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

Primary Purpose

Severe Sepsis

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Talactoferrin alfa
Placebo
Sponsored by
Agennix
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Severe Sepsis focused on measuring sepsis, talactoferrin, lactoferrin, recombinant human lactoferrin

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Loma Linda University Medical Center
  • UC Davis Medical Center
  • Olive View- UCLA Medical Center
  • Denver Health Medical Center
  • The George Washington University Hospital
  • Rush University Medical Center
  • West Suburban Medical Center
  • Floyd Memorial Hospital and Health Services
  • University of Iowa Hospitals and Clinic
  • University of Kansas Medical Center
  • Baystate Medical Center
  • Henry Ford Health System
  • St. Louis University
  • St. John's Mercy Medical Center
  • Cooper University Hospital
  • Duke University Medical Center
  • Wake Forest University Baptist Medical Center
  • Wake Forest University Health Sciences
  • University of Oklahoma Health Science Center
  • University of Pittsburgh Medical Center Presbyterian Hospital
  • Rhode Island Hospital
  • Texas Tech University Health Sciences Center
  • Ben Taub General Hospital
  • The Methodist Hospital
  • The University of Texas MD Anderson Cancer Center
  • Scott & White Memorial Hospital
  • Intermountain Medical Center
  • Vancouver General Hospital
  • Kingston General Hospital
  • Centre Hospitalier de Montauban
  • Centre Hospitalier Angouleme
  • Helios Klinikum Erfurt
  • Hospital de Sabadell
  • Hospital Mutua de Terrassa

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

1

2

Arm Description

Talactoferrin alfa

Placebo

Outcomes

Primary Outcome Measures

All-cause mortality

Secondary Outcome Measures

All-cause mortality
All-cause mortality

Full Information

First Posted
February 28, 2008
Last Updated
August 18, 2011
Sponsor
Agennix
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1. Study Identification

Unique Protocol Identification Number
NCT00630656
Brief Title
Safety and Efficacy Study of Recombinant Human Lactoferrin to Treat Severe Sepsis
Official Title
A Phase 2 Randomized, Double-blind, Placebo-controlled Study of the Safety and Efficacy of Talactoferrin Alfa in Patients With Severe Sepsis
Study Type
Interventional

2. Study Status

Record Verification Date
August 2011
Overall Recruitment Status
Completed
Study Start Date
April 2008 (undefined)
Primary Completion Date
August 2009 (Actual)
Study Completion Date
February 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Agennix

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Severe Sepsis
Keywords
sepsis, talactoferrin, lactoferrin, recombinant human lactoferrin

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
190 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
Talactoferrin alfa
Arm Title
2
Arm Type
Placebo Comparator
Arm Description
Placebo
Intervention Type
Drug
Intervention Name(s)
Talactoferrin alfa
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo given 3 times a day for up to 28 days or until discharge from the intensive care unit
Primary Outcome Measure Information:
Title
All-cause mortality
Time Frame
28-day
Secondary Outcome Measure Information:
Title
All-cause mortality
Time Frame
3 months
Title
All-cause mortality
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kalpalatha K Guntupalli, MD
Organizational Affiliation
Baylor College of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Loma Linda University Medical Center
City
Loma Linda
State/Province
California
ZIP/Postal Code
92354
Country
United States
Facility Name
UC Davis Medical Center
City
Sacramento
State/Province
California
ZIP/Postal Code
95817
Country
United States
Facility Name
Olive View- UCLA Medical Center
City
Sylmar
State/Province
California
ZIP/Postal Code
91342
Country
United States
Facility Name
Denver Health Medical Center
City
Denver
State/Province
Colorado
ZIP/Postal Code
80204
Country
United States
Facility Name
The George Washington University Hospital
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20037
Country
United States
Facility Name
Rush University Medical Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
West Suburban Medical Center
City
Oak Park
State/Province
Illinois
ZIP/Postal Code
60302
Country
United States
Facility Name
Floyd Memorial Hospital and Health Services
City
New Albany
State/Province
Indiana
ZIP/Postal Code
47105
Country
United States
Facility Name
University of Iowa Hospitals and Clinic
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242
Country
United States
Facility Name
University of Kansas Medical Center
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66160
Country
United States
Facility Name
Baystate Medical Center
City
Springfield
State/Province
Massachusetts
ZIP/Postal Code
01199
Country
United States
Facility Name
Henry Ford Health System
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
Facility Name
St. Louis University
City
St. Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
St. John's Mercy Medical Center
City
St. Louis
State/Province
Missouri
ZIP/Postal Code
63141
Country
United States
Facility Name
Cooper University Hospital
City
Camden
State/Province
New Jersey
ZIP/Postal Code
08103
Country
United States
Facility Name
Duke University Medical Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
Wake Forest University Baptist Medical Center
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157
Country
United States
Facility Name
Wake Forest University Health Sciences
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27517
Country
United States
Facility Name
University of Oklahoma Health Science Center
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73104
Country
United States
Facility Name
University of Pittsburgh Medical Center Presbyterian Hospital
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
Facility Name
Rhode Island Hospital
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02903
Country
United States
Facility Name
Texas Tech University Health Sciences Center
City
El Paso
State/Province
Texas
ZIP/Postal Code
79905
Country
United States
Facility Name
Ben Taub General Hospital
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
The Methodist Hospital
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
The University of Texas MD Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Scott & White Memorial Hospital
City
Temple
State/Province
Texas
ZIP/Postal Code
76508
Country
United States
Facility Name
Intermountain Medical Center
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84143
Country
United States
Facility Name
Vancouver General Hospital
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V5Z 1M9
Country
Canada
Facility Name
Kingston General Hospital
City
Kingston
State/Province
Ontario
ZIP/Postal Code
K7L 2V7
Country
Canada
Facility Name
Centre Hospitalier de Montauban
City
Montauban
ZIP/Postal Code
82013
Country
France
Facility Name
Centre Hospitalier Angouleme
City
Saint-Michel
ZIP/Postal Code
16470
Country
France
Facility Name
Helios Klinikum Erfurt
City
Erfurt
ZIP/Postal Code
99089
Country
Germany
Facility Name
Hospital de Sabadell
City
Sabadell
State/Province
Cataluña
ZIP/Postal Code
08208
Country
Spain
Facility Name
Hospital Mutua de Terrassa
City
Terrassa
State/Province
Cataluña
ZIP/Postal Code
08221
Country
Spain

12. IPD Sharing Statement

Citations:
PubMed Identifier
23425819
Citation
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. Erratum In: Crit Care Med. 2014 May;42(5):e390. multiple investigator names added.
Results Reference
derived

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

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