Inflammation Clinical Trial
— VECTOROfficial title:
In Vivo Effects of C1-esterase Inhibitor on the Innate Immune Response During Human Endotoxemia
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 |
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.
Status | Completed |
Enrollment | 20 |
Est. completion date | August 2009 |
Est. primary completion date | December 2008 |
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-, alcohol abuses - Tendency towards fainting - Hyper- or hypotension |
Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Basic Science
Country | Name | City | State |
---|---|---|---|
Netherlands | Radboud University Nijmegen Medical Centre | Nijmegen |
Lead Sponsor | Collaborator |
---|---|
Radboud University |
Netherlands,
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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