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NCT03156621 · ClinicalTrials.gov registry record · Phase 3
Study in Participants With Homozygous Familial Hypercholesterolemia (HoFH)
A Phase 3 study of Homozygous Familial Hypercholesterolemia, sponsored by Regeneron Pharmaceuticals.
- Completed
- Registry status
- Phase 3
- Development phase
- 69
- Enrollment target
- 20
- Study locations
NCT03156621: Completed Phase 3 study of Homozygous Familial Hypercholesterolemia, sponsored by Regeneron Pharmaceuticals.
NCT03156621 is a Phase 3 study of Homozygous Familial Hypercholesterolemia that has completed, run by Regeneron Pharmaceuticals. The registered enrollment target is 69 participants, below the 241-participant average among 6 other Homozygous Familial Hypercholesterolemia trials with a reported enrollment target (71% lower). The trial reports 20 study locations across 12 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03156621, a Phase 3 study of Homozygous Familial Hypercholesterolemia, has completed, sponsored by Regeneron Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 69 participants
- Enrollment target
- 20
- Study locations
Study Summary
The primary objective of the study is to demonstrate the reduction of low-density lipoprotein cholesterol (LDL-C) with alirocumab subcutaneous (SC) every 2 weeks (Q2W) in comparison to placebo after 12 weeks of treatment. The secondary objectives of the study are: * To evaluate the effect of alirocumab Q2W on other lipid parameters (ie, apolipoprotein \[Apo\] A-1 and B, non-high-density lipoprotein cholesterol \[non-HDL-C\], total-cholesterol \[TC\], proportion of participants with 15%, 30%, and 50% LDL-C reductions, Lp(a), HDL-C, triglycerides \[TG\]) in participants with HoFH * To evaluate the safety and tolerability of alirocumab SC Q2W in participants with HoFH * To assess the pharmacokinetics of alirocumab SC Q2W in participants with HoFH * To assess the potential development of anti-drug (alirocumab) antibodies
Primary Outcome
The percent change in LDL-C from baseline to week 12 is defined as: 100x (LDL-C value at week 12 - LDL-C value at baseline) / LDL-C value at baseline.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Alirocumab
Study Locations (20)
Other
- Regeneron Research Site - Prague
- Regeneron Research Site - Marseille
- Regeneron Research Site - Paris
- Regeneron Research Site - Berlin
- Regeneron Research Site - Athens
- Regeneron Research Site - Ioannina
- Regeneron Research Site - Naples
- Regeneron Research Site - Roma
Quebec
- Regeneron Research Site - Chicoutimi
- Regeneron Research Site - Québec
Florida
- Regeneron Research Site - Boca Raton
New York
- Regeneron Research Site - New York
Ohio
- Regeneron Research Site - Cincinnati
Texas
- Regeneron Study Site - Dallas
Tyrol
- Regeneron Research Site - Innsbruck
Hyōgo
- Regeneron Research Site - Nishinomiya
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 69 participants |
| Start Date | 2017-10-03 |
| Est. Completion | 2020-02-13 |
| Phase | Phase 3 |
What the finished NCT03156621 record still lists
NCT03156621 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 69 participants, a relatively small participant target, below the 241-participant average among 6 other Homozygous Familial Hypercholesterolemia trials with a reported enrollment target (71% lower).
The record links to 1 condition, with Homozygous Familial Hypercholesterolemia appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT03156621 names 20 study sites across 12 states, led by Other, Quebec, Florida.
Frequently Asked Questions
What is clinical trial NCT03156621 about?
NCT03156621 is a clinical study titled "Study in Participants With Homozygous Familial Hypercholesterolemia (HoFH)". The primary objective of the study is to demonstrate the reduction of low-density lipoprotein cholesterol (LDL-C) with alirocumab subcutaneous (SC) every 2 weeks (Q2W) in comparison to placebo after 12 weeks of treatment. The secondary objectives of the study are: * To evaluate the effect of aliro...
What is the current status of trial NCT03156621?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 69 participants. The study started on 2017-10-03. Estimated completion is 2020-02-13.
What conditions does trial NCT03156621 study?
This clinical trial studies the following conditions: Homozygous Familial Hypercholesterolemia.
What interventions are being tested in trial NCT03156621?
The interventions under investigation include: Placebo (DRUG), Alirocumab (DRUG).
Who is sponsoring clinical trial NCT03156621?
This trial is sponsored by Regeneron Pharmaceuticals, which has 280 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03156621 being conducted?
This trial has 20 study locations across Florida, New York, Ohio, Texas, Tyrol. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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