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HDL Acute Lipid Optimization in Homozygous Familial Hypercholesterolemia

Sponsor
HDL Therapeutics (Industry)
Overall Status
Unknown status
CT.gov ID
NCT03135184
Collaborator
MedStar Heart and Vascular Institute (Other)
6
Enrollment
1
Location
1
Arm
18.1
Anticipated Duration (Months)
0.3
Patients Per Site Per Month

Study Details

Study Description

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
  • Device: HDL Therapeutics PDS-2 System
 N/A

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

Study Type:
Interventional
Actual Enrollment :
6 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Intervention Model Description:
Prospective, unblinded, interventional studyProspective, unblinded, interventional study
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
HDL Acute Lipid Optimization in Homozygous Familial Hypercholesterolemia
Actual Study Start Date :
Jan 26, 2018
Actual Primary Completion Date :
Jan 7, 2019
Anticipated Study Completion Date :
Aug 1, 2019

Arms and Interventions

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

Primary Outcome Measures

  1. Change in coronary atheroma [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

Criteria

Ages Eligible for Study:
12 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Locations

Site City State Country Postal Code
1 Cedars-Sinai Medical Center (CSMC) Los Angeles California United States 90048

Sponsors and Collaborators

  • HDL Therapeutics
  • MedStar Heart and Vascular Institute

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
HDL Therapeutics
ClinicalTrials.gov Identifier:
NCT03135184
Other Study ID Numbers:
  • HALO-FH
First Posted:
May 1, 2017
Last Update Posted:
May 23, 2019
Last Verified:
May 1, 2019
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
Yes
Additional relevant MeSH terms:
Hyperlipoproteinemia Type II
Hypercholesterolemia
Coal Tar

Study Results

No Results Posted as of May 23, 2019