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NCT Number: NCT01766414

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

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.

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Key information

Conditions

Innate Immune Response Bacteremia Endotoxemia Infections Inflammation Pathologic Processes Pathological Conditions, Signs and Symptoms Sepsis Systemic Inflammatory Response Syndrome Toxemia

Age range

18 year–35 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 3

Primary location

Radboud University

Nijmegen, Netherlands

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

C1-Esterase Inhibitor

Drug

intravenously

Other names: Cetor

Endotoxin

Drug

intravenously

Other names: 2 ng/kg E. coli reference endotoxin 11:H 10:K negative

Primary outcomes

  1. Neutrophil phenotype and redistribution

    Time frame: 8 hrs after LPS administration

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Radboud University Medical Center

Other

Collaborators

  • Prothya Biosolutions
  • UMC Utrecht

Registry information

Official study title

In Vivo Effects of C1-esterase Inhibitor on the Innate Immune Response During Human Endotoxemia - A Randomized Controlled Pilot Study

Acronym: VECTORII

Important dates

Study start
2013
Primary completion
2013
Study completion
2014
First posted
Jan 11, 2013
Registry last updated
Dec 2, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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