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Long Term Safety Study of PRALUENT

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ClinicalTrials.gov Identifier: NCT03694197
Recruitment Status : Terminated (The primary objective (to evaluate the long-term safety of Praluent) was adequately evaluated in other studies.)
First Posted : October 3, 2018
Results First Posted : June 15, 2021
Last Update Posted : June 15, 2021
Sponsor:
Collaborator:
Sanofi
Information provided by (Responsible Party):
Regeneron Pharmaceuticals

Brief Summary:

The primary objective of the study was to evaluate the long term safety of PRALUENT in participants with heterozygous familial hypercholesterolemia (heFH) or non-familial hypercholesterolemia (FH) participants at high or very high cardiovascular risk who completed the neurocognitive function study R727-CL-1532 (NCT02957682).

The secondary objectives of the study were:

  • 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

Condition or disease Intervention/treatment Phase
Heterozygous Familial Hypercholesterolemia Non-familial Hypercholesterolemia Drug: Praluent Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1389 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : September 28, 2018
Actual Primary Completion Date : April 8, 2020
Actual Study Completion Date : April 8, 2020

Resource links provided by the National Library of Medicine

Drug Information available for: Alirocumab

Arm Intervention/treatment
Experimental: Open label Drug: Praluent
Subcutaneous (SC) administration
Other Names:
  • Alirocumab
  • REGN727
  • SAR236553




Primary Outcome Measures :
  1. Number of Participants With Adverse Events (AE) After First Administration of Study Drug Through the Last Dose of Study Drug Plus 2 Weeks [ Time Frame: After first administration of study drug through the last dose of study drug plus 2 weeks, up to 80 weeks ]
    An AE is any untoward medical occurrence in a participant administered a study drug which may or may not have a causal relationship with the study drug. AEs include serious adverse events (SAEs), AEs leading to treatment discontinuation, and adverse events of special interest (AESI). AESI include local injection site reactions, general allergic events, elevated alanine aminotransferase (ALT) levels greater than or equal to (≥) 3 upper limit normal (ULN) (if baseline is less than (<) ULN)/ALT ≥2 x ULN (if baseline ≥ ULN), neurologic events, neurocognitive events (according to Customized Medical Dictionary for Regulatory Activities [MedDRA] Query [CMQ] by Sponsor grouping and CMQ by FDA grouping), cataract, new onset diabetes (NOD), hepatic disorders, and diabetes mellitus (DM)/diabetic complications.


Secondary Outcome Measures :
  1. Calculated Low-density Lipoprotein Cholesterol (LDL-C) Values From Baseline Over Time [ Time Frame: Up to week 72 ]
    The baseline value was defined as the last available value before the first dose of double-blind study treatment in study R727-CL-1532 (NCT02957682)

  2. Percent Change in LDL-C From Baseline Over Time [ Time Frame: Up to week 72 ]
  3. Total Cholesterol (Total-C) Values From Baseline Over Time [ Time Frame: Up to week 72 ]
    The baseline value was defined as the last available value before the first dose of double-blind study treatment in study R727-CL-1532 (NCT02957682)

  4. Percent Change From Baseline in Total-C Over Time [ Time Frame: Up to week 72 ]
  5. Lipoprotein a (Lp(a)) Values From Baseline Over Time [ Time Frame: Up to week 72 ]
    The baseline value was defined as the last available value before the first dose of double-blind study treatment in study R727-CL-1532 (NCT02957682)

  6. Percent Change From Baseline in Lp(a) Over Time [ Time Frame: Up to week 72 ]
  7. Non-high-density Lipoprotein Cholesterol (Non-HDL-C) Values From Baseline Over Time [ Time Frame: Up to week 72 ]
    The baseline value was defined as the last available value before the first dose of double-blind study treatment in study R727-CL-1532 (NCT02957682)

  8. Percent Change From Baseline in Non-HDL-C Over Time [ Time Frame: Up to week 72 ]
  9. High-density Lipoprotein Cholesterol (HDL-C) Values From Baseline Over Time [ Time Frame: Up to week 72 ]
    The baseline value was defined as the last available value before the first dose of double-blind study treatment in study R727-CL-1532 (NCT02957682)

  10. Percent Change From Baseline in HDL-C Over Time [ Time Frame: Up to week 72 ]
  11. Fasting Triglycerides (TGs) Values From Baseline Over Time [ Time Frame: Up to week 72 ]
    The baseline value was defined as the last available value before the first dose of double-blind study treatment in study R727-CL-1532 (NCT02957682)

  12. Percent Change From Baseline in Fasting TGs Over Time [ Time Frame: Up to week 72 ]
  13. Apolipoprotein B (Apo B) Values From Baseline Over Time [ Time Frame: Up to week 72 ]
    The baseline value was defined as the last available value before the first dose of double-blind study treatment in study R727-CL-1532 (NCT02957682)

  14. Percent Change From Baseline in Apo B Over Time [ Time Frame: Up to week 72 ]
  15. Apolipoprotein-A1 (Apo A1) Values From Baseline Over Time [ Time Frame: Up to week 72 ]
    The baseline value was defined as the last available value before the first dose of double-blind study treatment in study R727-CL-1532 (NCT02957682)

  16. Percent Change From Baseline in Apo A1 Over Time [ Time Frame: Up to week 72 ]
  17. Gonadal Hormone (Follicle Stimulating Hormone [FSH] and Luteinizing Hormone [LH]) Values for Female Participants From Baseline Over Time [ Time Frame: Up to week 72 ]
    The baseline value was defined as the last available value before the first dose of double-blind study treatment in study R727-CL-1532 (NCT02957682)

  18. Change From Baseline in Gonadal Hormones (FSH and LH) for Female Participants Over Time [ Time Frame: Up to week 72 ]
  19. Gonadal (FSH and LH) Hormone Values for Male Participants From Baseline Over Time [ Time Frame: Up to week 72 ]
    The baseline value was defined as the last available value before the first dose of double-blind study treatment in study R727-CL-1532 (NCT02957682)

  20. Change From Baseline in Gonadal Hormones (FSH and LH) for Male Participants Over Time [ Time Frame: Up to week 72 ]
  21. Gonadotropin (Estradiol) Values for Female Participants From Baseline Over Time [ Time Frame: Up to week 72 ]
    The baseline value was defined as the last available value before the first dose of double-blind study treatment in study R727-CL-1532 (NCT02957682)

  22. Change From Baseline in Gonadotropins (Estradiol) for Female Participants Over Time [ Time Frame: Up to week 72 ]
  23. Gonadotropin (Testosterone) Values for Male Participants From Baseline Over Time [ Time Frame: Up to week 72 ]
    The baseline value was defined as the last available value before the first dose of double-blind study treatment in study R727-CL-1532 (NCT02957682)

  24. Change From Baseline in Gonadotropins (Testosterone) for Male Participants Over Time [ Time Frame: Up to week 72 ]
  25. Alanine Aminotransferase Values From Baseline Over Time [ Time Frame: Up to week 72 ]
    The baseline value was defined as the last available value before the first dose of double-blind study treatment in study R727-CL-1532 (NCT02957682)

  26. Change From Baseline in Alanine Aminotransferase Over Time [ Time Frame: Up to week 72 ]
  27. Aspartate Aminotransferase Values From Baseline Over Time [ Time Frame: Up to week 72 ]
    The baseline value was defined as the last available value before the first dose of double-blind study treatment in study R727-CL-1532 (NCT02957682)

  28. Change From Baseline in Aspartate Aminotransferase Over Time [ Time Frame: Up to week 72 ]
  29. Alkaline Phosphatase Values From Baseline Over Time [ Time Frame: Up to week 72 ]
    The baseline value was defined as the last available value before the first dose of double-blind study treatment in study R727-CL-1532 (NCT02957682)

  30. Change From Baseline in Alkaline Phosphatase Over Time [ Time Frame: Up to week 72 ]
  31. Total Bilirubin Values From Baseline Over Time [ Time Frame: Up to week 72 ]
    The baseline value was defined as the last available value before the first dose of double-blind study treatment in study R727-CL-1532 (NCT02957682)

  32. Change From Baseline in Total Bilirubin Over Time [ Time Frame: Up to week 72 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03694197


Locations
Show Show 124 study locations
Sponsors and Collaborators
Regeneron Pharmaceuticals
Sanofi
Investigators
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Study Director: Clinical Trial Management Regeneron Pharmaceuticals
  Study Documents (Full-Text)

Documents provided by Regeneron Pharmaceuticals:
Study Protocol  [PDF] September 17, 2018
Statistical Analysis Plan  [PDF] July 17, 2020

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Responsible Party: Regeneron Pharmaceuticals
ClinicalTrials.gov Identifier: NCT03694197    
Other Study ID Numbers: R727-CL-1609
2018-002810-11 ( EudraCT Number )
First Posted: October 3, 2018    Key Record Dates
Results First Posted: June 15, 2021
Last Update Posted: June 15, 2021
Last Verified: May 2021

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Hyperlipoproteinemia Type II
Hypercholesterolemia
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Lipid Metabolism, Inborn Errors
Metabolism, Inborn Errors
Genetic Diseases, Inborn
Hyperlipoproteinemias