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

February 2, 2012 updated by: Agennix

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.

Study Overview

Status

Suspended

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

1280

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
All Cause Mortality
Time Frame: 28 Days
28 Days

Secondary Outcome Measures

Outcome Measure
Time Frame
All Cause Mortality
Time Frame: 3 months
3 months
All Cause Mortality
Time Frame: 6 months
6 months
All Cause Mortality
Time Frame: 12 months
12 months
Assess Safety and Tolerability
Time Frame: 28 days
28 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Agennix

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2011

Primary Completion (Anticipated)

January 1, 2014

Study Completion (Anticipated)

December 1, 2014

Study Registration Dates

First Submitted

January 7, 2011

First Submitted That Met QC Criteria

January 10, 2011

First Posted (Estimate)

January 11, 2011

Study Record Updates

Last Update Posted (Estimate)

February 3, 2012

Last Update Submitted That Met QC Criteria

February 2, 2012

Last Verified

February 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LF-0802

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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