Low-Density Lipoprotein (LDL) Apheresis Using H.E.L.P. Therapy

NCT00916643 | Completed Phase 4 Results

• 1 other identifier: BBMI_HELP_Secura
• Study Type: interventional
• Target: 113
• Locations: 0 countries
• Sites: N/A

Brief Summary

The objectives of this post-surveillance study are to continue to evaluate the safety and effectiveness of the H.E.L.P. System. The safety and effectiveness will be assessed by evaluating the occurrence of death, cardiovascular events or interventions, angina, and serious unanticipated adverse effects. Laboratory assessments will be made to document low-density lipoprotein cholesterol (LDL-C) reduction and any effects on other blood components. Quality of life assessments will also be made. The study will also assess the modifications to the H.E.L.P. System, including:

• use of a single heparin adsorber, instead of two smaller adsorbers;
• change in the supplier of the ultrafilter (from Secon to Toray);
• reduction in the number of blood lines from eleven to nine;
• change from a single-layer to a two-layer precipitate filter. The safety and efficacy of the device specific to these modifications will be evaluated by comparing the safety and efficacy data from the patient registry to the data from the initial clinical study on the device as originally designed.

Conditions

Familial Hypercholesterolemia

Keywords

Hypercholesterolemia; FH; LDL-C; CHD

Outcome Measures

Primary Outcomes (4)

• Occurence of Death

  The Categories listed in the table are the Adverse Events (or similar) that resulted in death.

  Participants were followed for one (1) year following discontinuation of treatment.

• Occurrence of Cardiovascular Events and Interventions

  Adverse Events reported for Cardiovascular disease not directly related to therapy.

  Participants were followed for one (1) year following discontinuation of treatment.

• Serious Unexpected Adverse Events

  Participants were followed for one (1) year following discontinuation of treatment.

• Frequency and Severity of CHD Symptoms (Angina)

  This is equatable to the incidence of Cardiovascular AEs.

  Participants were followed for one (1) year following discontinuation of treatment.

Study Arms (1)

H.E.L.P. Secura

EXPERIMENTAL

The H.E.L.P. System is a device composed of multiple modules and their associated disposables which can selectively and continuously remove LDL-cholesterol from plasma by precipitating the LDL-cholesterol with high concentrations of heparin in an acidic buffer and returning the plasma to the patient. Procedure steps: 1. Flushing the system with normal saline. 2. Filtering whole blood through a 0.2 micron plasma filter for continuous plasma removal. 3. Mixing the plasma with an equal volume of acetate buffer containing heparin. 4. Precipitation of LDL as a complex with heparin. 5. Removing the LDL-heparin precipitate by continuous circulation through a filter. 6. Removing heparin with use of a heparin adsorber. 7. Bicarbonate dialysis and ultrafiltration to produce an LDL-free plasma without excess heparin. 8. Re-mixing the LDL-free plasma with blood coming from the plasma filter and returning the reconstituted blood to the patient.

Device: HELP Secura (apheresis treatment)

Interventions

HELP Secura (apheresis treatment) DEVICE

Process is described in Arm (above).

H.E.L.P. Secura

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adequate venous access
• Laboratory values:
• Hematocrit 30% or greater
• platelet count between 100,000 and 1,000,000/ml
• Premenopausal women must be surgically sterilized or be on oral contraceptive therapy and have a negative pregnancy test at the onset of treatment with H.E.L.P.
• Patients have familial hypercholesterolemia and have undergone at least 6 months optimal diet and drug therapy and fit group A, B, or C

You may not qualify if:

• Presence of any of the following conditions:
• untreated hypothyroidism
• decompensated congestive heart failure
• major arrhythmia
• uncontrolled diabetes mellitus
• any malignancy
• disorders associated with excessive bleeding (e.g., peptic ulcer and hemophilia)
• established or suspected intracranial disease which might cause intracranial bleeding if the patient is anticoagulated
• any other medical disorders which lead the treating physician to believe that H.E.L.P. treatment would not be in the best interest of the patient
• current treatment with anticoagulants
• diastolic BP \> 100 mmHg recorded in two occasions at least 24 hours apart.
• patients under 18 years of age
• positive test for Hepatitis \[Type A (IgM) or B\] antigen, Hepatitis C antibody, or HIV (or diagnosis of AIDS)

Sponsors & Collaborators

• B. Braun Medical Inc.: lead

MeSH Terms

Conditions

Hyperlipoproteinemia Type II; Hypercholesterolemia

Condition Hierarchy (Ancestors)

Lipid Metabolism, Inborn Errors; Metabolism, Inborn Errors; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Hyperlipoproteinemias; Hyperlipidemias; Dyslipidemias; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Results Point of Contact

• Title: Kevin Minnich
• Organization: B. Braun Medical, Inc.

kevin.minnich@bbraun.com

610 596 2358

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 8, 2009
• First Posted: June 9, 2009
• Study Start: December 1, 1999
• Primary Completion: September 1, 2009
• Study Completion: September 1, 2009
• Last Updated: April 2, 2024
• Results First Posted: January 29, 2014

Record last verified: 2014-01