NCT02707211

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at P25-P50 for early_phase_1

Timeline
Completed

Started Jun 2016

Shorter than P25 for early_phase_1

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 20, 2016

Completed
2 months until next milestone

First Posted

Study publicly available on registry

March 14, 2016

Completed
3 months until next milestone

Study Start

First participant enrolled

June 1, 2016

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2017

Completed
Last Updated

March 15, 2016

Status Verified

March 1, 2016

Enrollment Period

8 months

First QC Date

January 20, 2016

Last Update Submit

March 14, 2016

Conditions

Lipid Metabolism, Inborn Errors

Outcome Measures

Primary Outcomes (1)

  • The level of inflammation

    4 weeks

Secondary Outcomes (2)

  • Levels of lysosomal enzymes

    4 weeks

  • the level of cholesterol metabolism

    4 weeks

Study Arms (1)

Anti-oxLDL IgM antibodies

EXPERIMENTAL

administration Anti-oxLDL IgM antibodies

Biological: Anti-oxLDL IgM antibody

Interventions

Anti-oxLDL IgM antibodyBIOLOGICAL

Immunization

Anti-oxLDL IgM antibodies

Eligibility Criteria

Age2 Years - 64 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UZ Leuven

Leuven, Vlaams-brabant, 3000, Belgium

Location

MeSH Terms

Conditions

Lipid Metabolism, Inborn Errors

Condition Hierarchy (Ancestors)

Metabolism, Inborn ErrorsGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesLipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Nurse

Study Record Dates

First Submitted

January 20, 2016

First Posted

March 14, 2016

Study Start

June 1, 2016

Primary Completion

February 1, 2017

Study Completion

February 1, 2017

Last Updated

March 15, 2016

Record last verified: 2016-03

Locations

BE(1)