A Phase 2 Randomized, Double-blind, Placebo-controlled Study of the Safety and Efficacy of Talactoferrin Alfa in Patients With Severe Sepsis
Phase 2
18 Years
N/A
18 Years
N/A
Not Enrolling
Both
Severe Sepsis
Both
Severe Sepsis
Trial Information
A Phase 2 Randomized, Double-blind, Placebo-controlled Study of the Safety and Efficacy of Talactoferrin Alfa in Patients With Severe Sepsis
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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Outcome Measure:
All-cause mortality
Outcome Time Frame:
28-day
Safety Issue:
No
Principal Investigator
Kalpalatha K Guntupalli, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Baylor College of Medicine
Authority:
United States: Food and Drug Administration
Study ID:
LF-0801
NCT ID:
NCT00630656
Start Date:
April 2008
Completion Date:
February 2010
Related Keywords:
- Severe Sepsis
- sepsis
- talactoferrin
- lactoferrin
- recombinant human lactoferrin
- Sepsis
- Toxemia
Name | Location |
|---|---|
| Rhode Island Hospital | Providence, Rhode Island 02903 |
| Loma Linda University Medical Center | Loma Linda, California 92354 |
| Rush University Medical Center | Chicago, Illinois 60612-3824 |
| University of Kansas Medical Center | Kansas City, Kansas 66160-7353 |
| Baystate Medical Center | Springfield, Massachusetts 01199 |
| Cooper University Hospital | Camden, New Jersey 08103 |
| Denver Health Medical Center | Denver, Colorado 80204-4507 |
| St. John's Mercy Medical Center | Saint Louis, Missouri 63141 |
| Ben Taub General Hospital | Houston, Texas 77030 |
| Duke University Medical Center | Durham, North Carolina 27710 |
| Henry Ford Health System | Detroit, Michigan 48202 |
| Scott & White Memorial Hospital | Temple,, Texas 76508 |
| The Methodist Hospital | Houston, Texas 77030 |
| St. Louis University | St. Louis, Missouri 63110 |
| Wake Forest University Health Sciences | Winston-Salem, North Carolina 27157 |
| University of Oklahoma Health Science Center | Oklahoma City, Oklahoma 73104 |
| The University of Texas MD Anderson Cancer Center | Houston, Texas 77030-4009 |
| Wake Forest University Baptist Medical Center | Winston-Salem, North Carolina 27157 |
| UC Davis Medical Center | Sacramento, California 95817 |
| Intermountain Medical Center | Murray, Utah 84157 |
| Texas Tech University Health Sciences Center | Lubbock, Texas 79430 |
| Olive View- UCLA Medical Center | Sylmar, California 91342 |
| The George Washington University Hospital | Washington, District of Columbia 20037 |
| West Suburban Medical Center | Oak Park, Illinois 60302 |
| Floyd Memorial Hospital and Health Services | New Albany, Indiana 47105 |
| University of Iowa Hospitals and Clinic | Iowa City, Iowa 52242 |
| University of Pittsburgh Medical Center Presbyterian Hospital | Pittsburgh, Pennsylvania 15213 |
