Phase 3
Completed N=39
Evolocumab Compared to LDL-C Apheresis in Patients Receiving LDL-C Apheresis Prior to Study Enrollment
Source: ClinicalTrials.gov NCT02585895 ↗Enrolled (actual)
39
Serious AEs
5.1%
Results posted
Sep 2017
Primary outcomePrimary: Percentage of Participants With Apheresis Avoidance at the End of Randomized Therapy — 10.0; 84.2 percentage of participants — p=< 0.0001
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
Summary
To evaluate the efficacy of subcutaneous (SC) evolocumab, compared to regularly scheduled low-density lipoprotein cholesterol (LDL-C) apheresis, on reducing the need for future apheresis.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Apheresis Avoidance at the End of Randomized Therapy |
10.0; 84.2 | < 0.0001 sig |
| SECONDARY Percent Change From Baseline in Low-density Lipoprotein Cholesterol |
2.61; -50.13 | < 0.0001 sig |
| SECONDARY Percent Change From Baseline in Non-high-density Lipoprotein-Cholesterol |
1.80; -44.58 | < 0.0001 sig |
| SECONDARY Percent Change From Baseline in Total Cholesterol/High-density Lipoprotein Cholesterol Ratio |
0.15; -35.65 | < 0.0001 sig |
Eligibility Criteria
Inclusion Criteria
- Male or female, ≥ 18 years of age
- Subject has been receiving regular apheresis for LDL-C lowering for at least 3 months immediately prior to lipid screening and has a treatment goal of LDL-C < 100 mg/dL (2.6 mmol/L), and has been receiving LDL-C apheresis during the last ≥ 4 weeks prior to lipid screening at regular QW or Q2W schedule and with no changes in apheresis type
- Subject is receiving lipid-lowering pharmacological background therapy which includes a high-intensity statin dose (moderate-intensity statin dose with attestation that a higher dose is not appropriate for the subject) unless the subject has a history of statin intolerance
- Lipid-lowering therapy status (ie, any therapy for lowering lipids, including apheresis type and frequency) must be unchanged for ≥ 4 weeks prior to LDL-C screening
- Pre-apheresis LDL-C is ≥ 100 mg/dL (≥ 2.6 mmol/L) and ≤ 190 mg/dL (≤ 4.9 mmol/L) at screening
- Fasting triglycerides ≤ 400 mg/dL (4.5 mmol/L) at screening.
Exclusion criteria
- Known homozygous familial hypercholesterolemia
- Missing any apheresis session is medically contraindicated or inappropriate
- Stopping apheresis would be inappropriate in the opinion of the investigator even if LDL-C is controlled to < 100 mg/dL with other therapies
- Myocardial infarction, unstable angina, percutaneous coronary intervention (PCI), coronary artery bypass graft (CABG) or stroke within 3 months prior to randomization.
- Uncontrolled hypertension
Data sourced from ClinicalTrials.gov (NCT02585895). 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. Informational only — not medical advice.