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

Phase 3

Completed

• Conditions: Innate Immune Response; Inflammation; Endotoxemia; Sepsis
• Interventions: Drug: C1-esterase inhibitor; Drug: Endotoxin

• Registration Number: NCT01766414
• Lead Sponsor: Radboud University Medical Center

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-01-04
• Study First Submitted QC: 2013-01-09
• Study First Posted: 2013-01-11
• Study Start: 2013-09
• Primary Completion: 2013-10
• Study Completion: 2014-01
• Status Verified: 2014-11
• Last Update Submitted: 2014-11-27
• Last Update Posted: 2014-12-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 20

Inclusion Criteria

• Healthy male volunteers (18-35 years old)

Read More

Exclusion Criteria

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

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
C1-esterase inhibitor	C1-esterase inhibitor	C1-esterase inhibitor 100 U/kg infusion followed by administration of Endotoxin 2ng/kg
Placebo	Endotoxin	Placebo (saline 0.9%) infusion followed by administration of Endotoxin 2ng/kg
C1-esterase inhibitor	Endotoxin	C1-esterase inhibitor 100 U/kg infusion followed by administration of Endotoxin 2ng/kg

Primary Outcome Measures

Name	Time	Method
Neutrophil phenotype and redistribution	8 hrs after LPS administration

Secondary Outcome Measures

Name	Time	Method
Cytokines and other markers of inflammation	8 hrs after LPS administration
C1-inhibitor and complement concentration and activity	8 hrs after LPS administration

Trial Locations

Locations (1)

Radboud University; 🇳🇱 Nijmegen, Netherlands