N/A
N=18
(H.E.L.P.)Apheresis Therapy to Compare the Reduction of LDL (Low Density Lipoprotein) Cholesterol
Hypercholesterolemia
Bottom Line
View on ClinicalTrials.gov: NCT00526058 ↗Enrolled (actual)
18
Serious AEs
13.9%
Results posted
Jul 2010
Primary outcome: Primary: 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. — 55.28; 52.89 percent change
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Secura then Futura (Device); Futura then Secura (Device)
- Age
- Adult, Older Adult · 25+ yrs
- Sex
- All
- Sponsor
- B. Braun Medical Inc.
- Primary completion
- Oct 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 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. |
55.28; 52.89 | — |
| PRIMARY Percent Change of the Pre and Post Treatment Value |
55.28; 52.89 | 0.005 sig |
| SECONDARY Clinical Lab Profiles (Pre- and Post-Treatment) |
63.17; 71.46; 50.23; 48.12; 11.82; 7.41 | — |
| SECONDARY Device Parameters |
27.11; 12.39; 23.41; 8.89; 28.00; 9.67 | — |
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.
Eligibility Criteria
Inclusion Criteria
- 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)
Exclusion Criteria
- A History of a known sensitivity to heparin or ethylene oxide.
- A history of hemorrhagic diathesis, bleeding/clotting disorder, thrombocytopenia (defined as platelet count 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 2X upper limit of normal range.
- History of dementia.
- History of anemia (value outside the lower normal range).
- acetyl salicylic acid (ASA) > 325 mg/day.
- Subject currently enrolled in another investigational study (does not apply to PMS for Secura device).
- Subject with any other medical condition that in the opinion of the investigator might put the subject at risk or interfere with his/her participation.
- Subject is unwilling or unable to comply with the protocol or to cooperate fully with the investigator or site personnel.
Data sourced from ClinicalTrials.gov (NCT00526058). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.