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NCT03399786 · ClinicalTrials.gov registry record · Phase 3
Efficacy and Safety of Evinacumab in Patients With Homozygous Familial Hypercholesterolemia
A Phase 3 study, sponsored by Regeneron Pharmaceuticals.
- Completed
- Registry status
- Phase 3
- Development phase
- 65
- Enrollment target
NCT03399786 is a Phase 3 study that has completed, run by Regeneron Pharmaceuticals. The registered enrollment target is 65 participants.
The verdict
NCT03399786, a Phase 3 study, has completed, sponsored by Regeneron Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 65 participants
- Enrollment target
Study Summary
The primary objective of the study is to demonstrate the reduction of low-density lipoprotein cholesterol (LDL-C) by evinacumab intravenously (IV) in comparison to placebo after 24 weeks in patients with homozygous familial hypercholesterolemia (HoFH). The secondary objectives of the study are to evaluate the effect of evinacumab IV on other lipid parameters, evaluate the effect of evinacumab on LDL-C goal attainment, assess the effect of evinacumab on eligibility for apheresis (using German and US apheresis criteria), evaluate the safety and tolerability of evinacumab in patients with HoFH, assess the pharmacokinetics (PK) of evinacumab in patients with HoFH and evaluate the potential development of anti-evinacumab antibodies.
Interventions
- DRUG Placebo
- DRUG evinacumab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 65 participants |
| Start Date | 2018-01-18 |
| Est. Completion | 2020-03-17 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03399786
The ClinicalTrials.gov registry entry for NCT03399786 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 65 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 2 interventions - of which Placebo is the first listed.
NCT03399786 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03399786 about?
NCT03399786 is a clinical study titled "Efficacy and Safety of Evinacumab in Patients With Homozygous Familial Hypercholesterolemia". The primary objective of the study is to demonstrate the reduction of low-density lipoprotein cholesterol (LDL-C) by evinacumab intravenously (IV) in comparison to placebo after 24 weeks in patients with homozygous familial hypercholesterolemia (HoFH). The secondary objectives of the study are to ev...
What is the current status of trial NCT03399786?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 65 participants. The study started on 2018-01-18. Estimated completion is 2020-03-17.
What interventions are being tested in trial NCT03399786?
The interventions under investigation include: Placebo (DRUG), evinacumab (DRUG).
Who is sponsoring clinical trial NCT03399786?
This trial is sponsored by Regeneron Pharmaceuticals, which has 280 total clinical trials registered on ClinicalTrials.gov.
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