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

Primary Purpose

Severe Sepsis

Status
Suspended
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Talactoferrin alfa
Placebo
Sponsored by
Agennix
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Severe Sepsis focused on measuring sepsis, talactoferrin, lactoferrin, recombinant human lactoferrin

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Alabama - Birmingham
  • Providence Hospital
  • Maricopa Medical Center
  • St. Joseph Hospital
  • Sharp Memorial Hospital
  • Stanford University Hospital
  • UCLA Medical Center
  • Denver Health Medical Center
  • Christiana Care Health Services
  • George Washington University Hospital
  • Bay Area Chest Physicians
  • Eastern Idaho Medical Consultants
  • West Suburban Hospital Medical Center
  • Peoria Pulmonary Associates
  • Methodist Research Institute
  • University of Iowa
  • University of Kansas Medical Center
  • Baystate Medical Center
  • Henry Ford Hospital
  • St. Johns Mercy Medical Center
  • University of Nebraska Medical Center
  • Cooper University Hospital
  • Moses Cone Memorial Hospital
  • Wake Forest University Health Sciences
  • Riverside Methodist Hospital
  • St. Vincent Mercy Medical Center
  • University of Oklahoma Health Science Center
  • Cancer Institute, Hillman Cancer Center
  • Rhode Island Hospital
  • University of Tennessee
  • Texas Tech Health Science Center
  • Baylor College of Medicine
  • LDS Hospital
  • University of Wisconsin Medical School
  • UZ Brussel
  • Hôpitaux IRIS Sud
  • Hôpital Erasme
  • Cliniques Universitaires Saint-Luc
  • Ziekenhuis Oost-Limburg
  • UZ Gent
  • CHU de Liège
  • Centre Hospitalier de Dinant
  • Clinique Saint-Pierre
  • Cliniques Universitaires UCL de Mont-Godinne
  • Vancouver General Hospital
  • Royal Jubilee Hospital
  • St. Boniface General Hospital
  • Health Sciences Centre
  • Grace Hospital
  • Queen Elizabeth II Health Sciences Center
  • Kingston General Hospital
  • Windsor Regional Hospital
  • SMBD - Jewish General Hospital
  • Aalborg Sygehus
  • Odense universitetshospital
  • Hôtel Dieu
  • Centre Hospitalier Victor Dupouy
  • Centre Hospitalier Départemental La Roche sur Yon, Luçon, Montaigu - Les Oudaries
  • Hôpital Albert Michallon / La Tronche
  • Hôpital Universitaire Dupuytren
  • Centre Hospitalier de Montauban
  • Hôpital de la Source
  • Hôpital Cochin
  • Centre Hospitalier Lyon Sud
  • Hôpital de la Miletrie
  • Centre Hospitalier Angouleme
  • Hôpital Bretonneau
  • Charité - Universitätsmedizin Berlin
  • Universitätsklinikum Bonn
  • Helios Klinikum Erfurt
  • Klinikum der Johann-Wolfgang Goethe-Universität
  • Klinikum der Friedrich-Schiller-Universität Jena
  • Klinikum der Stadt Ludwigshafen gGmbH
  • Klinikum Harlaching
  • Rambam Medical Center
  • The Lady Davis Carmel Medical Center
  • Shaare Zedek Medical Center
  • Hadassah University Hospital Ein Kerem
  • Western Galilee Hospital - Nahariya
  • Rabin Medical Center
  • Jeroen Bosch Ziekenhuis
  • VU Medisch Centrum
  • Gelre Ziekenhuizen
  • Medisch Centrum Leeuwarden
  • UMC St. Radboud
  • Ikazia Ziekenhuis
  • Hospital del Mar
  • Hospital Universitari De Bellvitge
  • Hospital de Sabadell
  • Hospital Universitari de Tarragona Joan XXIII
  • Hospital Mutua de Terrassa
  • Hospital Clinico San Carlos
  • Hospital Universitario La Paz
  • Hospital Universitario de Getafe
  • Hospital Universitario La Paz
  • Aberdeen Royal Infirmary
  • St James's University Hospital
  • St John's Hospital
  • University College London
  • St. Thomas' Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Placebo

Talactoferrin alfa

Arm Description

Outcomes

Primary Outcome Measures

All Cause Mortality

Secondary Outcome Measures

All Cause Mortality
All Cause Mortality
All Cause Mortality
Assess Safety and Tolerability

Full Information

First Posted
January 7, 2011
Last Updated
February 2, 2012
Sponsor
Agennix
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1. Study Identification

Unique Protocol Identification Number
NCT01273779
Brief Title
Safety and Efficacy of Talactoferrin Alfa in Patients With Severe Sepsis
Acronym
OASIS
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
Study Type
Interventional

2. Study Status

Record Verification Date
February 2012
Overall Recruitment Status
Suspended
Why Stopped
Data Safety Monitoring Board recommendation
Study Start Date
June 2011 (undefined)
Primary Completion Date
January 2014 (Anticipated)
Study Completion Date
December 2014 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Agennix

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Severe Sepsis
Keywords
sepsis, talactoferrin, lactoferrin, recombinant human lactoferrin

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
1280 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Title
Talactoferrin alfa
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Talactoferrin alfa
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
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
Primary Outcome Measure Information:
Title
All Cause Mortality
Time Frame
28 Days
Secondary Outcome Measure Information:
Title
All Cause Mortality
Time Frame
3 months
Title
All Cause Mortality
Time Frame
6 months
Title
All Cause Mortality
Time Frame
12 months
Title
Assess Safety and Tolerability
Time Frame
28 days

10. Eligibility

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

12. IPD Sharing Statement

Citations:
PubMed Identifier
26010687
Citation
Vincent JL, Marshall JC, Dellinger RP, Simonson SG, Guntupalli K, Levy MM, Singer M, Malik R; Oral tAlactoferrin in Severe sepsIS Study Investigators. Talactoferrin in Severe Sepsis: Results From the Phase II/III Oral tAlactoferrin in Severe sepsIS Trial. Crit Care Med. 2015 Sep;43(9):1832-8. doi: 10.1097/CCM.0000000000001090.
Results Reference
derived

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Safety and Efficacy of Talactoferrin Alfa in Patients With Severe Sepsis

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