Safety and Efficacy Study of Recombinant Human Lactoferrin to Treat Severe Sepsis
A Phase 2 Randomized, Double-blind, Placebo-controlled Study of the Safety and Efficacy of Talactoferrin Alfa in Patients With Severe Sepsis
2 other identifiers
interventional
190
5 countries
34
Brief Summary
Study will evaluate the safety and potential benefit of recombinant human talactoferrin as an addition to the standard care of severe sepsis.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Apr 2008
34 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 28, 2008
CompletedFirst Posted
Study publicly available on registry
March 7, 2008
CompletedStudy Start
First participant enrolled
April 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2010
CompletedAugust 23, 2011
August 1, 2011
1.3 years
February 28, 2008
August 18, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
All-cause mortality
28-day
Secondary Outcomes (2)
All-cause mortality
3 months
All-cause mortality
6 months
Study Arms (2)
1
EXPERIMENTALTalactoferrin alfa
2
PLACEBO COMPARATORPlacebo
Interventions
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 given 3 times a day for up to 28 days or until discharge from the intensive care unit
Eligibility Criteria
You may qualify if:
- 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, legal next-of-kin or legal guardian
- Able to take medication by mouth or feeding tube
You may not qualify if:
- 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
- Patient, legal representative or patient's primary physician not committed to providing full, aggressive life support
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Agennixlead
Study Sites (34)
Loma Linda University Medical Center
Loma Linda, California, 92354, United States
UC Davis Medical Center
Sacramento, California, 95817, United States
Olive View- UCLA Medical Center
Sylmar, California, 91342, United States
Denver Health Medical Center
Denver, Colorado, 80204, United States
The George Washington University Hospital
Washington D.C., District of Columbia, 20037, United States
Rush University Medical Center
Chicago, Illinois, 60612, United States
West Suburban Medical Center
Oak Park, Illinois, 60302, United States
Floyd Memorial Hospital and Health Services
New Albany, Indiana, 47105, United States
University of Iowa Hospitals and Clinic
Iowa City, Iowa, 52242, United States
University of Kansas Medical Center
Kansas City, Kansas, 66160, United States
Baystate Medical Center
Springfield, Massachusetts, 01199, United States
Henry Ford Health System
Detroit, Michigan, 48202, United States
St. Louis University
St Louis, Missouri, 63110, United States
St. John's Mercy Medical Center
St Louis, Missouri, 63141, United States
Cooper University Hospital
Camden, New Jersey, 08103, United States
Duke University Medical Center
Durham, North Carolina, 27710, United States
Wake Forest University Baptist Medical Center
Winston-Salem, North Carolina, 27157, United States
Wake Forest University Health Sciences
Winston-Salem, North Carolina, 27517, United States
University of Oklahoma Health Science Center
Oklahoma City, Oklahoma, 73104, United States
University of Pittsburgh Medical Center Presbyterian Hospital
Pittsburgh, Pennsylvania, 15213, United States
Rhode Island Hospital
Providence, Rhode Island, 02903, United States
Texas Tech University Health Sciences Center
El Paso, Texas, 79905, United States
Ben Taub General Hospital
Houston, Texas, 77030, United States
The Methodist Hospital
Houston, Texas, 77030, United States
The University of Texas MD Anderson Cancer Center
Houston, Texas, 77030, United States
Scott & White Memorial Hospital
Temple, Texas, 76508, United States
Intermountain Medical Center
Salt Lake City, Utah, 84143, United States
Vancouver General Hospital
Vancouver, British Columbia, V5Z 1M9, Canada
Kingston General Hospital
Kingston, Ontario, K7L 2V7, Canada
Centre Hospitalier de Montauban
Montauban, 82013, France
Centre Hospitalier Angouleme
Saint-Michel, 16470, France
Helios Klinikum Erfurt
Erfurt, 99089, Germany
Hospital de Sabadell
Sabadell, Catalonia, 08208, Spain
Hospital Mutua de Terrassa
Terrassa, Catalonia, 08221, Spain
Related Publications (1)
Guntupalli K, Dean N, Morris PE, Bandi V, Margolis B, Rivers E, Levy M, Lodato RF, Ismail PM, Reese A, Schaumberg JP, Malik R, Dellinger RP; TLF LF-0801 Investigator Group. A phase 2 randomized, double-blind, placebo-controlled study of the safety and efficacy of talactoferrin in patients with severe sepsis. Crit Care Med. 2013 Mar;41(3):706-16. doi: 10.1097/CCM.0b013e3182741551.
PMID: 23425819DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Kalpalatha K Guntupalli, MD
Baylor College of Medicine
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 28, 2008
First Posted
March 7, 2008
Study Start
April 1, 2008
Primary Completion
August 1, 2009
Study Completion
February 1, 2010
Last Updated
August 23, 2011
Record last verified: 2011-08