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

Lipid Metabolism, Inborn Errors Clinical Trial

Official title:

Immunization Against oxLDL in Patients With Lysosomal Lipid Diseases and Associated Metabolic Disorders

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02707211
• Other study ID #: Pfizer-Prevenar13-2015
• Status: Not yet recruiting
• Phase: Phase 0
• First received: January 20, 2016
• Last updated: March 14, 2016
• Start date: June 2016
• Est. completion date: February 2017

Study information

• Verified date: March 2016
• Source: Universitaire Ziekenhuizen Leuven
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: FAGG
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 20
• Est. completion date: February 2017
• Est. primary completion date: February 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 2 Years to 64 Years

Eligibility

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.

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Lipid Metabolism, Inborn Errors
• Metabolism, Inborn Errors

Intervention

Biological:
• Anti-oxLDL IgM antibody
Immunization

Locations

Country	Name	City	State
Belgium	UZ Leuven	Leuven	Vlaams-brabant

Sponsors (1)

Lead Sponsor	Collaborator
Universitaire Ziekenhuizen Leuven

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The level of inflammation		4 weeks	No
Secondary	Levels of lysosomal enzymes		4 weeks	No
Secondary	the level of cholesterol metabolism		4 weeks	No