Homozygous Familial Hypercholesterolemia
Conditions
Interventions
None listed
Sponsors
Tada Hayato
Tobita Kimimasa
Eligibility
Inclusion criteria
Inclusion criteria: Patients with homozygous familial hypercholesterolemia treated with evinacumab
Exclusion criteria
Exclusion criteria: Patients who did not provide consent to participate in the study, except at institutions that adopted opt-out procedures.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate the incidence and severity of adverse events in patients with homozygous familial hypercholesterolemia (HoFH) receiving intravenous evinacumab (15 mg/kg) every four weeks. Additionally, to assess the efficacy of evinacumab based on changes in LDL cholesterol levels following administration. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Descriptive evaluation of the clinical status of patients treated with evinacumab, including performed examinations, concomitant medications, combination therapies, comorbidities and medical history, and physical findings. 2. Descriptive evaluation of changes in concomitant medications and combination therapies following administration of evinacumab. 3. Descriptive evaluation of changes in cardiovascular lesions (e.g., carotid intima-media thickness [IMT], cardiovascular imaging findings) after evinacumab administration. 4. Descriptive evaluation of changes in clinical laboratory values following evinacumab administration. 5. Descriptive evaluation of changes in xanthomas after evinacumab administration. 6. Descriptive evaluation of the safety and efficacy of evinacumab based on genotype, age, sex, and treatment background. | — |
Countries
Japan, N A
Contacts
Public ContactHayato Tada
Kanazawa University Graduate School of Medical Sciences
Outcome results
None listed