Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 1:59 PM
Ignite Modification Date:
2025-12-24 @ 1:59 PM
NCT ID:
NCT02585895
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02585895
Study Brief:
Protocol Section:
NCT02585895