Long Term Safety Study of PRALUENT

Sponsor:

Collaborators:

Information provided by (Responsible Party):

，

Tracking Information

First Submitted Date ^ICMJE

September 6, 2018

First Posted Date ^ICMJE

October 3, 2018

Last Update Posted Date

October 3, 2018

Actual Study Start Date ^ICMJE

September 28, 2018

Estimated Primary Completion Date

November 24, 2023 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Incidence of adverse events (AEs) after first administration of study drug through the last dose of study drug plus 2 weeks[ Time Frame: Up to week 192 ]

Original Primary Outcome Measures ^ICMJE

Same as current

Current Secondary Outcome Measures ^ICMJE

Calculated low-density lipoprotein cholesterol (LDL-C) values from baseline over time[ Time Frame: Up to week 192 ]
Percent change in LDL-C from baseline over time[ Time Frame: Up to week 192 ]
Total cholesterol (Total-C) values from baseline over time[ Time Frame: Up to week 192 ]
Non-high-density lipoprotein cholesterol (non-HDL-C) values from baseline over time[ Time Frame: Up to week 192 ]
High-density lipoprotein cholesterol (HDL-C) values from baseline over time[ Time Frame: Up to week 192 ]
Triglyceride (TG) values from baseline over time[ Time Frame: Up to week 192 ]
Percent change from baseline in Total-C over time[ Time Frame: Up to week 192 ]
Percent change from baseline in non-HDL-C over time[ Time Frame: Up to week 192 ]
Percent change from baseline in HDL-C over time[ Time Frame: Up to week 192 ]
Percent change from baseline in TGs over time[ Time Frame: Up to week 192 ]
Gonadal hormone values from baseline over time[ Time Frame: Up to week 192 ]
Gonadotropin values from baseline over time[ Time Frame: Up to week 192 ]
Percent change from baseline in gonadal hormones over time[ Time Frame: Up to week 192 ]
Percent change from baseline in gonadotropins over time[ Time Frame: Up to week 192 ]
Alanine transaminase values from baseline over time[ Time Frame: Up to week 192 ]
Aspartate transferase values from baseline over time[ Time Frame: Up to week 192 ]
Alkaline phosphatase values from baseline over time[ Time Frame: Up to week 192 ]
Total bilirubin values from baseline over time[ Time Frame: Up to week 192 ]
Percent change from baseline in alanine transaminase over time[ Time Frame: Up to week 192 ]
Percent change from baseline in aspartate transferase over time[ Time Frame: Up to week 192 ]
Percent change from baseline in alkaline phosphatase over time[ Time Frame: Up to week 192 ]
Percent change from baseline in total bilirubin over time[ Time Frame: Up to week 192 ]

Descriptive Information

Brief Title ^ICMJE

Long Term Safety Study of PRALUENT

Official Title ^ICMJE

Long Term Safety Study of PRALUENT in Patients With Heterozygous Familial Hypercholesterolemia or With Non-Familial Hypercholesterolemia at High and Very High Cardiovascular Risk and Previously Enrolled in the Neurocognitive Function Trial

Brief Summary

The primary objective of the study is to evaluate the long term safety of PRALUENT in participants with heterozygous familial hypercholesterolemia (heFH) or non-familial hypercholesterolemia (FH) patients at high or very high cardiovascular risk who completed the neurocognitive function study (R727-CL-1532: NCT02957682). The secondary objectives of the study are: - To evaluate the effect of PRALUENT on low-density lipoprotein cholesterol (LDL-C) - To evaluate the effect of PRALUENT on other lipid parameters - To evaluate the effect of PRALUENT on gonadal steroid hormones

Detailed Description

Study Type ^ICMJE

Interventional

Study Phase

Phase 4

Study Design ^ICMJE

Allocation:
Intervention Model: Single Group Assignment
Intervention Model Description:
Masking: Interventional
Masking Description:
Primary Purpose: Treatment

Condition ^ICMJE

Intervention ^ICMJE

Drug: Praluent
Subcutaneous (SC) administration

Study Arms

Experimental: Open label

Recruitment Information

Recruitment Status ^ICMJE

Not yet recruiting

Estimated Enrollment ^ICMJE

1600

Original Estimated Enrollment ^ICMJE

Same as current

Estimated Study Completion Date

November 24, 2023

Estimated Primary Completion Date

November 24, 2023 (Final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Key Inclusion Criteria: Participants randomized into the neurocognitive function study (R727-CL-1532) who completed treatment and the end of study (EOS) visit with no premature or permanent discontinuation of study drug. Key Exclusion Criteria: 1. Significant protocol deviation in the parent study (neurocognitive function study, R727-CL-1532: NCT02957682) based on the investigator's or sponsor's judgment, such as noncompliance 2. Any participant who experienced an AE leading to permanent discontinuation from the neurocognitive function study, (R727-CL-1532: NCT02957682). 3. Any new condition or worsening of an existing condition which, in the opinion of the investigator or per the PRALUENT local label, would make the participant unsuitable for enrollment or could interfere with the participant participating in or completing the open-label extension (OLE) study 4. Known hypersensitivity to monoclonal antibody or any component of the drug product 5. Pregnant or breastfeeding women Note: Other inclusion/ exclusion criteria apply

Sex/Gender

Sexes Eligible for Study:

All

Ages

40 Years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Listed Location Countries ^ICMJE

Removed Location Countries

Administrative Information

Has Data Monitoring Committee

U.S. FDA-regulated Product

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

Plan to Share IPD:

Responsible Party

，

Study Sponsor ^ICMJE

Regeneron Pharmaceuticals

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director: Clinical Trial Management Regeneron Pharmaceuticals

PRS Account

Verification Date

October 2018

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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