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NCT00630656 Clinical Trial

Safety and Efficacy Study of Recombinant Human Lactoferrin to Treat Severe Sepsis

Severe Sepsis Clinical Trial

Official title:
A Phase 2 Randomized, Double-blind, Placebo-controlled Study of the Safety and Efficacy of Talactoferrin Alfa in Patients With Severe Sepsis

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00630656
Other study ID # LF-0801
Secondary ID NIH grant 1R44GM
Status Completed
Phase Phase 2
First received February 28, 2008
Last updated August 18, 2011
Start date April 2008
Est. completion date February 2010

Study information
Verified date August 2011
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 recombinant human talactoferrin as an addition to the standard care of severe sepsis.

Recruitment information / eligibility
Status Completed
Enrollment 190
Est. completion date February 2010
Est. primary completion date August 2009
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, 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

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
Placebo given 3 times a day for up to 28 days or until discharge from the intensive care unit

Locations
Country Name City State
Canada Kingston General Hospital Kingston Ontario
Canada Vancouver General Hospital Vancouver British Columbia
France Centre Hospitalier de Montauban Montauban
France Centre Hospitalier Angouleme Saint-Michel
Germany Helios Klinikum Erfurt Erfurt
Spain Hospital de Sabadell Sabadell Cataluña
Spain Hospital Mutua de Terrassa Terrassa Cataluña
United States Cooper University Hospital Camden New Jersey
United States Rush University Medical Center Chicago Illinois
United States Denver Health Medical Center Denver Colorado
United States Henry Ford Health System Detroit Michigan
United States Duke University Medical Center Durham North Carolina
United States Texas Tech University Health Sciences Center El Paso Texas
United States Ben Taub General Hospital Houston Texas
United States The Methodist Hospital Houston Texas
United States The University of Texas MD Anderson Cancer Center Houston Texas
United States University of Iowa Hospitals and Clinic Iowa City Iowa
United States University of Kansas Medical Center Kansas City Kansas
United States Loma Linda University Medical Center Loma Linda California
United States Floyd Memorial Hospital and Health Services New Albany Indiana
United States West Suburban Medical Center Oak Park Illinois
United States University of Oklahoma Health Science Center Oklahoma City Oklahoma
United States University of Pittsburgh Medical Center Presbyterian Hospital Pittsburgh Pennsylvania
United States Rhode Island Hospital Providence Rhode Island
United States UC Davis Medical Center Sacramento California
United States Intermountain Medical Center Salt Lake City Utah
United States Baystate Medical Center Springfield Massachusetts
United States St. John's Mercy Medical Center St. Louis Missouri
United States St. Louis University St. Louis Missouri
United States Olive View- UCLA Medical Center Sylmar California
United States Scott & White Memorial Hospital Temple Texas
United States The George Washington University Hospital Washington District of Columbia
United States Wake Forest University Baptist Medical Center Winston-Salem North Carolina
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,  Canada,  France,  Germany,  Spain, 

Outcome
Type Measure Description Time frame Safety issue
Primary All-cause mortality 28-day No
Secondary All-cause mortality 3 months No
Secondary All-cause mortality 6 months No
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