Phase 4
N=113
Low-Density Lipoprotein (LDL) Apheresis Using H.E.L.P. Therapy
Familial Hypercholesterolemia
Bottom Line
View on ClinicalTrials.gov: NCT00916643 ↗Enrolled (actual)
113
Serious AEs
8.0%
Results posted
Jan 2014
Primary outcome: Primary: Occurence of Death — 1; 1; 1; 1 participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- HELP Secura (apheresis treatment) (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- B. Braun Medical Inc.
- Primary completion
- Sep 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Occurence of Death |
1; 1; 1; 1 | — |
| PRIMARY Occurrence of Cardiovascular Events and Interventions |
16; 9 | — |
| PRIMARY Serious Unexpected Adverse Events |
— | — |
| PRIMARY Frequency and Severity of CHD Symptoms (Angina) |
23 | — |
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.
Eligibility Criteria
Inclusion Criteria
- 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
Exclusion Criteria
- 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)
Data sourced from ClinicalTrials.gov (NCT00916643). 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.