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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02707211
Recruitment Status : Unknown
Verified March 2016 by Annick Vanclooster, Universitaire Ziekenhuizen Leuven.
Recruitment status was:  Not yet recruiting
First Posted : March 14, 2016
Last Update Posted : March 15, 2016
Sponsor:
Information provided by (Responsible Party):
Annick Vanclooster, Universitaire Ziekenhuizen Leuven

Brief Summary:
To test whether active pneumococci immunization can alleviate inflammation and improve cholesterol metabolism in lysosomal lipid storage diseases and associated metabolic disorders.

Condition or disease Intervention/treatment Phase
Lipid Metabolism, Inborn Errors Biological: Anti-oxLDL IgM antibody Early Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Immunization Against oxLDL in Patients With Lysosomal Lipid Diseases and Associated Metabolic Disorders
Study Start Date : June 2016
Estimated Primary Completion Date : February 2017
Estimated Study Completion Date : February 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Anti-oxLDL IgM antibodies
administration Anti-oxLDL IgM antibodies
Biological: Anti-oxLDL IgM antibody
Immunization




Primary Outcome Measures :
  1. The level of inflammation [ Time Frame: 4 weeks ]

Secondary Outcome Measures :
  1. Levels of lysosomal enzymes [ Time Frame: 4 weeks ]
  2. the level of cholesterol metabolism [ Time Frame: 4 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   2 Years to 64 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02707211


Locations
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Belgium
UZ Leuven
Leuven, Vlaams-brabant, Belgium, 3000
Sponsors and Collaborators
Universitaire Ziekenhuizen Leuven

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Responsible Party: Annick Vanclooster, Nurse, Universitaire Ziekenhuizen Leuven
ClinicalTrials.gov Identifier: NCT02707211    
Other Study ID Numbers: Pfizer-Prevenar13-2015
First Posted: March 14, 2016    Key Record Dates
Last Update Posted: March 15, 2016
Last Verified: March 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Additional relevant MeSH terms:
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Metabolism, Inborn Errors
Lipid Metabolism, Inborn Errors
Genetic Diseases, Inborn
Metabolic Diseases
Lipid Metabolism Disorders
Antibodies
Immunoglobulins
Immunologic Factors
Physiological Effects of Drugs