Trial Assessing Long Term USe of PCSK9 Inhibition in Subjects With Genetic LDL Disorders

Conditions

• Severe Familial Hypercholesterolemia

Eligibility Criteria

Sex

ALL

Age

12 Years - 80 Years

Healthy Volunteers

Not accepted

Interventions

• Evolocumab — BIOLOGICAL
  Evolocumab was administered by subcutaneous injection either once a month (QM) or once every two weeks (Q2W).

Study Details

A study to assess the long term safety and tolerability of evolocumab (AMG 145) in adolescents and adults with severe familial hypercholesterolemia.

Key Dates

Start date

Jun 1, 2012

Status verified

May 2024

Primary completion

May 11, 2018

Completion

May 11, 2018

Study Design

Enrollment

300 participants (actual)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: Evolocumab
  Participants received 420 mg evolocumab every month (participants not on lipid apheresis) or every 2 weeks (participants on lipid apheresis) for up to 5 years. Participants could switch dosing regimens at week 12 or 24 based on LDL-C and serum unbound proprotein convertase subtilisin/kexin type 9 (PCSK9) levels.

Primary Outcome Measure

Number of Participants With Adverse Events [ Time Frame: From first dose of study drug in Study 20110271 up to 30 days after the last dose or until the end of study date, whichever was earlier; median duration of treatment was 48.7 months. ]

Locations (6)

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