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In Vivo Effects of C1-esterase Inhibitor on the Innate Immune Response During Human Endotoxemia - VECTOR II (VECTORII)

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ClinicalTrials.gov Identifier: NCT01766414
Recruitment Status : Completed
First Posted : January 11, 2013
Last Update Posted : December 2, 2014
Sponsor:
Collaborators:
UMC Utrecht
Sanquin
Information provided by (Responsible Party):
Radboud University

Brief Summary:

Excessive inflammation is associated with tissue damage caused by over-activation of the innate immune system. This can range from mild disease to extreme conditions, such as multiple organ dysfunction syndrome (MODS) and acute respiratory distress (ARDS). In marked contrast to adaptive immunity which is very sensitive to immune modulators such as steroids, the innate immune system cannot be sufficiently targeted by currently available anti-inflammatory drugs.

The investigators hypothesize that pre-treatment with C1-esterase inhibitor in a human endotoxemia model can modulate the innate immune response.

In this study, human endotoxemia will be used as a model for inflammation. Subjects will, prior to endotoxin administration, receive C1 esterase inhibitor or placebo. Blood will be sampled to determine the levels of markers of the innate immune response.


Condition or disease Intervention/treatment Phase
Innate Immune Response Endotoxemia Inflammation Sepsis Drug: C1-esterase inhibitor Drug: Endotoxin Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Basic Science
Official Title: In Vivo Effects of C1-esterase Inhibitor on the Innate Immune Response During Human Endotoxemia - A Randomized Controlled Pilot Study
Study Start Date : September 2013
Actual Primary Completion Date : October 2013
Actual Study Completion Date : January 2014

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: C1-esterase inhibitor
C1-esterase inhibitor 100 U/kg infusion followed by administration of Endotoxin 2ng/kg
Drug: C1-esterase inhibitor
intravenously
Other Name: Cetor

Drug: Endotoxin
intravenously
Other Name: 2 ng/kg E. coli reference endotoxin 11:H 10:K negative

Placebo Comparator: Placebo
Placebo (saline 0.9%) infusion followed by administration of Endotoxin 2ng/kg
Drug: Endotoxin
intravenously
Other Name: 2 ng/kg E. coli reference endotoxin 11:H 10:K negative




Primary Outcome Measures :
  1. Neutrophil phenotype and redistribution [ Time Frame: 8 hrs after LPS administration ]

Secondary Outcome Measures :
  1. Cytokines and other markers of inflammation [ Time Frame: 8 hrs after LPS administration ]
  2. C1-inhibitor and complement concentration and activity [ Time Frame: 8 hrs after LPS administration ]


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Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy male volunteers (18-35 years old)

Exclusion Criteria:

  • Relevant medical history
  • Drug-, nicotine-abuses
  • Tendency towards fainting
  • Hyper- or hypotension
  • Use of any medication

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01766414


Locations
Netherlands
Radboud University
Nijmegen, Netherlands
Sponsors and Collaborators
Radboud University
UMC Utrecht
Sanquin
Investigators
Study Director: Hans Hoeven, Prof UMC Nijmegen

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Radboud University
ClinicalTrials.gov Identifier: NCT01766414     History of Changes
Other Study ID Numbers: 36688
2011-002222-46 ( EudraCT Number )
First Posted: January 11, 2013    Key Record Dates
Last Update Posted: December 2, 2014
Last Verified: November 2014

Additional relevant MeSH terms:
Inflammation
Endotoxemia
Pathologic Processes
Bacteremia
Sepsis
Infection
Toxemia
Systemic Inflammatory Response Syndrome
Complement C1s
Complement C1 Inhibitor Protein
Complement C1 Inactivator Proteins
Immunologic Factors
Physiological Effects of Drugs
Complement Inactivating Agents
Immunosuppressive Agents