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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT03135184
Other study ID # HALO-FH
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date January 26, 2018
Est. completion date August 2019

Study information

Verified date May 2019
Source HDL Therapeutics
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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


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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 6
Est. completion date August 2019
Est. primary completion date January 7, 2019
Accepts healthy volunteers No
Gender All
Age group 12 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Device:
HDL Therapeutics PDS-2 System
Delipidation of plasma HDL to reduce coronary atheroma

Locations

Country Name City State
United States Cedars-Sinai Medical Center (CSMC) Los Angeles California

Sponsors (2)

Lead Sponsor Collaborator
HDL Therapeutics MedStar Heart and Vascular Institute

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change in coronary atheroma Assessed by coronary imaging in study coronary artery segments following serial infusions of autologous selectively delipidated HDL/preß enriched plasma following use of HDL Therapeutics PDS-2™ System as compared to baseline 2 months
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