Non-randomized, prospective, non-controlled study of changes of lipid parameters after introduction of evolocumab in patients with heterozygous familial hypercholesterolemia under LDL-apheresis therapy.

Non-randomized, prospective, non-controlled study of changes of lipid parameters after introduction of evolocumab in patients with heterozygous familial hypercholesterolemia under LDL-apheresis therapy. - Impact of evelocumab in homozygous familial hypercholesterolemia under LDL-apheresis.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000022603

Enrollment

Registered

2016-06-04

Start date

2016-06-06

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Homozygous familial hypercholesterolemia

Interventions

Subcutaneous injection of evolocumab

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Homozygous familial hypercholesterolemic patients under LDL-apheresis therapy and stable lipid-lowering therapy including statins, ezetimibe, fibrates, resin, probucol, EPA, niacin, and vitamin E

Exclusion criteria

Exclusion criteria: Myocardial infarction or unstable angina within 8 weeks Severe anemia (Hb <10g/dL) Allergy against evolocumab Immunosupressive therapy Severe hepatic disorder (ASTorALT>100IU/L) Severe renal disorder (BUN>40mg/dL or Cre>2.0mg/dL) (Possible of) pregnancy

Design outcomes

Primary

Measure	Time frame
Comparison of the time constant average levels of LDL-C and apoB before and after evolocumab thereapy.	—

Countries

Japan

Contacts

Public ContactMasa-aki Kawashiri

Kanazawa University Hospital Department of Cardiology

mk@med.kanazawa-u.ac.jp076-265-2251

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026