Common Variable ImmunodeficiencyHIGHNCT03534479
Human IgGs and Endothelial Function in Vivo in Humans
A study testing Polyclonal IgG in people with Common Variable Immunodeficiency, run by Federico II University at 1 site in Italy.
Trial summary
Endothelial dysfunction and insulin resistance play a key role in the onset and development of atherosclerosis, cardiovascular diseases, and diabetes. Data in mice models have recently demonstrated that circulating immunoglobulins G (IgG) could be involved in the process. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Common Variable Immunodeficiency
- What is being tested?
- Polyclonal IgG
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteItaly
- Study dates
- Apr 2010to Apr 2013
- Phase
- Interventional
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Common Variable Immunodeficiency
Who cannot join
- Cancer, liver Cirrhosis, recent acute myocardial infarction, treatment with nitroderivates, Reynaud syndrome, heart failure
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Intravenous Human Polyclonal Immunoglobulins G Infusion on Endothelial Function and Insulin Sensitivity in Humans
Endothelial dysfunction and insulin resistance play a key role in the onset and development of atherosclerosis, cardiovascular diseases, and diabetes. Data in mice models have recently demonstrated that circulating immunoglobulins G (IgG) could be involved in the process. Patients with common variable immunodeficiency (CVID), who are characterized by low circulating levels of IgG, might represent an ideal model to clarify the role played in vivo in humans by circulating IgG. Polyclonal IgG, obtained from multiple donors, given intravenously (IVIgG), are used to treat various immunodeficiencies and autoimmune diseases, including CVID. By using this disease and its treatment by IVIgG as a model, aim of the current study is to clarify whether IgG affect endothelial function and insulin sensitivity in humans in vivo and whether the action of IgG on the endothelium involves a direct interaction with the endothelial cells.
Read the detailed description
For this purposes, 24 patients with CVID, receiving the last therapeutic dose of IVIgG infusion 5-weeks before the baseline measurements (CVID-IVIgG group), are studied. In all subjects, endothelial function is evaluated as flow mediated dilation (FMD) of the brachial artery, measured by ultrasonographic technique at baseline and 1, 7, 14, and 21 days after IVIgG infusion. FMD is also measured in a group of IVIgG naive CVID patients (number of patients recruited depending on availability) and a group of control healthy subjects. The latter FMD measurements serve only as a mere reference of pathological or normal values in condition of deficiency or normal levels of circulating IgG and are not used for primary outcome evaluation. To dissect further the mechanisms of improved endothelial function after IVIgG infusion, we investigate the role of human IgG on the production of Nitric Oxide (NO) in vitro on Human Coronary Artery Endothelial Cells (HCAEC) isolated from normal human coronary arteries.
- Conditions
- Common Variable Immunodeficiency
- Being tested
- Polyclonal IgG
- Medical subject headings
- Common Variable Immunodeficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Polyclonal IgGDrug
Also called Immunoglobulins
Measurement of vascular reactivity before and after Infusion of plyclonal Immunoglobulins G in patients with Common variable immunodeficiency
| Study group | Role | What they receive |
|---|---|---|
| CVID-IVIgG, polyclonal IgG i.v. infusion | Experimental | The patients of the CVID-IVIgG, polyclonal IgG infusion, group are studied five weeks from their last therapeutic polyclonal IgG i.v. infusion (IVIgG). On the mornings of day 0, vascular reactivity of the brachial artery, assessed as Flow mediated dilation (FMD), is measured and blood collected for biochemistry (baseline). Immediately after the FMD measurements and the blood collection, the 24 patients receive half dose of IVIgG necessary to treat their disease (400 mg/kg body weight in 10% solution). Twenty-four hours later, before infusing the second half of the dose of the IVIgG, vascular reactivity is again measured and blood collected. Vascular reactivity is again measured 1, 2, and 3 weeks after the first IVIgG infusion. Receives: Drug: Polyclonal IgG |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Endothelial Mediated Vascular Reactivity
Change in vascular reactivity measured by Flow Mediated Dilation of the brachial artery
Measured: 1 day, 1 week, 2 weeks or three weeks after polyclonal IgG infusion
Secondary outcomes (1)
Change in insulin sensitivity
Change in insulin sensitivity measured as change in the Homeostasis model assessment (HOMA-IR) index
Measured: 1 day, 1 week, 2 weeks or three weeks after polyclonal IgG infusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2018
- Study startApr 2010
- Primary completionApr 2013
- Study completionApr 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Common Variable ImmunodeficiencyStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Federico II University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, RAFFAELE NAPOLI, Federico II University
- Investigators
- RAFFAELE NAPOLI, MD, Principal investigator, 1990
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03534479
- Sponsor's protocol ID
- HypoIgG1
- Acronym
- HIGH
- Status last verified
- May 2018
- First submitted
- 10 May 2018
- Last updated
- 23 May 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Intravenous Human Polyclonal Immunoglobulins G Infusion on Endothelial Function and Insulin Sensitivity in Humans
- ClinicalTrials.gov ID
- NCT03534479
- Acronym / sponsor ID
- HIGH / HypoIgG1
- Conditions
- Common Variable Immunodeficiency
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Federico II UniversityUniversity, hospital or other
- Study start
- Apr 2010 (actual)
- Primary completion
- Apr 2013 (actual)
- Study completion
- Apr 2013 (actual)
- First posted
- 23 May 2018 (actual)
- 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.
Endothelial dysfunction and insulin resistance play a key role in the onset and development of atherosclerosis, cardiovascular diseases, and diabetes. Data in mice models have recently demonstrated that circulating immunoglobulins G (IgG) could be involved in the process. Patients with common variable immunodeficiency (CVID), who are characterized by low circulating levels of IgG, might represent an ideal model to clarify the role played in vivo in humans by circulating IgG. Polyclonal IgG, obtained from multiple donors, given intravenously (IVIgG), are used to treat various immunodeficiencies and autoimmune diseases, including CVID. By using this disease and its treatment by IVIgG as a model, aim of the current study is to clarify whether IgG affect endothelial function and insulin sensitivity in humans in vivo and whether the action of IgG on the endothelium involves a direct interaction with the endothelial cells.
Detailed description
For this purposes, 24 patients with CVID, receiving the last therapeutic dose of IVIgG infusion 5-weeks before the baseline measurements (CVID-IVIgG group), are studied. In all subjects, endothelial function is evaluated as flow mediated dilation (FMD) of the brachial artery, measured by ultrasonographic technique at baseline and 1, 7, 14, and 21 days after IVIgG infusion. FMD is also measured in a group of IVIgG naive CVID patients (number of patients recruited depending on availability) and a group of control healthy subjects. The latter FMD measurements serve only as a mere reference of pathological or normal values in condition of deficiency or normal levels of circulating IgG and are not used for primary outcome evaluation. To dissect further the mechanisms of improved endothelial function after IVIgG infusion, we investigate the role of human IgG on the production of Nitric Oxide (NO) in vitro on Human Coronary Artery Endothelial Cells (HCAEC) isolated from normal human coronary arteries.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CVID-IVIgG, polyclonal IgG i.v. infusion | Experimental | Drug: Polyclonal IgGThe patients of the CVID-IVIgG, polyclonal IgG infusion, group are studied five weeks from their last therapeutic polyclonal IgG i.v. infusion (IVIgG). On the mornings of day 0, vascular reactivity of the brachial artery, assessed as Flow mediated dilation (FMD), is measured and blood collected for biochemistry (baseline). Immediately after the FMD measurements and the blood collection, the 24 patients receive half dose of IVIgG necessary to treat their disease (400 mg/kg body weight in 10% solution). Twenty-four hours later, before infusing the second half of the dose of the IVIgG, vascular reactivity is again measured and blood collected. Vascular reactivity is again measured 1, 2, and 3 weeks after the first IVIgG infusion. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Common Variable Immunodeficiency
Key exclusion criteria (1 listed)
- Cancer, liver Cirrhosis, recent acute myocardial infarction, treatment with nitroderivates, Reynaud syndrome, heart failure
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 |
|---|---|---|
| Polyclonal IgGAlso: ImmunoglobulinsMeasurement of vascular reactivity before and after Infusion of plyclonal Immunoglobulins G in patients with Common variable immunodeficiency | Drug | CVID-IVIgG, polyclonal IgG i.v. infusion |
Primary outcome
Change in Endothelial Mediated Vascular Reactivity
Time frame: 1 day, 1 week, 2 weeks or three weeks after polyclonal IgG infusion
Change in vascular reactivity measured by Flow Mediated Dilation of the brachial artery
1 secondary outcome
Change in insulin sensitivity
Time frame: 1 day, 1 week, 2 weeks or three weeks after polyclonal IgG infusion
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 23 May 2018.
- Individual participant dataSharing planned: No
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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.
RAFFAELE NAPOLI, MD principal investigator
1990
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Polyclonal IgG in people with Common Variable Immunodeficiency, run by Federico II University at 1 site in Italy.
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 1 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 23 May 2018. 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 Italy. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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?
Change in Endothelial Mediated Vascular Reactivity (time frame: 1 day, 1 week, 2 weeks or three weeks after polyclonal IgG infusion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 23 May 2018.