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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01766414
Other study ID # 36688
Secondary ID 2011-002222-46
Status Completed
Phase Phase 3
First received January 4, 2013
Last updated November 27, 2014
Start date September 2013
Est. completion date January 2014

Study information

Verified date November 2014
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 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.


Recruitment information / eligibility

Status Completed
Enrollment 20
Est. completion date January 2014
Est. primary completion date October 2013
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 18 Years to 35 Years
Eligibility 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 Design

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


Related Conditions & MeSH terms


Intervention

Drug:
C1-esterase inhibitor
intravenously
Endotoxin
intravenously

Locations

Country Name City State
Netherlands Radboud University Nijmegen

Sponsors (3)

Lead Sponsor Collaborator
Radboud University Sanquin, UMC Utrecht

Country where clinical trial is conducted

Netherlands, 

Outcome

Type Measure Description Time frame Safety issue
Primary Neutrophil phenotype and redistribution 8 hrs after LPS administration No
Secondary Cytokines and other markers of inflammation 8 hrs after LPS administration No
Secondary C1-inhibitor and complement concentration and activity 8 hrs after LPS administration No
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