Safety and Efficacy Study of Recombinant Human Lactoferrin to Treat Severe Sepsis - Full Text View

Purpose

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

Condition	Intervention	Phase
Severe Sepsis	Drug: Talactoferrin alfa Drug: Placebo	Phase II

MedlinePlus related topics:

Sepsis

Drug Information available for:

Talactoferrin Alfa Lactoferrin

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study

Official Title:	A Phase 2 Randomized, Double-Blind, Placebo-Controlled Study of the Safety and Efficacy of Talactoferrin Alfa in Patients With Severe Sepsis

Further study details as provided by Agennix:

Primary Outcome Measures:

All-cause mortality [ Time Frame: 28-day ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

All-cause mortality [ Time Frame: 3 months ] [ Designated as safety issue: No ]
All-cause mortality [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Estimated Enrollment:	190
Study Start Date:	April 2008
Estimated Study Completion Date:	December 2009
Estimated Primary Completion Date:	May 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: 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
2: Placebo Comparator Placebo	Drug: Placebo Placebo given 3 times a day for up to 28 days or until discharge from the intensive care unit

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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, legal next-of-kin or legal guardian
Able to take 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
Patient, legal representative or patient's primary physician not committed to providing full, aggressive life support

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00630656

Contacts


Contact: John P Schaumberg, Ph D	713-552-1091 ext 25	jschaumberg@agennix.com

Contact: Rajesh Malik, MD	713-552-1091 ext 38	rmalik@agennix.com

Locations


United States, California
	Olive View- UCLA Medical Center	Recruiting
	Sylmar, California, United States, 91342
	Loma Linda University Medical Center	Recruiting
	Loma Linda, California, United States, 92354
	UC Davis Medical Center	Recruiting
	Sacramento, California, United States, 95817

United States, Illinois
	West Suburban Medical Center	Recruiting
	Oak Park, Illinois, United States, 60302
	Rush University Medical Center	Recruiting
	Chicago, Illinois, United States, 60612

United States, Indiana
	Floyd Memorial Hospital and Health Services	Recruiting
	New Albany, Indiana, United States, 47105

United States, Iowa
	University of Iowa Hospitals and Clinic	Recruiting
	Iowa City, Iowa, United States, 52242

United States, Kansas
	University of Kansas Medical Center	Recruiting
	Kansas City, Kansas, United States, 66160

United States, Massachusetts
	Baystate Medical Center	Recruiting
	Springfield, Massachusetts, United States, 01199

United States, Michigan
	Henry Ford Health System	Recruiting
	Detroit, Michigan, United States, 48202

United States, Missouri
	St. John's Mercy Medical Center	Recruiting
	St. Louis, Missouri, United States, 63141

United States, New Jersey
	Cooper University Hospital	Recruiting
	Camden, New Jersey, United States, 08103

United States, North Carolina
	Duke University Medical Center	Recruiting
	Durham, North Carolina, United States, 27710
	Wake Forest University Baptist Medical Center	Recruiting
	Winston-Salem, North Carolina, United States, 27157

United States, Pennsylvania
	University of Pittsburgh Medical Center Presbyterian Hospital	Recruiting
	Pittsburgh, Pennsylvania, United States, 15213

United States, Rhode Island
	Rhode Island Hospital	Recruiting
	Providence, Rhode Island, United States, 02903

United States, Texas
	Texas Tech University Health Sciences Center	Recruiting
	El Paso, Texas, United States, 79905
	Ben Taub General Hospital	Recruiting
	Houston, Texas, United States, 77030
	Scott & White Memorial Hospital	Recruiting
	Temple, Texas, United States, 76508
	The Methodist Hospital	Recruiting
	Houston, Texas, United States, 77030

United States, Utah
	Intermountain Medical Center	Recruiting
	Salt Lake City, Utah, United States, 84143

Sponsors and Collaborators

Agennix

Investigators


Principal Investigator:	Kalpalatha K Guntupalli, MD	Baylor College of Medicine

More Information

Responsible Party:	Agennix ( Atul Varadhachary, President and Chief Operating Officer )
Study ID Numbers:	LF-0801, NIH grant 1R44GM077816-01A2
First Received:	February 28, 2008
Last Updated:	October 13, 2008
ClinicalTrials.gov Identifier:	NCT00630656
Health Authority:	United States: Food and Drug Administration

Keywords provided by Agennix:

sepsis

Study placed in the following topic categories:

Systemic Inflammatory Response Syndrome

Sepsis

Inflammation

Additional relevant MeSH terms:

Pathologic Processes

Infection

ClinicalTrials.gov processed this record on October 31, 2008

Sponsored by:	Agennix
Information provided by:	Agennix
ClinicalTrials.gov Identifier:	NCT00630656