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

Sepsis Clinical Trial

— VECTORII  

Official title:

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

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

• Endotoxemia
• Inflammation
• Innate Immune Response
• Sepsis

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