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

NCT ID: NCT01766414

Last Updated: 2014-12-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-09-30

Study Completion Date

2014-01-31

Brief Summary

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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

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Conditions

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Innate Immune Response Endotoxemia Inflammation Sepsis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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C1-esterase inhibitor

C1-esterase inhibitor 100 U/kg infusion followed by administration of Endotoxin 2ng/kg

Group Type ACTIVE_COMPARATOR

C1-esterase inhibitor

Intervention Type DRUG

intravenously

Endotoxin

Intervention Type DRUG

intravenously

Placebo

Placebo (saline 0.9%) infusion followed by administration of Endotoxin 2ng/kg

Group Type PLACEBO_COMPARATOR

Endotoxin

Intervention Type DRUG

intravenously

Interventions

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C1-esterase inhibitor

intravenously

Intervention Type DRUG

Endotoxin

intravenously

Intervention Type DRUG

Other Intervention Names

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

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

35 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Radboud University Medical Center

OTHER

Sponsor Role lead

UMC Utrecht

OTHER

Sponsor Role collaborator

Prothya Biosolutions

INDUSTRY

Sponsor Role collaborator

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Hans Hoeven, Prof

Role: STUDY_DIRECTOR

UMC Nijmegen

Locations

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Radboud University

Nijmegen, , Netherlands

Site Status

Countries

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Netherlands

References

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Tak T, Wijten P, Heeres M, Pickkers P, Scholten A, Heck AJR, Vrisekoop N, Leenen LP, Borghans JAM, Tesselaar K, Koenderman L. Human CD62Ldim neutrophils identified as a separate subset by proteome profiling and in vivo pulse-chase labeling. Blood. 2017 Jun 29;129(26):3476-3485. doi: 10.1182/blood-2016-07-727669. Epub 2017 May 17.

Reference Type DERIVED
PMID: 28515092 (View on PubMed)

Other Identifiers

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2011-002222-46

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

36688

Identifier Type: -

Identifier Source: org_study_id