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

Radboud University Medical Center

Status and phase: Completed; Phase 3

Conditions: Inflammation; Innate Immune Response; Endotoxemia; Sepsis

Treatments: Drug: Endotoxin; Drug: C1-esterase inhibitor

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01766414

2011-002222-46 (EudraCT Number)

36688

Details and patient eligibility

About

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.

Enrollment: 20 patients

Sex: Male

Ages: 18 to 35 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

---

20 participants in 2 patient groups, including a placebo group

C1-esterase inhibitor

Active Comparator group

Description:

C1-esterase inhibitor 100 U/kg infusion followed by administration of Endotoxin 2ng/kg

Treatment:

Drug: C1-esterase inhibitor

Drug: Endotoxin

Placebo

Placebo Comparator group

Description:

Placebo (saline 0.9%) infusion followed by administration of Endotoxin 2ng/kg

Treatment:

Drug: Endotoxin