HDL Acute Lipid Optimization in Homozygous Familial Hypercholesterolemia
1 other identifier
interventional
6
1 country
1
Brief Summary
Assess the effect on coronary atheroma of serial infusions of autologous selectively delipidated HDL/preβ enriched plasma following use of HDL Therapeutics PDS-2™ System
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jan 2018
1 active site
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
April 26, 2017
CompletedFirst Posted
Study publicly available on registry
May 1, 2017
CompletedStudy Start
First participant enrolled
January 26, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 7, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2019
CompletedMay 23, 2019
May 1, 2019
12 months
April 26, 2017
May 21, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
Change in coronary atheroma
Assessed by coronary imaging in study coronary artery segments following serial infusions of autologous selectively delipidated HDL/preβ enriched plasma following use of HDL Therapeutics PDS-2™ System as compared to baseline
2 months
Study Arms (1)
HDL Therapeutics PDS-2™ System
EXPERIMENTALSerial infusions of autologous selectively delipidated HDL/preβ enriched plasma following use of HDL Therapeutics PDS-2™ System
Interventions
Delipidation of plasma HDL to reduce coronary atheroma
Eligibility Criteria
You may qualify if:
- Clinical diagnosis of Homozygous Familial Hypercholesterolemia (HoFH) due to a defect in the LDL receptor, or the identification of a defect in apoB-100, or a gain of function of PCSK9, or a genetic defect resulting in the HoFH clinical phenotype
- No other condition that would preclude the subject from successfully completing the series of plasmapheresis visits in the investigator's opinion
- At least one (1) coronary artery study segment will be identified for each subject and all will remain constant throughout the study. The qualifying study segment(s) will have 20% to 40% stenosis.
You may not qualify if:
- Planned change in current lipid lowering therapy
- Use of oral anticoagulants, unless the dose has been stable for 4 weeks
- LDL or plasma apheresis within 1 week prior to enrollment and through 8-week primary endpoint
- New York Heart Association (NYHA) class III or IV or last known left ventricular ejection fraction \< 30%
- Myocardial infarction, unstable angina, percutaneous coronary intervention (PCI), coronary artery bypass graft (CABG) or stroke within 3 months of enrollment
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- HDL Therapeuticslead
- MedStar Heart and Vascular Institutecollaborator
Study Sites (1)
Cedars-Sinai Medical Center (CSMC)
Los Angeles, California, 90048, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 26, 2017
First Posted
May 1, 2017
Study Start
January 26, 2018
Primary Completion
January 7, 2019
Study Completion
August 1, 2019
Last Updated
May 23, 2019
Record last verified: 2019-05
Data Sharing
- IPD Sharing
- Will not share