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HDL Acute Lipid Optimization in Homozygous Familial Hypercholesterolemia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03135184
Recruitment Status : Unknown
Verified May 2019 by HDL Therapeutics.
Recruitment status was:  Active, not recruiting
First Posted : May 1, 2017
Last Update Posted : May 23, 2019
Sponsor:
Collaborator:
MedStar Heart and Vascular Institute
Information provided by (Responsible Party):
HDL Therapeutics

Study Description
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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

Condition or disease Intervention/treatment Phase
Homozygous Familial Hypercholesterolemia HoFH Device: HDL Therapeutics PDS-2 System Not Applicable

Detailed Description:
The PDS-2™ System is intended to reduce coronary atheroma in patients with Homozygous Familial Hypercholesterolemia (HoFH). Subjects will receive serial infusions of autologous selectively delipidated HDL/preβ enriched plasma following use of HDL Therapeutics' PDS-2 System.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 6 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: Prospective, unblinded, interventional study
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: HDL Acute Lipid Optimization in Homozygous Familial Hypercholesterolemia
Actual Study Start Date : January 26, 2018
Actual Primary Completion Date : January 7, 2019
Estimated Study Completion Date : August 2019

Resource links provided by the National Library of Medicine

Drug Information available for: Coal Tar

Arms and Interventions
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Arm Intervention/treatment
Experimental: HDL Therapeutics PDS-2™ System
Serial infusions of autologous selectively delipidated HDL/preβ enriched plasma following use of HDL Therapeutics PDS-2™ System
 Device: HDL Therapeutics PDS-2 System
Delipidation of plasma HDL to reduce coronary atheroma


Outcome Measures
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Primary Outcome Measures :
  1. Change in coronary atheroma [ Time Frame: 2 months ]
    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


Eligibility Criteria
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Ages Eligible for Study:   12 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Key Inclusion Criteria:

  • 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.

Key Exclusion Criteria:

  • 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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03135184


Locations
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United States, California
Cedars-Sinai Medical Center (CSMC)
Los Angeles, California, United States, 90048
Sponsors and Collaborators
HDL Therapeutics
MedStar Heart and Vascular Institute
More Information
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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Responsible Party: HDL Therapeutics
ClinicalTrials.gov Identifier: NCT03135184    
Other Study ID Numbers: HALO-FH
First Posted: May 1, 2017    Key Record Dates
Last Update Posted: May 23, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Additional relevant MeSH terms:
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Hyperlipoproteinemia Type II
Homozygous Familial Hypercholesterolemia
Hypercholesterolemia
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases
 Lipid Metabolism, Inborn Errors
Metabolism, Inborn Errors
Genetic Diseases, Inborn
Hyperlipoproteinemias
Coal Tar
Keratolytic Agents
Dermatologic Agents