HDL Acute Lipid Optimization in Homozygous Familial Hypercholesterolemia

Homozygous Familial Hypercholesterolemia Clinical Trial

Official title:

HDL Acute Lipid Optimization in Homozygous Familial Hypercholesterolemia

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03135184
• Other study ID #: HALO-FH
• Status: Active, not recruiting
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• HoFH
• Homozygous Familial Hypercholesterolemia
• Hypercholesterolemia
• Hyperlipoproteinemia Type II

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