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

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

Study Overview

• Status: Completed
• Conditions: Severe Sepsis
• Intervention / Treatment: Drug: Talactoferrin alfa; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 190
• Phase: Phase 2

Contacts and Locations

Study Locations

• Canada
  • British Columbia
    • Vancouver, British Columbia, Canada, V5Z 1M9
      • Vancouver General Hospital
  • Ontario
    • Kingston, Ontario, Canada, K7L 2V7
      • Kingston General Hospital
• France
  • Montauban, France, 82013
    • Centre Hospitalier de Montauban
  • Saint-Michel, France, 16470
    • Centre Hospitalier Angoulême
• Germany
  • Erfurt, Germany, 99089
    • Helios Klinikum Erfurt
• Spain
  • Cataluña
    • Sabadell, Cataluña, Spain, 08208
      • Hospital de Sabadell
    • Terrassa, Cataluña, Spain, 08221
      • Hospital Mutua De Terrassa
• United States
  • California
    • Loma Linda, California, United States, 92354
      • Loma Linda University Medical Center
    • Sacramento, California, United States, 95817
      • UC Davis Medical Center
    • Sylmar, California, United States, 91342
      • Olive View- UCLA Medical Center
  • Colorado
    • Denver, Colorado, United States, 80204
      • Denver Health Medical Center
  • District of Columbia
    • Washington, District of Columbia, United States, 20037
      • The George Washington University Hospital
  • Illinois
    • Chicago, Illinois, United States, 60612
      • Rush University Medical Center
    • Oak Park, Illinois, United States, 60302
      • West Suburban Medical Center
  • Indiana
    • New Albany, Indiana, United States, 47105
      • Floyd Memorial Hospital and Health Services
  • Iowa
    • Iowa City, Iowa, United States, 52242
      • University of Iowa Hospitals and Clinic
  • Kansas
    • Kansas City, Kansas, United States, 66160
      • University of Kansas Medical Center
  • Massachusetts
    • Springfield, Massachusetts, United States, 01199
      • Baystate Medical Center
  • Michigan
    • Detroit, Michigan, United States, 48202
      • Henry Ford Health System
  • Missouri
    • St. Louis, Missouri, United States, 63110
      • St. Louis University
    • St. Louis, Missouri, United States, 63141
      • St. John's Mercy Medical Center
  • New Jersey
    • Camden, New Jersey, United States, 08103
      • Cooper University Hospital
  • North Carolina
    • Durham, North Carolina, United States, 27710
      • Duke University Medical Center
    • Winston-Salem, North Carolina, United States, 27157
      • Wake Forest University Baptist Medical Center
    • Winston-Salem, North Carolina, United States, 27517
      • Wake Forest University Health Sciences
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73104
      • University of Oklahoma Health Science Center
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15213
      • University of Pittsburgh Medical Center Presbyterian Hospital
  • Rhode Island
    • Providence, Rhode Island, United States, 02903
      • Rhode Island Hospital
  • Texas
    • El Paso, Texas, United States, 79905
      • Texas Tech University Health Sciences Center
    • Houston, Texas, United States, 77030
      • The Methodist Hospital
    • Houston, Texas, United States, 77030
      • The University of Texas MD Anderson Cancer Center
    • Houston, Texas, United States, 77030
      • Ben Taub General Hospital
    • Temple, Texas, United States, 76508
      • Scott & White Memorial Hospital
  • Utah
    • Salt Lake City, Utah, United States, 84143
      • Intermountain Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: 2; Placebo	Drug: Placebo; Placebo given 3 times a day for up to 28 days or until discharge from the intensive care unit
Experimental: 1; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
All-cause mortality	28-day

Secondary Outcome Measures

Outcome Measure	Time Frame
All-cause mortality	3 months
All-cause mortality	6 months

Collaborators and Investigators

• Sponsor: Agennix
• Investigators: Principal Investigator: Kalpalatha K Guntupalli, MD, Baylor College of Medicine

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: April 1, 2008
• Primary Completion (Actual): August 1, 2009
• Study Completion (Actual): February 1, 2010

Study Registration Dates

• First Submitted: February 28, 2008
• First Submitted That Met QC Criteria: February 28, 2008
• First Posted (Estimate): March 7, 2008

Study Record Updates

• Last Update Posted (Estimate): August 23, 2011
• Last Update Submitted That Met QC Criteria: August 18, 2011
• Last Verified: August 1, 2011

More Information

Terms related to this study

• Keywords: sepsis; lactoferrin; talactoferrin; recombinant human lactoferrin
• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Sepsis; Toxemia; Antineoplastic Agents; Talactoferrin alfa
• Other Study ID Numbers: LF-0801; NIH grant 1R44GM077816-01A2