Anti-oxLDL IgM antibodies as a novel therapy for metabolic lipid diseases

Phase 1

• Conditions: Familial hypercholesterolemia Niemann-Pick disease type B (NPB)Niemann-Pick disease type C (NPC)Partial lipodystrophy in children and adults; Therapeutic area: Body processes [G] - Metabolic Phenomena [G03]

• Registration Number: EUCTR2015-004846-25-BE
• Lead Sponsor: Maastricht University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2016-03-30
• Last Update Posted: 8 August 2016

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

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

Are the trial subjects under 18? yes
Number of subjects for this age range: 5
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 7
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

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

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified