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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00630656
Recruitment Status : Completed
First Posted : March 7, 2008
Last Update Posted : August 23, 2011
Sponsor:
Information provided by (Responsible Party):
Agennix

Tracking Information
First Submitted Date  ICMJE February 28, 2008
First Posted Date  ICMJE March 7, 2008
Last Update Posted Date August 23, 2011
Study Start Date  ICMJE April 2008
Actual Primary Completion Date August 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 28, 2008)
All-cause mortality [ Time Frame: 28-day ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 28, 2008)
  • All-cause mortality [ Time Frame: 3 months ]
  • All-cause mortality [ Time Frame: 6 months ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Safety and Efficacy Study of Recombinant Human Lactoferrin to Treat Severe Sepsis
Official Title  ICMJE A Phase 2 Randomized, Double-blind, Placebo-controlled Study of the Safety and Efficacy of Talactoferrin Alfa in Patients With Severe Sepsis
Brief Summary Study will evaluate the safety and potential benefit of recombinant human talactoferrin as an addition to the standard care of severe sepsis.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Severe Sepsis
Intervention  ICMJE
  • 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
  • Drug: Placebo
    Placebo given 3 times a day for up to 28 days or until discharge from the intensive care unit
Study Arms  ICMJE
  • Experimental: 1
    Talactoferrin alfa
    Intervention: Drug: Talactoferrin alfa
  • Placebo Comparator: 2
    Placebo
    Intervention: Drug: Placebo
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 28, 2008)
190
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE February 2010
Actual Primary Completion Date August 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada,   France,   Germany,   Spain,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00630656
Other Study ID Numbers  ICMJE LF-0801
NIH grant 1R44GM077816-01A2
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Agennix
Study Sponsor  ICMJE Agennix
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Kalpalatha K Guntupalli, MD Baylor College of Medicine
PRS Account Agennix
Verification Date August 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP