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

November 27, 2014 updated by: Radboud University Medical Center

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 35 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: BASIC_SCIENCE
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / 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 Names:
  • Cetor
Drug: Endotoxin
intravenously
Other Names:
  • 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 Names:
  • 2 ng/kg E. coli reference endotoxin 11:H 10:K negative

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Neutrophil phenotype and redistribution
Time Frame: 8 hrs after LPS administration
8 hrs after LPS administration

Secondary Outcome Measures

Outcome Measure
Time Frame
Cytokines and other markers of inflammation
Time Frame: 8 hrs after LPS administration
8 hrs after LPS administration
C1-inhibitor and complement concentration and activity
Time Frame: 8 hrs after LPS administration
8 hrs after LPS administration

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Radboud University Medical Center

Collaborators

UMC Utrecht
Prothya Biosolutions

Investigators

  • Study Director: Hans Hoeven, Prof, UMC Nijmegen

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2013

Primary Completion (ACTUAL)

October 1, 2013

Study Completion (ACTUAL)

January 1, 2014

Study Registration Dates

First Submitted

January 4, 2013

First Submitted That Met QC Criteria

January 9, 2013

First Posted (ESTIMATE)

January 11, 2013

Study Record Updates

Last Update Posted (ESTIMATE)

December 2, 2014

Last Update Submitted That Met QC Criteria

November 27, 2014

Last Verified

November 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 36688
  • 2011-002222-46 (EUDRACT_NUMBER)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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