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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Agennix
ClinicalTrials.gov Identifier:
NCT00630656
First received: February 28, 2008
Last updated: August 18, 2011
Last verified: August 2011
  Purpose

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


Condition Intervention Phase
Severe Sepsis
Drug: Talactoferrin alfa
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Phase 2 Randomized, Double-blind, Placebo-controlled Study of the Safety and Efficacy of Talactoferrin Alfa in Patients With Severe Sepsis

Resource links provided by NLM:


Further study details as provided by Agennix:

Primary Outcome Measures:
  • All-cause mortality [ Time Frame: 28-day ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • All-cause mortality [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • All-cause mortality [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Enrollment: 190
Study Start Date: April 2008
Study Completion Date: February 2010
Primary Completion Date: August 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00630656

  Show 34 Study Locations
Sponsors and Collaborators
Agennix
Investigators
Principal Investigator: Kalpalatha K Guntupalli, MD Baylor College of Medicine
  More Information

No publications provided by Agennix

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Agennix
ClinicalTrials.gov Identifier: NCT00630656     History of Changes
Other Study ID Numbers: LF-0801, NIH grant 1R44GM077816-01A2
Study First Received: February 28, 2008
Last Updated: August 18, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Agennix:
sepsis
talactoferrin
lactoferrin
recombinant human lactoferrin

Additional relevant MeSH terms:
Sepsis
Toxemia
Infection
Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes
Lactoferrin
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 27, 2014