grace Hospital
Winnipeg, Manitoba, Canada, R3J 3M7
St. Boniface General Hospital
Winnipeg, Manitoba, Canada, R2H 2A6
Health Sciences Centre
Winnipeg, Manitoba, Canada, R3A 1R9
Canada, Nova Scotia
Queen Elizabeth II Health Sciences Center
Halifax, Nova Scotia, Canada, B3H 3A7
Canada, Ontario
Kingston General Hospital
Kingston, Ontario, Canada, K7L 2V7
Windsor Regional Hospital
Windsor, Ontario, Canada, N8X 3V6
Canada, Quebec
SMBD - Jewish General Hospital
Montreal, Quebec, Canada, H3T 1C5
Denmark
Aalborg Sygehus
Aalborg, Denmark, DK-9100
Odense universitetshospital
Odense, Denmark, DK-5000
France
Hôtel Dieu
Angers, France, 49933
Centre Hospitalier Victor Dupouy
Argenteuil, France, 95107
Centre Hospitalier Départemental La Roche sur Yon, Luçon, Montaigu - Les Oudaries
La Roche sur Yon, France, 85925
Hôpital Albert Michallon / La Tronche
La Tronche, France, 38700
Hôpital Universitaire Dupuytren
Limoges, France, 87042
Centre Hospitalier de Montauban
Montauban, France, 82013
Hôpital de la Source
Orléans, France, 45067
Hôpital Cochin
Paris, France, 75679
Centre Hospitalier Lyon Sud
Pierre Benite, France, 69495
Hôpital de la Miletrie
Poitiers, France, 86021
Centre Hospitalier Angouleme
Saint-Michel, France, 16470
Hôpital Bretonneau
Tours, France, 37044
Germany
Charité - Universitätsmedizin Berlin
Berlin, Germany, 13353
Universitätsklinikum Bonn
Bonn, Germany, 53105
Helios Klinikum Erfurt
Erfurt, Germany, 99089
Klinikum der Johann-Wolfgang Goethe-Universität
Frankfurt am Main, Germany, 60590
Klinikum der Friedrich-Schiller-Universität Jena
Jena, Germany, 07747
Klinikum der Stadt Ludwigshafen gGmbH
Ludwigshafen, Germany, 67063
Klinikum Harlaching
München, Germany, 81545
Israel
The Lady Davis Carmel Medical Center
Haifa, Israel, 34362
Rambam Medical Center
Haifa, Israel, 31096
Hadassah University Hospital Ein Kerem
Jerusalem, Israel, 91120
Shaare Zedek Medical Center
Jerusalem, Israel, 91031
Western Galilee Hospital - Nahariya
Nahariya, Israel, 22100
Rabin Medical Center
Petach Tikva, Israel, 49100
Netherlands
Jeroen Bosch Ziekenhuis
's-Hertogenbosch, Netherlands, 5223 GZ
VU Medisch Centrum
Amsterdam, Netherlands, 1081 HV
Gelre Ziekenhuizen
Apeldoorn, Netherlands, 7334 DZ
Medisch Centrum Leeuwarden
Leeuwarden, Netherlands, 8934 AD
UMC St. Radboud
Nijmegen, Netherlands, 6525 GA
Ikazia Ziekenhuis
Rotterdam, Netherlands, 3083 AN
Spain
Hospital del Mar
Barcelona, Cataluña, Spain, 08003
Hospital Universitari De Bellvitge
L'Hospitalet de Llobregat, Cataluña, Spain, 08907
Hospital de Sabadell
Sabadell, Cataluña, Spain, 8208
Hospital Universitari de Tarragona Joan XXIII
Tarragona, Cataluña, Spain, 43007
Hospital Mutua de Terrassa
Terrassa, Cataluña, Spain, 08221
Hospital Universitario La Paz
Madrid, Madrid, Communidad de, Spain, 28046
Hospital Clinico San Carlos
Madrid, Madrid, Communidad de, Spain, 28040
Hospital Universitario de Getafe
Getafe, Spain, 28905
Hospital Universitario La Paz
Madrid, Spain, 28046
United Kingdom
Aberdeen Royal Infirmary
Aberdeen, United Kingdom, AB25 2ZN
St James's University Hospital
Leeds, United Kingdom, LS9 7TF
St John's Hospital
Livingston, United Kingdom, EH54 6PP
St. Thomas' Hospital
London, United Kingdom, SE1 7EH
University College London
London, United Kingdom, NW1 2BU
Sponsors and Collaborators
Agennix
  More Information

No publications provided

Responsible Party: Agennix
ClinicalTrials.gov Identifier: NCT01273779     History of Changes
Other Study ID Numbers: LF-0802
Study First Received: January 7, 2011
Last Updated: February 2, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Agennix:
sepsis
talactoferrin
lactoferrin
recombinant human lactoferrin

Additional relevant MeSH terms:
Sepsis
Toxemia
Infection
Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes

ClinicalTrials.gov processed this record on August 01, 2014