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Evinacumab for Hypercholesterolemia
Study Summary
This trial will assess the pharmacokinetics, safety, and efficacy of evinacumab in children with homozygous familial hypercholesterolemia.
- Familial Hypercholesterolemia
Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Side effects data
From 2023 Phase 3 trial • 20 Patients • NCT04233918Trial Design
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Who is running the clinical trial?
Frequently Asked Questions
Are there any specific qualifications that make an individual ideal for this research project?
"20 young patients with homozygous familial hypercholesterolemia are needed for this clinical trial. Candidates between the ages of 5 and 11 years old who meet the following requirements are eligible to apply: Body weight ≥15 kg, Receiving stable maximally tolerated therapy*at the screening visit *Maximally tolerated therapy could include a daily statin., Willing and able to comply with clinic visits and study-related procedures."
Has Evinacumab been cleared by the FDA?
"There is both anecdotal evidence and clinical data supporting Evinacumab's safety, so it received a score of 3."
What are scientists and doctors hoping to learn from this clinical trial?
"The main metric that will be used to gauge the success of this medical intervention over the course of 24 weeks is the area under the concentration-time curve (AUC). Additionally,secondary outcomes like the percent change in total cholesterol (TC) from baseline to week 24, the proportion of patients with ≥50% reduction in calculated LDL-C at week 24, and the absolute change in LDL-C at week 24 will be used to supplement the primary outcome."
What other research studies have included Evinacumab as a testing drug?
"Evinacumab is being trialed in 92 locations, with 3 of those trials currently active. Out of the three, 2 are in Phase 3."
Does this research study hope to enroll participants who are over 45 years old?
"Children aged 5 to 11 may be eligible for this clinical trial, as indicated by the inclusion criteria. Out of the 72 total studies, 14 are for patients under 18 years old and 58 are for patients over 65."
What earlier research has been conducted in this area?
"Evinacumab has been under investigation since 2018 when the first study, sponsored by Regeneron Pharmaceuticals, was completed with 116 participants. Evinacumab received Phase 3 drug approval after this initial study. Currently, there are 3 active studies involving Evinacumab being conducted in 57 cities spanning 14 countries."
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