Study of Alirocumab (REGN727/SAR236553) in Patients With Heterozygous Familial Hypercholesterolemia (HeFH) Undergoing Low-density Lipoprotein (LDL) Apheresis Therapy

Overview

Información sobre este estudio

This is a randomized, double-blind, placebo-controlled, parallel-group study to evaluate the effect of alirocumab in comparison with placebo on the frequency of LDL apheresis treatments in patients with HeFH undergoing LDL apheresis therapy.

Elegibilidad para la participación

Los requisitos de elegibilidad de los participantes incluyen la edad, el sexo, el tipo y el estadio de la enfermedad, y los problemas de salud o tratamientos previos. Las pautas difieren de un estudio a otro e identifican quiénes pueden o no pueden participar. No hay garantía de que cada persona elegible que desee participar en un ensayo se inscribirá. Comunícate con el equipo del estudio para analizar la elegibilidad del estudio y la posible participación.

Inclusion Criteria:

  1. Men and women ≥18 years of age at the time of the screening visit
  2. Diagnosis of HeFH (Heterozygous familial hypercholesterolemia)
  3. Currently undergoing LDL (low-density lipoprotein) apheresis therapy QW (weekly) or Q2W (every 2 weeks) or at least 8 weeks prior to the screening visit

Exclusion Criteria:

  1. Homozygous FH (familial hypercholesterolemia)
  2. Background medical LMT (lipid-modifying therapy) (if applicable) that has not been stable for at least 8 weeks prior to the screening visit
  3. LDL apheresis schedule/ apheresis settings that have not been stable for at least 8 weeks prior to the screening visit
  4. An LDL apheresis schedule other than QW to Q2W
  5. Initiation of a new exercise program or exercise that has not remained stable within 8 weeks prior to the screening visit (week -2)
  6. Initiation of a new diet or a diet that has not been stable within 8 weeks prior to the screening visit (week -2)
  7. Use of nutraceuticals or over-the-counter therapies known to affect lipids, at a dose/amount that has not been stable for at least 8 weeks prior to the screening visit (week -2), or between the screening and randomization visit
  8. Presence of any clinically significant uncontrolled endocrine disease known to influence serum lipids or lipoproteins
  9. Known history of a positive test for human immunodeficiency virus
  10. Use of any active investigational drugs within 1 month or 5 half-lives of screening, whichever is longer
  11. Patients who have been treated with at least 1 dose of alirocumab or any other anti-PCSK9 monoclonal antibody in any other clinical studies
  12. Pregnant or breastfeeding women

Sedes participantes de Mayo Clinic

Los estatus de los estudios cambian con frecuencia. Comunícate con el equipo del estudio para obtener la información más actualizada acerca de la posibilidad de participar.

Sede de Mayo Clinic Estatus

Rochester, Minn.

Investigador principal de Mayo Clinic

Vinaya Simha, M.B.B.S., M.D.

Cerrado para la inscripción

More information

Publicaciones

  • To evaluate the effect of alirocumab on frequency of standard apheresis treatments [weekly or every 2 weeks (Q2W)] in heterozygous familial hypercholesterolaemia (HeFH). Read More on PubMed
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CLS-20145688

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