Evinacumab
DrugIntravenous (IV) administration
Other names: REGN1500, EVKEEZA®
NCT Number: NCT03409744
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
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Notify Me12 year and older
All sexes
Interventional
Phase 3
Clinical Trial Site, Camperdown, New South Wales, Australia
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Key Inclusion Criteria:
Key Exclusion Criteria:
Note: Other protocol defined Inclusion/Exclusion criteria apply
Intravenous (IV) administration
Other names: REGN1500, EVKEEZA®
Time frame: Up to 216 weeks
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.
Time frame: Up to 120 weeks
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.
Time frame: Up to 120 weeks
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.
Time frame: Up to 120 weeks
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.
Time frame: Up to 120 weeks
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.
Time frame: Up to 120 weeks
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.
Time frame: Up to 120 weeks
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.
Time frame: Up to 120 weeks
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.
Time frame: Up to 120 weeks
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.
Time frame: Up to 120 weeks
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.
Time frame: Up to 120 weeks
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.
Regeneron Pharmaceuticals
Industry
An Open-Label Study to Evaluate the Long-Term Safety and Efficacy of Evinacumab in Patients With Homozygous Familial Hypercholesterolemia
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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