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NCT04233918 · ClinicalTrials.gov registry record · Phase 3
Evaluate the Efficacy and Safety of Evinacumab in Pediatric Patients With Homozygous Familial Hypercholesterolemia
A Phase 3 study, sponsored by Regeneron Pharmaceuticals.
- Completed
- Registry status
- Phase 3
- Development phase
- 20
- Enrollment target
NCT04233918 is a Phase 3 study that has completed, run by Regeneron Pharmaceuticals. The registered enrollment target is 20 participants.
The verdict
NCT04233918, a Phase 3 study, has completed, sponsored by Regeneron Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 20 participants
- Enrollment target
Study Summary
The primary objective for Part A of the study is to assess the pharmacokinetics (PK) of evinacumab in pediatric patients with homozygous familial hypercholesterolemia (HoFH). The primary objective for Part B of the study is to demonstrate a reduction of low-density lipoprotein cholesterol (LDL-C) by evinacumab in pediatric (5 to 11 years of age) patients with HoFH. The secondary objective for Part A of the study is to evaluate the safety and tolerability of evinacumab administered intravenous (IV) in pediatric patients with HoFH. The secondary objectives for Part B of the study are: * To evaluate the effect of evinacumab on other lipid parameters (ie, apolipoprotein B (Apo B), non-high-density lipoprotein cholesterol (non-HDL-C), total cholesterol (TC), lipoprotein a \[Lp(a)\]) in pediatric patients with HoFH * To evaluate the safety and tolerability of evinacumab administered IV in pediatric patients with HoFH * To assess the PK of evinacumab in pediatric patients with HoFH * To assess the immunogenicity of evinacumab in pediatric patients with HoFH over time * To evaluate patient efficacy by mutation status
Interventions
- DRUG Evinacumab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2020-06-29 |
| Est. Completion | 2023-05-30 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04233918
The ClinicalTrials.gov registry entry for NCT04233918 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 20 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Regeneron Pharmaceuticals, which has 280 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Evinacumab is the first listed.
NCT04233918 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04233918 about?
NCT04233918 is a clinical study titled "Evaluate the Efficacy and Safety of Evinacumab in Pediatric Patients With Homozygous Familial Hypercholesterolemia". The primary objective for Part A of the study is to assess the pharmacokinetics (PK) of evinacumab in pediatric patients with homozygous familial hypercholesterolemia (HoFH). The primary objective for Part B of the study is to demonstrate a reduction of low-density lipoprotein cholesterol (LDL-C) b...
What is the current status of trial NCT04233918?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 20 participants. The study started on 2020-06-29. Estimated completion is 2023-05-30.
What interventions are being tested in trial NCT04233918?
The interventions under investigation include: Evinacumab (DRUG).
Who is sponsoring clinical trial NCT04233918?
This trial is sponsored by Regeneron Pharmaceuticals, which has 280 total clinical trials registered on ClinicalTrials.gov.
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