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Clinical Trial Details — Status: Suspended

Administrative data

NCT number NCT01273779
Other study ID # LF-0802
Secondary ID
Status Suspended
Phase Phase 2/Phase 3
First received January 7, 2011
Last updated February 2, 2012
Start date June 2011
Est. completion date December 2014

Study information

Verified date February 2012
Source Agennix
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

Study will evaluate the safety and potential benefit of talactoferrin (recombinant human lactoferrin) as an addition to the standard care for severe sepsis.


Recruitment information / eligibility

Status Suspended
Enrollment 1280
Est. completion date December 2014
Est. primary completion date January 2014
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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 Design

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


Related Conditions & MeSH terms


Intervention

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
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

Locations

Country Name City State
Belgium UZ Brussel Brussel
Belgium Cliniques Universitaires Saint-Luc Bruxelles
Belgium Hôpital Erasme Bruxelles
Belgium Hôpitaux IRIS Sud Bruxelles
Belgium Ziekenhuis Oost-Limburg Genk
Belgium UZ Gent Gent
Belgium CHU de Liège Liège
Belgium Centre Hospitalier de Dinant Mons
Belgium Clinique Saint-Pierre Ottignies
Belgium Cliniques Universitaires UCL de Mont-Godinne Yvoir
Canada Queen Elizabeth II Health Sciences Center Halifax Nova Scotia
Canada Kingston General Hospital Kingston Ontario
Canada SMBD - Jewish General Hospital Montreal Quebec
Canada Vancouver General Hospital Vancouver British Columbia
Canada Royal Jubilee Hospital Victoria British Columbia
Canada Windsor Regional Hospital Windsor Ontario
Canada Grace Hospital Winnipeg Manitoba
Canada Health Sciences Centre Winnipeg Manitoba
Canada St. Boniface General Hospital Winnipeg Manitoba
Denmark Aalborg Sygehus Aalborg
Denmark Odense universitetshospital Odense
France Hôtel Dieu Angers
France Centre Hospitalier Victor Dupouy Argenteuil
France Centre Hospitalier Départemental La Roche sur Yon, Luçon, Montaigu - Les Oudaries La Roche sur Yon
France Hôpital Albert Michallon / La Tronche La Tronche
France Hôpital Universitaire Dupuytren Limoges
France Centre Hospitalier de Montauban Montauban
France Hôpital de la Source Orléans
France Hôpital Cochin Paris
France Centre Hospitalier Lyon Sud Pierre Benite
France Hôpital de la Miletrie Poitiers
France Centre Hospitalier Angouleme Saint-Michel
France Hôpital Bretonneau Tours
Germany Charité - Universitätsmedizin Berlin Berlin
Germany Universitätsklinikum Bonn Bonn
Germany Helios Klinikum Erfurt Erfurt
Germany Klinikum der Johann-Wolfgang Goethe-Universität Frankfurt am Main
Germany Klinikum der Friedrich-Schiller-Universität Jena Jena
Germany Klinikum der Stadt Ludwigshafen gGmbH Ludwigshafen
Germany Klinikum Harlaching München
Israel Rambam Medical Center Haifa
Israel The Lady Davis Carmel Medical Center Haifa
Israel Hadassah University Hospital Ein Kerem Jerusalem
Israel Shaare Zedek Medical Center Jerusalem
Israel Western Galilee Hospital - Nahariya Nahariya
Israel Rabin Medical Center Petach Tikva
Netherlands Jeroen Bosch Ziekenhuis 's-Hertogenbosch
Netherlands VU Medisch Centrum Amsterdam
Netherlands Gelre Ziekenhuizen Apeldoorn
Netherlands Medisch Centrum Leeuwarden Leeuwarden
Netherlands UMC St. Radboud Nijmegen
Netherlands Ikazia Ziekenhuis Rotterdam
Spain Hospital del Mar Barcelona Cataluña
Spain Hospital Universitario de Getafe Getafe
Spain Hospital Universitari De Bellvitge L'Hospitalet de Llobregat Cataluña
Spain Hospital Clinico San Carlos Madrid Madrid, Communidad de
Spain Hospital Universitario La Paz Madrid Madrid, Communidad de
Spain Hospital Universitario La Paz Madrid
Spain Hospital de Sabadell Sabadell Cataluña
Spain Hospital Universitari de Tarragona Joan XXIII Tarragona Cataluña
Spain Hospital Mutua de Terrassa Terrassa Cataluña
United Kingdom Aberdeen Royal Infirmary Aberdeen
United Kingdom St James's University Hospital Leeds
United Kingdom St John's Hospital Livingston
United Kingdom St. Thomas' Hospital London
United Kingdom University College London London
United States University of Alabama - Birmingham Birmingham Alabama
United States Cooper University Hospital Camden New Jersey
United States Bay Area Chest Physicians Clearwater Florida
United States Riverside Methodist Hospital Columbus Ohio
United States Denver Health Medical Center Denver Colorado
United States Henry Ford Hospital Detroit Michigan
United States Texas Tech Health Science Center El Paso Texas
United States Moses Cone Memorial Hospital Greensboro North Carolina
United States Baylor College of Medicine Houston Texas
United States Eastern Idaho Medical Consultants Idaho Falls Idaho
United States Methodist Research Institute Indianapolis Indiana
United States University of Iowa Iowa City Iowa
United States University of Kansas Medical Center Kansas City Kansas
United States University of Wisconsin Medical School Madison Wisconsin
United States Maricopa Medical Center Maricopa Arizona
United States University of Tennessee Memphis Tennessee
United States Providence Hospital Mobile Alabama
United States LDS Hospital Murray Utah
United States Christiana Care Health Services Newark Delaware
United States West Suburban Hospital Medical Center Oak Park Illinois
United States University of Oklahoma Health Science Center Oklahoma Oklahoma
United States University of Nebraska Medical Center Omaha Nebraska
United States St. Joseph Hospital Orange California
United States Peoria Pulmonary Associates Peoria Illinois
United States Cancer Institute, Hillman Cancer Center Pittsburgh Pennsylvania
United States Rhode Island Hospital Providence Rhode Island
United States Sharp Memorial Hospital San Diego California
United States Baystate Medical Center Springfield Massachusetts
United States St. Johns Mercy Medical Center St. Louis Missouri
United States Stanford University Hospital Stanford California
United States UCLA Medical Center Sylmar California
United States St. Vincent Mercy Medical Center Toledo Ohio
United States George Washington University Hospital Washington District of Columbia
United States Wake Forest University Health Sciences Winston-Salem North Carolina

Sponsors (1)

Lead Sponsor Collaborator
Agennix

Countries where clinical trial is conducted

United States,  Belgium,  Canada,  Denmark,  France,  Germany,  Israel,  Netherlands,  Spain,  United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary All Cause Mortality 28 Days No
Secondary All Cause Mortality 3 months No
Secondary All Cause Mortality 6 months No
Secondary All Cause Mortality 12 months No
Secondary Assess Safety and Tolerability 28 days Yes
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