(H.E.L.P.)Apheresis Therapy to Compare the Reduction of LDL (Low Density Lipoprotein) Cholesterol

NCT00526058 | Completed Results

• 1 other identifier: LDLc-A-US2-0406
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 2

Brief Summary

The primary objective of the study is to demonstrate that the performance of the modified Plasmat® Futura H.E.L.P. Apheresis System is non-inferior to the current FDA approved Plasmat® Secura H.E.L.P Apheresis System for use under the approved indication of the acute reduction of LDL-cholesterol from the plasma in populations for whom diet has been ineffective and maximum drug therapy has either been ineffective or not tolerated.

Conditions

Hypercholesterolemia

Keywords

Heparin; Extracorporeal; Low Density Lipo-Protein (LDL) Cholesterol; Apheresis; Device

Outcome Measures

Primary Outcomes (2)

• Percent Change in Pre- and Post-treatment Reductions of Low-density Lipoprotein Cholesterol (LDL-C) Levels Between the Approved H.E.L.P. System and the Modified H.E.L.P. System.

  Blood samples for LDL-cholesterol determination will be obtained before and after each treatment from week 0 to week 24..

• Percent Change of the Pre and Post Treatment Value

  The primary study endpoint is the change in percent measurements of the pre-to-post apheresis LDL measurements. Blood samples for LDL-cholesterol determination will be obtained before and after each treatment. The pooled difference between the pre- and post-treatment LDL level for each apheresis machine will be reported as the primary endpoint for the system performance.

  Assessment based on LDL-C values obtained pre-and post-treatment, analyzed from week 0 to week 24.

Secondary Outcomes (2)

• Clinical Lab Profiles (Pre- and Post-Treatment)

  Analyzed at specific time points throughout the study from week 0 to week 24.

• Device Parameters

  Analyzed at specific time points throughout the study from week 0 to week 24.

Study Arms (2)

A (Secura then Futura)

OTHER

The Group Randomized first to the approved Plasmat® Secura apheresis system and then to the Plasmat® Futura apheresis system.

Device: Secura then Futura

B (Futura then Secura)

OTHER

The Group Randomized first to the approved Plasmat® Futura apheresis system and then to the Plasmat® Secura apheresis system.

Device: Futura then Secura

Interventions

Secura then Futura DEVICE

Randomized to 6 bi-monthly H.E.L.P. therapy treatments with the Plasmat® Secura apheresis system and then cross over to receive 6 bi-monthly treatments with the Plasmat® Futura apheresis system.

A (Secura then Futura)

Futura then Secura DEVICE

Randomized to 6 bi-monthly H.E L.P. therapy treatments with the Plasmat® Futura apheresis system and then cross over to receive 6 bi-monthly treatments with the Plasmat® Secura apheresis system.

B (Futura then Secura)

Eligibility Criteria

• Age: 25 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subject is between 25 and 70 years of age (inclusive) at the time of randomization.
• Subject is an appropriate candidate for H.E.L.P. apheresis treatment for hypercholesterolemia according to current Plasmat® Secura approval criteria.
• Subject has received a minimum of two consecutive bi-monthly\* H.E.L.P. apheresis treatments using the Plasmat® Secura apheresis system \>30 days prior to the screening visit.
• Subject is willing to maintain cholesterol lowering dietary and drug therapies as prescribed through the course of the study.
• Subject is willing and able to provide written informed consent and Health Insurance Portability and Accountability Act (HIPAA) Waiver.
• Sterile, post-menopausal, or using acceptable birth control for the duration of the study. Acceptable birth control is defined as having a vasectomized, postmenopausal, or sterile partner; the ongoing use of approved hormonal contraceptives, barrier method, or an intrauterine device; or abstinence.
• Every 14 days (±2 days)

You may not qualify if:

• A History of a known sensitivity to heparin or ethylene oxide.
• A history of hemorrhagic diathesis, bleeding/clotting disorder, thrombocytopenia (defined as platelet count \< 150 x109/L), or for whom the use of heparin would cause excessive or uncontrolled anticoagulation or for whom adequate anticoagulation cannot be safely achieved (ie., hemophilia, recent surgery, acute internal bleeding, gastrointestinal ulcers).
• Females who are pregnant or lactating.
• Subjects\< 106 lbs. or \<48.2 kg in body weight; or whose weight is \>1.5 times their ideal weight.
• Certain cardiac impairments such as congestive heart failure, major arrhythmia, or diastolic blood pressure greater than 100 mm/Hg on two separate occasions at least 24 hours apart.
• Renal insufficiency defined as creatinine greater \>2.0 mg/dlL or is dependent upon renal dialysis.
• Untreated hypothyroidism; uncontrolled diabetes mellitus; or fasting triglycerides \>500 mg/dL.
• Serious systemic disease (e.g., advanced neoplasms, and acute hepatitis) including Immune system suppression or compromise, that could preclude survival to study completion.
• History of stroke within 6 months of the screening visit.
• Received thrombolytic treatment \< 7 days of screening.visit.
• Taken or requires a prohibited treatment \< 30 days prior to the Screening Visit, or requires a prohibited treatment at anytime during the course of the study.
• Neutropenia (neutrophil count \< 0.5 x109/L).
• History of liver disease or serum ALT and/or AST \> 2X upper limit of normal range.
• History of dementia.
• History of anemia (value outside the lower normal range).

Sponsors & Collaborators

• B. Braun Medical Inc.: lead

Study Sites (2)

Hartford Hospital

Hartford, Connecticut, 06102, United States

Location

University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

Location

Related Publications (4)

• Julius U, Metzler W, Pietzsch J, Fassbender T, Klingel R. Intraindividual comparison of two extracorporeal LDL apheresis methods: lipidfiltration and HELP. Int J Artif Organs. 2002 Dec;25(12):1180-8. doi: 10.1177/039139880202501210.

  PMID: 12518963 BACKGROUND

• Susca M. Heparin-Induced extracorporeal low-density lipoprotein precipitation futura, a new modification of HELP apheresis: technique and first clinical results. Ther Apher. 2001 Oct;5(5):387-93. doi: 10.1046/j.1526-0968.2001.00371.x.

  PMID: 11778925 BACKGROUND

• Schettler V, Monazahian M, Wieland E, Thomssen R, Muller GA. Effect of heparin-induced extracorporeal low-density lipoprotein precipitation (HELP) apheresis on hepatitis C plasma virus load. Ther Apher. 2001 Oct;5(5):384-6. doi: 10.1046/j.1526-0968.2001.00374.x.

  PMID: 11778924 BACKGROUND

• Moriarty PM, Gibson CA, Shih J, Matias MS. C-reactive protein and other markers of inflammation among patients undergoing HELP LDL apheresis. Atherosclerosis. 2001 Oct;158(2):495-8. doi: 10.1016/s0021-9150(01)00633-5.

  PMID: 11583732 BACKGROUND

MeSH Terms

Conditions

Hypercholesterolemia

Condition Hierarchy (Ancestors)

Hyperlipidemias; Dyslipidemias; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Results Point of Contact

• Title: Kevin Minnich, Manager Clinical Affairs/Safety Officer
• Organization: B. Braun Medical Inc.

kevin.minnich@bbraun.com

610-596-2358

Study Officials

• Patrick Moriarty, M.D.

  University of Kansas Medical Center

  PRINCIPAL INVESTIGATOR

• Paul Thompson, M.D.

  Hartford Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 5, 2007
• First Posted: September 6, 2007
• Study Start: August 1, 2007
• Primary Completion: October 1, 2008
• Study Completion: December 1, 2008
• Last Updated: September 14, 2018
• Results First Posted: July 30, 2010

Record last verified: 2018-08

Locations

US (2)