Safety and Efficacy of Talactoferrin Alfa in Patients With Severe Sepsis

Severe Sepsis Clinical Trial

— 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

Clinical Trial Details — Status: Suspended

Administrative data

• NCT number: NCT01273779
• Other study ID #: LF-0802
• 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

• Sepsis
• Severe Sepsis
• Toxemia

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