Lipid Metabolism, Inborn ErrorsEarly Phase 1NCT02707211
Anti-oxLDL IgM Antibodies as a Novel Therapy for Metabolic Lipid Diseases
A Early Phase 1 study testing Anti-oxLDL IgM antibody in people with Lipid Metabolism, Inborn Errors, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
Trial summary
To test whether active pneumococci immunization can alleviate inflammation and improve cholesterol metabolism in lysosomal lipid storage diseases and associated metabolic disorders. Read more about this study
- Who is it for?
- Ages 2 to 64 years
- Conditions the study is for
- Lipid Metabolism, Inborn Errors
- What is being tested?
- Anti-oxLDL IgM antibody
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteBelgium
- Study dates
- Jun 2016to Feb 2017
- Phase
- Early Phase 1
- 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 2 to 64 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Patients of following diseases (characterized by lysosomal lipid storage or associated metabolic pathology)
- Familial hypercholesterolemia,
- NPB,
- NPC
- Partial lipodystrophy (PPARg mutations and laminin A/C mutations)
- Intention to be treated and participate to the treatment - Written informed consent
Who cannot join
- Medical conditions that may interfere with the study procedures: cancer Hodgkin lymphoma (all related to immune cells); autoimmune diseases; immune deficiency; splenectomy syndrome
- Alcohol abuse (quantitative limit >20g/day for men and >10g for women)
- Illiteracy
- Patients younger than 10 years.
- Any condition which in the opinion of the (co-) investigator might interfere with the evaluation of the study objectives.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Immunization Against oxLDL in Patients With Lysosomal Lipid Diseases and Associated Metabolic Disorders
To test whether active pneumococci immunization can alleviate inflammation and improve cholesterol metabolism in lysosomal lipid storage diseases and associated metabolic disorders.
Read the detailed description
Growing evidence describes the central role of oxidized low density lipoproteins (oxLDL) in diseases related to lipid metabolism. Moreover, oxLDL has been shown to be involved in pathological processes such as an inappropriate inflammatory response, disturbance of cholesterol metabolism and dysfunction of the lysosomal apparatus. Relevantly, it has been shown that immunizing mice with Streptococcus pneumoniae results in higher serum titers of anti-oxLDL IgM antibodies due to molecular mimicry.
- Conditions
- Lipid Metabolism, Inborn Errors
- Being tested
- Anti-oxLDL IgM antibody
- Medical subject headings
- Lipid Metabolism, Inborn Errors
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anti-oxLDL IgM antibodyBiological
Immunization
| Study group | Role | What they receive |
|---|---|---|
| Anti-oxLDL IgM antibodies | Experimental | administration Anti-oxLDL IgM antibodies Receives: Biological: Anti-oxLDL IgM antibody |
What is being measured
The primary outcome is the main question the study is designed to answer.
The level of inflammation
Measured: 4 weeks
Secondary outcomes (2)
Levels of lysosomal enzymes
Measured: 4 weeks
the level of cholesterol metabolism
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2016 (estimated)
- Study startJun 2016
- Primary completionFeb 2017 (estimated)
- Study completionFeb 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lipid Metabolism, Inborn ErrorsStudies of the same condition, open and under way.
- More trials run by Universitaire Ziekenhuizen KU LeuvenThe 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universitaire Ziekenhuizen KU Leuven
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Annick Vanclooster, Universitaire Ziekenhuizen KU Leuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02707211
- Sponsor's protocol ID
- Pfizer-Prevenar13-2015
- Status last verified
- Mar 2016
- First submitted
- 20 Jan 2016
- Last updated
- 15 Mar 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immunization Against oxLDL in Patients With Lysosomal Lipid Diseases and Associated Metabolic Disorders
- ClinicalTrials.gov ID
- NCT02707211
- Acronym / sponsor ID
- Pfizer-Prevenar13-2015
- Conditions
- Lipid Metabolism, Inborn Errors
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Universitaire Ziekenhuizen KU LeuvenUniversity, hospital or other
- Study start
- Jun 2016
- Primary completion
- Feb 2017 (estimated)
- Study completion
- Feb 2017 (estimated)
- First posted
- 14 Mar 2016 (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.
To test whether active pneumococci immunization can alleviate inflammation and improve cholesterol metabolism in lysosomal lipid storage diseases and associated metabolic disorders.
Detailed description
Growing evidence describes the central role of oxidized low density lipoproteins (oxLDL) in diseases related to lipid metabolism. Moreover, oxLDL has been shown to be involved in pathological processes such as an inappropriate inflammatory response, disturbance of cholesterol metabolism and dysfunction of the lysosomal apparatus. Relevantly, it has been shown that immunizing mice with Streptococcus pneumoniae results in higher serum titers of anti-oxLDL IgM antibodies due to molecular mimicry.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Anti-oxLDL IgM antibodies | Experimental | Biological: Anti-oxLDL IgM antibodyadministration Anti-oxLDL IgM antibodies |
Who may qualify
- Ages
- 2 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- Patients of following diseases (characterized by lysosomal lipid storage or associated metabolic pathology)
- Intention to be treated and participate to the treatment - Written informed consent
Key exclusion criteria (5 listed)
- Medical conditions that may interfere with the study procedures: cancer Hodgkin lymphoma (all related to immune cells); autoimmune diseases; immune deficiency; splenectomy syndrome
- Alcohol abuse (quantitative limit >20g/day for men and >10g for women)
- Illiteracy
- Patients younger than 10 years.
- Any condition which in the opinion of the (co-) investigator might interfere with the evaluation of the study objectives.
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 |
|---|---|---|
| Anti-oxLDL IgM antibodyImmunization | Biological | Anti-oxLDL IgM antibodies |
Primary outcome
The level of inflammation
Time frame: 4 weeks
2 secondary outcomes
Levels of lysosomal enzymes
Time frame: 4 weeks
the level of cholesterol metabolism
Time frame: 4 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2016.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Anti-oxLDL IgM antibody in people with Lipid Metabolism, Inborn Errors, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
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 6 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: status not confirmed, as of the sponsor's last update on 15 Mar 2016. 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 Belgium. 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.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
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?
The level of inflammation (time frame: 4 weeks). 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 15 Mar 2016.