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NCT03409744 · ClinicalTrials.gov registry record · Phase 3
Evaluate the Long-Term Safety and Efficacy of Evinacumab in Patients With Homozygous Familial Hypercholesterolemia
A Phase 3 study, sponsored by Regeneron Pharmaceuticals.
- Completed
- Registry status
- Phase 3
- Development phase
- 116
- Enrollment target
NCT03409744: Completed Phase 3 study, sponsored by Regeneron Pharmaceuticals.
NCT03409744 is a Phase 3 study that has completed, run by Regeneron Pharmaceuticals. The registered enrollment target is 116 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (85% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03409744, a Phase 3 study, has completed, sponsored by Regeneron Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 116 participants
- Enrollment target
Study Summary
The primary objectives of the study are: * To evaluate the long-term safety and tolerability of evinacumab in patients with Homozygous Familial Hypercholesterolemia (HoFH) * To evaluate the long-term safety and tolerability of evinacumab in adolescent patients with HoFH The secondary objectives of the study are: * To evaluate the effect of evinacumab on lipid parameters in patients with HoFH * To evaluate the effect of evinacumab on lipid parameters in adolescent patients with HoFH * To evaluate the potential development of anti-evinacumab antibodies
Primary Outcome
The safety analysis set (SAF) included all participants who were enrolled and received at least 1 dose or part of a dose of open-label study treatment.
Interventions
- DRUG evinacumab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 116 participants |
| Start Date | 2018-03-13 |
| Est. Completion | 2023-04-13 |
| Phase | Phase 3 |
What the finished NCT03409744 record still lists
NCT03409744 is an interventional study that assigns participants to a tested intervention. The registered 116 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (85% lower).
The record links to 0 conditions, and to 1 intervention - of which evinacumab is the first listed.
NCT03409744 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03409744 about?
NCT03409744 is a clinical study titled "Evaluate the Long-Term Safety and Efficacy of Evinacumab in Patients With Homozygous Familial Hypercholesterolemia". The primary objectives of the study are: * To evaluate the long-term safety and tolerability of evinacumab in patients with Homozygous Familial Hypercholesterolemia (HoFH) * To evaluate the long-term safety and tolerability of evinacumab in adolescent patients with HoFH The secondary objectives of...
What is the current status of trial NCT03409744?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 116 participants. The study started on 2018-03-13. Estimated completion is 2023-04-13.
What interventions are being tested in trial NCT03409744?
The interventions under investigation include: evinacumab (DRUG).
Who is sponsoring clinical trial NCT03409744?
This trial is sponsored by Regeneron Pharmaceuticals, which has 280 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03409744's enrollment target sits among peer trials
116 1643rd of 2000 higher than 357 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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