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Anti-oxLDL IgM Antibodies as a Novel Therapy for Metabolic Lipid Diseases

Primary Purpose

Lipid Metabolism, Inborn Errors

Status
Unknown status
Phase
Early Phase 1
Locations
Belgium
Study Type
Interventional
Intervention
Anti-oxLDL IgM antibody
Sponsored by
Universitaire Ziekenhuizen KU Leuven
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lipid Metabolism, Inborn Errors

Eligibility Criteria

2 Years - 64 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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.

Sites / Locations

  • UZ Leuven

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Anti-oxLDL IgM antibodies

Arm Description

administration Anti-oxLDL IgM antibodies

Outcomes

Primary Outcome Measures

The level of inflammation

Secondary Outcome Measures

Levels of lysosomal enzymes
the level of cholesterol metabolism

Full Information

First Posted
January 20, 2016
Last Updated
March 14, 2016
Sponsor
Universitaire Ziekenhuizen KU Leuven
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1. Study Identification

Unique Protocol Identification Number
NCT02707211
Brief Title
Anti-oxLDL IgM Antibodies as a Novel Therapy for Metabolic Lipid Diseases
Official Title
Immunization Against oxLDL in Patients With Lysosomal Lipid Diseases and Associated Metabolic Disorders
Study Type
Interventional

2. Study Status

Record Verification Date
March 2016
Overall Recruitment Status
Unknown status
Study Start Date
June 2016 (undefined)
Primary Completion Date
February 2017 (Anticipated)
Study Completion Date
February 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universitaire Ziekenhuizen KU Leuven

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lipid Metabolism, Inborn Errors

7. Study Design

Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Anti-oxLDL IgM antibodies
Arm Type
Experimental
Arm Description
administration Anti-oxLDL IgM antibodies
Intervention Type
Biological
Intervention Name(s)
Anti-oxLDL IgM antibody
Intervention Description
Immunization
Primary Outcome Measure Information:
Title
The level of inflammation
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
Levels of lysosomal enzymes
Time Frame
4 weeks
Title
the level of cholesterol metabolism
Time Frame
4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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.
Facility Information:
Facility Name
UZ Leuven
City
Leuven
State/Province
Vlaams-brabant
ZIP/Postal Code
3000
Country
Belgium

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Anti-oxLDL IgM Antibodies as a Novel Therapy for Metabolic Lipid Diseases

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