Innate Immune ResponsePhase 3VECTORIINCT01766414
In Vivo Effects of C1-esterase Inhibitor on the Innate Immune Response During Human Endotoxemia - VECTOR II
A Phase 3 study testing C1-esterase inhibitor and Endotoxin in people with Innate Immune Response and Endotoxemia, run by Radboud University Medical Center at 1 site in Netherlands.
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). Read more about this study
- Who is it for?
- Ages 18 to 35 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Innate Immune Response, Endotoxemia, Inflammation
- What is being tested?
- C1-esterase inhibitor and Endotoxin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteNetherlands
- Study dates
- Sep 2013to Jan 2014
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy male volunteers (18-35 years old)
Who cannot join
- Relevant medical history
- Drug-, nicotine-abuses
- Tendency towards fainting
- Hyper- or hypotension
- Use of any medication
Trial locations and contacts
1 site in 1 country.
About this study
Official title: In Vivo Effects of C1-esterase Inhibitor on the Innate Immune Response During Human Endotoxemia - A Randomized Controlled Pilot Study
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.
- Conditions
- Innate Immune Response, Endotoxemia, Inflammation, Sepsis
- Being tested
- C1-esterase inhibitor, Endotoxin
- Medical subject headings
- Endotoxemia, Inflammation, Sepsis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
C1-esterase inhibitorDrug
Also called Cetor
intravenously
EndotoxinDrug
Also called 2 ng/kg E. coli reference endotoxin 11:H 10:K negative
intravenously
| Study group | Role | What they receive |
|---|---|---|
| C1-esterase inhibitor | Active comparator | C1-esterase inhibitor 100 U/kg infusion followed by administration of Endotoxin 2ng/kg Receives: Drug: C1-esterase inhibitor; Drug: Endotoxin |
| Placebo | Placebo comparator | Placebo (saline 0.9%) infusion followed by administration of Endotoxin 2ng/kg Receives: Drug: Endotoxin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neutrophil phenotype and redistribution
Measured: 8 hrs after LPS administration
Secondary outcomes (2)
Cytokines and other markers of inflammation
Measured: 8 hrs after LPS administration
C1-inhibitor and complement concentration and activity
Measured: 8 hrs after LPS administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2013 (estimated)
- Study startSep 2013
- Primary completionOct 2013
- Study completionJan 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Innate Immune ResponseStudies of the same condition, open and under way.
- More trials run by Radboud University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Radboud University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- UMC Utrecht, Prothya Biosolutions
- Responsible party
- Sponsor
- Investigators
- Hans Hoeven, Prof, Study director, UMC Nijmegen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01766414
- Sponsor's protocol ID
- 36688
- Other IDs
- 2011-002222-46
- Acronym
- VECTORII
- Status last verified
- Nov 2014
- First submitted
- 4 Jan 2013
- Last updated
- 2 Dec 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Tak T, Wijten P, Heeres M, Pickkers P, Scholten A, Heck AJR, Vrisekoop N, Leenen LP, Borghans JAM, Tesselaar K, Koenderman L. Human CD62Ldim neutrophils identified as a separate subset by proteome profiling and in vivo pulse-chase labeling. Blood. 2017 Jun 29;129(26):3476-3485. doi: 10.1182/blood-2016-07-727669. Epub 2017 May 17.
PubMed 28515092
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- In Vivo Effects of C1-esterase Inhibitor on the Innate Immune Response During Human Endotoxemia - A Randomized Controlled Pilot Study
- ClinicalTrials.gov ID
- NCT01766414
- Acronym / sponsor ID
- VECTORII / 36688
- Conditions
- Innate Immune Response, Endotoxemia, Inflammation, Sepsis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Radboud University Medical CenterUniversity, hospital or other
- Collaborators
- UMC Utrecht, Prothya Biosolutions
- Study start
- Sep 2013
- Primary completion
- Oct 2013 (actual)
- Study completion
- Jan 2014 (actual)
- First posted
- 11 Jan 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| C1-esterase inhibitor | Active comparator | Drug: C1-esterase inhibitor, Drug: EndotoxinC1-esterase inhibitor 100 U/kg infusion followed by administration of Endotoxin 2ng/kg |
| Placebo | Placebo comparator | Drug: EndotoxinPlacebo (saline 0.9%) infusion followed by administration of Endotoxin 2ng/kg |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Healthy male volunteers (18-35 years old)
Key exclusion criteria (5 listed)
- Relevant medical history
- Drug-, nicotine-abuses
- Tendency towards fainting
- Hyper- or hypotension
- Use of any medication
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| C1-esterase inhibitorAlso: Cetorintravenously | Drug | C1-esterase inhibitor |
| EndotoxinAlso: 2 ng/kg E. coli reference endotoxin 11:H 10:K negativeintravenously | Drug | C1-esterase inhibitor, Placebo |
Primary outcome
Neutrophil phenotype and redistribution
Time frame: 8 hrs after LPS administration
2 secondary outcomes
Cytokines and other markers of inflammation
Time frame: 8 hrs after LPS administration
C1-inhibitor and complement concentration and activity
Time frame: 8 hrs after LPS administration
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2014.
- Derived from this study: PubMed 28515092Tak T, Wijten P, Heeres M, Pickkers P, Scholten A, Heck AJR, Vrisekoop N, Leenen LP, Borghans JAM, Tesselaar K, Koenderman L. Human CD62Ldim neutrophils identified as a separate subset by proteome profiling and in vivo pulse-chase labeling. Blood. 2017 Jun 29;129(26):3476-3485. doi: 10.1182/blood-2016-07-727669. Epub 2017 May 17.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hans Hoeven, Prof study director
UMC Nijmegen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing C1-esterase inhibitor and Endotoxin in people with Innate Immune Response and Endotoxemia, run by Radboud University Medical Center at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Neutrophil phenotype and redistribution (time frame: 8 hrs after LPS administration). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01766414, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Dec 2014.