Familial HypercholesterolemiaPhase 4SecuraNCT00916643
Low-Density Lipoprotein (LDL) Apheresis Using H.E.L.P. Therapy
A Phase 4 study testing HELP Secura (apheresis treatment) in people with Familial Hypercholesterolemia, run by B. Braun Medical Inc..
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Familial Hypercholesterolemia
- What is being tested?
- HELP Secura (apheresis treatment)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 113 participants
- Where
- No sites listed yet
- Study dates
- Dec 1999to Sep 2009
- Phase
- Phase 4
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Presence of any of the following conditions:
- untreated hypothyroidism
- decompensated congestive heart failure
- major arrhythmia
- uncontrolled diabetes mellitus
- any malignancy
Show all 13Show fewer
- 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)
About this study
Official title: Post Marketing Surveillance Study for LDL Apheresis Using H.E.L.P. Therapy
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:
Read more
- 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.
Read the detailed description
H.E.L.P. therapy is indicated for use in treating patients with familial hypercholesterolemia (FH) who have undergone six months of optimal diet and drug therapy and whose LDL-C level remains > 300 mg/dl in the absence of CHD or > 200 mg/dl with documented CHD. These patients are divided into three subgroups of interest:
- Group A: functional hypercholesterolemic homozygotes with LDL-C > 500mg/dl;
- Group B: functional hypercholesterolemic heterozygotes with LDL-C > 300mg/dl;
- Group C: functional hypercholesterolemic heterozygotes with LDL-C > 200mg/dl and documented CHD.
Optimal diet therapy is defined as having received instruction by a trained dietitian in the use of a diet meeting the National Cholesterol Education Program (NCEP) Step 2 criteria (< 30% of calories as fat, < 7% of calories as saturated fat, and < 200 mg of dietary cholesterol per day). Optimal drug therapy is defined as having been tried on at least two separate classes of effective serum LDL-C lowering agents (>15% reduction) as currently available for at least six months. These drugs include hydroxy methyl glutaryl (HMG) CoA reductase inhibitors, fibric acid derivatives, niacin, and anion exchange resins. These agents should be used in combination at maximal doses as tolerated by the patient under the supervision of their treating physician to monitor side effects.
Documented coronary heart disease (CHD) includes documentation of coronary heart disease by coronary angiography or a history of myocardial infarction (MI), coronary artery bypass surgery (CABG), percutaneous transluminal coronary angioplasty (PTCA) or alternative revascularization procedure (e.g., atherectomy or stent), or progressive angina documented by exercise or non-exercise stress test.
The primary criteria for evaluating the safety and effectiveness of the device will be:
- Occurrence of Death
- cardiovascular deaths
- non-cardiovascular deaths
- Occurrence of Cardiovascular Events
- MI - stroke
- unstable angina - transient ischemic attack (TIA)
- congestive heart failure - pulmonary embolism
- arrhythmia - peripheral vascular disease
- hypertension
- Occurrence of Surgical or Non-Surgical Intervention Procedure of the Treatment of Atherosclerotic Cardiovascular Disease (ASCVD) including:
- coronary artery bypass graft (CABG) surgery
- peripheral vascular bypass surgery
- percutaneous transluminal coronary angioplasty (PTCA)
- percutaneous transluminal coronary artery bypass graft angioplasty
- percutaneous transluminal peripheral angioplasty (PTA)
- coronary atherectomy (device)
- coronary artery bypass graft atherectomy (device)
- peripheral atherectomy (device)
- carotid endarterectomy (non-device)
- peripheral endarterectomy (non-device)
- coronary artery laser surgery
- coronary artery bypass graft laser surgery
- peripheral vascular laser surgery
- coronary artery stent placement
- coronary artery bypass graft stent placement
- peripheral vascular stent placement
- repair of atherosclerotic aortic and arterial aneurysms
- limb amputation for ASCVD
- Frequency and severity of CHD Symptoms:
- chest pain (angina),
- shortness of breath
- claudication
- Use of CHD Medications for treatment of:
- angina
- heart failure
- arrhythmias
- hypertension
- hyperlipidemia
- Use of Lipid-Lowering Medications and Other Cardiovascular Medications Concomitantly
- Laboratory Assessments (lipid, lipoprotein, chemistry, and clotting factors)
- Quality of life assessments (SF-36)
- Occurrence of Serious and/or Unanticipated Adverse Events Reported During Treatment (e.g., hypotension, nausea, vomiting, syncope)
- Occurrence of other serious illnesses
- Acute Reduction of LDL-C
- Conditions
- Familial Hypercholesterolemia
- Being tested
- HELP Secura (apheresis treatment)
- Keywords
- Hypercholesterolemia, FH, LDL-C, CHD
- Medical subject headings
- Hyperlipoproteinemia Type II, Hypercholesterolemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HELP Secura (apheresis treatment)Device
Process is described in Arm (above).
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: HELP Secura (apheresis treatment) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurence of Death
The Categories listed in the table are the Adverse Events (or similar) that resulted in death.
Measured: 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.
Measured: Participants were followed for one (1) year following discontinuation of treatment.
Serious Unexpected Adverse Events
Measured: 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.
Measured: Participants were followed for one (1) year following discontinuation of treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2009 (estimated)
- Study startDec 1999
- Primary completionSep 2009
- Study completionSep 2009
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.
- Other trials for Familial 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 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 113 participants (actual)
Sponsor and investigators
- Lead sponsor
- B. Braun Medical Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00916643
- Sponsor's protocol ID
- BBMI_HELP_Secura
- Acronym
- Secura
- Status last verified
- Jan 2014
- First submitted
- 8 Jun 2009
- Last updated
- 2 Apr 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post Marketing Surveillance Study for LDL Apheresis Using H.E.L.P. Therapy
- ClinicalTrials.gov ID
- NCT00916643
- Acronym / sponsor ID
- Secura / BBMI_HELP_Secura
- Conditions
- Familial Hypercholesterolemia
- Keywords
- Hypercholesterolemia, FH, LDL-C, CHD
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 113 participants (actual)
- Lead sponsor
- B. Braun Medical Inc.Industry (pharma, biotech, devices)
- Study start
- Dec 1999
- Primary completion
- Sep 2009 (actual)
- Study completion
- Sep 2009 (actual)
- First posted
- 9 Jun 2009 (estimated)
- Results
- Posted 29 Jan 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
H.E.L.P. therapy is indicated for use in treating patients with familial hypercholesterolemia (FH) who have undergone six months of optimal diet and drug therapy and whose LDL-C level remains > 300 mg/dl in the absence of CHD or > 200 mg/dl with documented CHD. These patients are divided into three subgroups of interest:
- Group A: functional hypercholesterolemic homozygotes with LDL-C > 500mg/dl;
- Group B: functional hypercholesterolemic heterozygotes with LDL-C > 300mg/dl;
- Group C: functional hypercholesterolemic heterozygotes with LDL-C > 200mg/dl and documented CHD.
Optimal diet therapy is defined as having received instruction by a trained dietitian in the use of a diet meeting the National Cholesterol Education Program (NCEP) Step 2 criteria (< 30% of calories as fat, < 7% of calories as saturated fat, and < 200 mg of dietary cholesterol per day). Optimal drug therapy is defined as having been tried on at least two separate classes of effective serum LDL-C lowering agents (>15% reduction) as currently available for at least six months. These drugs include hydroxy methyl glutaryl (HMG) CoA reductase inhibitors, fibric acid derivatives, niacin, and anion exchange resins. These agents should be used in combination at maximal doses as tolerated by the patient under the supervision of their treating physician to monitor side effects.
Documented coronary heart disease (CHD) includes documentation of coronary heart disease by coronary angiography or a history of myocardial infarction (MI), coronary artery bypass surgery (CABG), percutaneous transluminal coronary angioplasty (PTCA) or alternative revascularization procedure (e.g., atherectomy or stent), or progressive angina documented by exercise or non-exercise stress test.
The primary criteria for evaluating the safety and effectiveness of the device will be:
- Occurrence of Death
- cardiovascular deaths
- non-cardiovascular deaths
- Occurrence of Cardiovascular Events
- MI - stroke
- unstable angina - transient ischemic attack (TIA)
- congestive heart failure - pulmonary embolism
- arrhythmia - peripheral vascular disease
- hypertension
- Occurrence of Surgical or Non-Surgical Intervention Procedure of the Treatment of Atherosclerotic Cardiovascular Disease (ASCVD) including:
- coronary artery bypass graft (CABG) surgery
- peripheral vascular bypass surgery
- percutaneous transluminal coronary angioplasty (PTCA)
- percutaneous transluminal coronary artery bypass graft angioplasty
- percutaneous transluminal peripheral angioplasty (PTA)
- coronary atherectomy (device)
- coronary artery bypass graft atherectomy (device)
- peripheral atherectomy (device)
- carotid endarterectomy (non-device)
- peripheral endarterectomy (non-device)
- coronary artery laser surgery
- coronary artery bypass graft laser surgery
- peripheral vascular laser surgery
- coronary artery stent placement
- coronary artery bypass graft stent placement
- peripheral vascular stent placement
- repair of atherosclerotic aortic and arterial aneurysms
- limb amputation for ASCVD
- Frequency and severity of CHD Symptoms:
- chest pain (angina),
- shortness of breath
- claudication
- Use of CHD Medications for treatment of:
- angina
- heart failure
- arrhythmias
- hypertension
- hyperlipidemia
- Use of Lipid-Lowering Medications and Other Cardiovascular Medications Concomitantly
- Laboratory Assessments (lipid, lipoprotein, chemistry, and clotting factors)
- Quality of life assessments (SF-36)
- Occurrence of Serious and/or Unanticipated Adverse Events Reported During Treatment (e.g., hypotension, nausea, vomiting, syncope)
- Occurrence of other serious illnesses
- Acute Reduction of LDL-C
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| H.E.L.P. Secura | Experimental | Device: HELP Secura (apheresis treatment)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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Adequate venous access
- Laboratory values:
- 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
Key exclusion criteria (13 listed)
- Presence of any of the following conditions:
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 |
|---|---|---|
| HELP Secura (apheresis treatment)Process is described in Arm (above). | Device | H.E.L.P. Secura |
Primary outcome
Occurence of Death
Time frame: Participants were followed for one (1) year following discontinuation of treatment.
The Categories listed in the table are the Adverse Events (or similar) that resulted in death.
Occurrence of Cardiovascular Events and Interventions
Time frame: Participants were followed for one (1) year following discontinuation of treatment.
Adverse Events reported for Cardiovascular disease not directly related to therapy.
Serious Unexpected Adverse Events
Time frame: Participants were followed for one (1) year following discontinuation of treatment.
Frequency and Severity of CHD Symptoms (Angina)
Time frame: Participants were followed for one (1) year following discontinuation of treatment.
This is equatable to the incidence of Cardiovascular AEs.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing HELP Secura (apheresis treatment) in people with Familial Hypercholesterolemia, run by B. Braun Medical Inc..
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 6 inclusion and 13 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 2 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 29 Jan 2014). 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?
Occurence of Death (time frame: Participants were followed for one (1) year following discontinuation of treatment.). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2 Apr 2024.