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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00785018
Other study ID # VECTOR study 2008/197
Secondary ID
Status Completed
Phase N/A
First received November 4, 2008
Last updated April 21, 2011
Start date November 2008
Est. completion date August 2009

Study information

Verified date May 2009
Source Radboud University
Contact n/a
Is FDA regulated No
Health authority Netherlands: Medical Ethics Review Committee (METC)
Study type Interventional

Clinical Trial 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 failure (MOF). 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.

We hypothesize that C1-esterase inhibitor can modulate the innate immune response.

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


Description:

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Study Design

Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Basic Science


Intervention

Drug:
C1-esterase inhibitor
C1-esterase inhibitor 100 U/kg infusion over 30 minutes.
Endotoxin administration
2 ng/kg E. coli reference endotoxin 11:H 10:K negative intravenously

Locations

Country Name City State
Netherlands Radboud University Nijmegen Medical Centre Nijmegen

Sponsors (1)

Lead Sponsor Collaborator
Radboud University

Country where clinical trial is conducted

Netherlands, 

Outcome

Type Measure Description Time frame Safety issue
Primary Cytokines and other markers of Inflammation 24 hrs after LPS administration No
Primary Neutrophil redistribution and phenotype 24 hours after LPS administration No
Primary C1-inhibitor and complement concentration and activity 24 hours after LPS administration No
Primary Hemodynamic response 24 hours after LPS administration No
Primary Markers of Renal Injury 24 hours after LPS administration No
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