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

Status

Indicates the current recruitment status or the expanded access status.
Suspended

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1280

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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 Liege
      • 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
        • Hopital Universitaire Dupuytren
      • Montauban, France, 82013
        • Centre Hospitalier de Montauban
      • Orléans, France, 45067
        • Hôpital de la Source
      • Paris, France, 75679
        • Hopital Cochin
      • Pierre Benite, France, 69495
        • Centre Hospitalier Lyon Sud
      • Poitiers, France, 86021
        • Hopital de la Milétrie
      • Saint-Michel, France, 16470
        • Centre Hospitalier Angoulême
      • Tours, France, 37044
        • Hôpital Bretonneau
  • Germany
      • Berlin, Germany, 13353
        • Charité - Universitätsmedizin 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
All Cause Mortality
Time Frame: 28 Days
28 Days

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2011

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 1, 2014

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2014

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 7, 2011

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 10, 2011

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 11, 2011

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 3, 2012

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 2, 2012

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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