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

• Sponsor: Universitaire Ziekenhuizen Leuven (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT02707211
• Collaborator: (none)
• Enrollment: 20
• Location: 1
• Arm: 1
• Duration (Months): 8
• Patients Per Site Per Month: 2.5

Study Details

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.

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.

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 20 participants
• Allocation: N/A
• 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: Jun 1, 2016
• Anticipated Primary Completion Date: Feb 1, 2017
• Anticipated Study Completion Date: Feb 1, 2017

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. The level of inflammation [4 weeks]

Secondary Outcome Measures

1. Levels of lysosomal enzymes [4 weeks]

2. the level of cholesterol metabolism [4 weeks]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 2 Years to 64 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	UZ Leuven	Leuven	Vlaams-brabant	Belgium	3000

Sponsors and Collaborators

• Universitaire Ziekenhuizen Leuven

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Annick Vanclooster, Nurse, Universitaire Ziekenhuizen Leuven
• ClinicalTrials.gov Identifier: NCT02707211
• Other Study ID Numbers: Pfizer-Prevenar13-2015
• First Posted: Mar 14, 2016
• Last Update Posted: Mar 15, 2016
• Last Verified: Mar 1, 2016

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Additional relevant MeSH terms: Metabolism, Inborn Errors; Lipid Metabolism, Inborn Errors; Antibodies; Immunoglobulin M

Study Results

No Results Posted as of Mar 15, 2016