HypercholesterolemiaFUTURANCT00526058
(H.E.L.P.)Apheresis Therapy to Compare the Reduction of LDL (Low Density Lipoprotein) Cholesterol
A study testing Secura then Futura and Futura then Secura in people with Hypercholesterolemia, run by B. Braun Medical Inc. at 2 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 25 to 70 years
- Conditions the study is for
- Hypercholesterolemia
- What is being tested?
- Secura then Futura and Futura then Secura
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 2 sitesUnited States
- Study dates
- Aug 2007to Dec 2008
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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.
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- 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).
- 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.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Hartford Hospital
Hartford, Connecticut, 06102
University of Kansas Medical Center
Kansas City, Kansas, 66160
About this study
Official title: Randomized Multicenter Crossover Study to Compare the Plasmat® Futura Heparin Induced Extracorporeal Lower Density Lipo-Protein (LDL) Precipitation (H.E.L.P.) Apheresis System to the Approved Secura System in the Reduction of LDL-c in Patients With Hypercholesterolemia
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.
Read the detailed description
The primary study endpoint is the change in percent measurements of the pre-to-post apheresis LDL measurements between the approved H.E.L.P. system and the modified H.E.L.P. system. The secondary study endpoints are clinical lab profiles and device parameters analyzed at specific time points throughout the study.
- Conditions
- Hypercholesterolemia
- Being tested
- Secura then Futura, Futura then Secura
- Keywords
- Heparin, Extracorporeal, Low Density Lipo-Protein (LDL) Cholesterol, Apheresis, Device
- Medical subject headings
- Hypercholesterolemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Secura then FuturaDevice
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.
Futura then SecuraDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| A (Secura then Futura) | Other | The Group Randomized first to the approved Plasmat® Secura apheresis system and then to the Plasmat® Futura apheresis system. Receives: 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. Receives: Device: Futura then Secura |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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)
Changes in pre- and post-treatment levels of total cholesterol, high-density lipoprotein cholesterol (HDL-C), total triglycerides, lipoprotein (a), fibrinogen, and C-reactive protein.
Measured: Analyzed at specific time points throughout the study from week 0 to week 24.
Device Parameters
Comparison of plasma flow rate recorded with both systems before treatment, after 500 mL of plasma treated, and at the end of each treatment session.
Measured: Analyzed at specific time points throughout the study from week 0 to week 24.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Sep 2007 (estimated)
- Study startAug 2007
- Primary completionOct 2008
- Study completionDec 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for HypercholesterolemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- B. Braun Medical Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Patrick Moriarty, M.D., Principal investigator, University of Kansas Medical CenterPaul Thompson, M.D., Principal investigator, Hartford Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00526058
- Sponsor's protocol ID
- LDLc-A-US2-0406
- Acronym
- FUTURA
- Status last verified
- Aug 2018
- First submitted
- 5 Sep 2007
- Last updated
- 14 Sep 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
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.
PubMed 12518963Susca 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.
PubMed 11778925Schettler 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.
PubMed 11778924Moriarty 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.
PubMed 11583732
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Multicenter Crossover Study to Compare the Plasmat® Futura Heparin Induced Extracorporeal Lower Density Lipo-Protein (LDL) Precipitation (H.E.L.P.) Apheresis System to the Approved Secura System in the Reduction of LDL-c in Patients With Hypercholesterolemia
- ClinicalTrials.gov ID
- NCT00526058
- Acronym / sponsor ID
- FUTURA / LDLc-A-US2-0406
- Conditions
- Hypercholesterolemia
- Keywords
- Heparin, Extracorporeal, Low Density Lipo-Protein (LDL) Cholesterol, Apheresis, Device
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- B. Braun Medical Inc.Industry (pharma, biotech, devices)
- Study start
- Aug 2007
- Primary completion
- Oct 2008 (actual)
- Study completion
- Dec 2008 (actual)
- First posted
- 6 Sep 2007 (estimated)
- Results
- Posted 30 Jul 2010
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The primary study endpoint is the change in percent measurements of the pre-to-post apheresis LDL measurements between the approved H.E.L.P. system and the modified H.E.L.P. system. The secondary study endpoints are clinical lab profiles and device parameters analyzed at specific time points throughout the study.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A (Secura then Futura) | Other | Device: Secura then FuturaThe Group Randomized first to the approved Plasmat® Secura apheresis system and then to the Plasmat® Futura apheresis system. |
| B (Futura then Secura) | Other | Device: Futura then SecuraThe Group Randomized first to the approved Plasmat® Futura apheresis system and then to the Plasmat® Secura apheresis system. |
Who may qualify
- Ages
- 25 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (19 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Secura then FuturaRandomized 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. | Device | A (Secura then Futura) |
| Futura then SecuraRandomized 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. | Device | B (Futura then Secura) |
Primary outcome
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.
Time frame: 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
Time frame: Assessment based on LDL-C values obtained pre-and post-treatment, analyzed from week 0 to week 24.
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.
2 secondary outcomes
Clinical Lab Profiles (Pre- and Post-Treatment)
Time frame: Analyzed at specific time points throughout the study from week 0 to week 24.
Device Parameters
Time frame: Analyzed at specific time points throughout the study from week 0 to week 24.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 12518963Julius 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.
- Background: PubMed 11778925Susca 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.
- Background: PubMed 11778924Schettler 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.
- Background: PubMed 11583732Moriarty 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Patrick Moriarty, M.D. principal investigator
University of Kansas Medical Center
Paul Thompson, M.D. principal investigator
Hartford Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Secura then Futura and Futura then Secura in people with Hypercholesterolemia, run by B. Braun Medical Inc. at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 30 Jul 2010). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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. (time frame: Blood samples for LDL-cholesterol determination will be obtained before and after each treatment from week 0 to week 24..). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00526058, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Sep 2018; AzTrials last refreshed its copy on 2 Nov 2026.