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Evaluate the Long-Term Safety and Efficacy of Evinacumab in Patients With Homozygous Familial Hypercholesterolemia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03409744
Recruitment Status : Active, not recruiting
First Posted : January 24, 2018
Last Update Posted : November 12, 2020
Sponsor:
Information provided by (Responsible Party):
Regeneron Pharmaceuticals

Tracking Information
First Submitted Date  ICMJE January 8, 2018
First Posted Date  ICMJE January 24, 2018
Last Update Posted Date November 12, 2020
Actual Study Start Date  ICMJE March 13, 2018
Estimated Primary Completion Date April 18, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 17, 2018)
Incidence and severity of treatment-emergent adverse events (TEAEs) [ Time Frame: Up to 192 weeks ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 17, 2018)
  • Percent change in Low-Density Lipoprotein Cholesterol (LDL-C) over time [ Time Frame: Up to 192 weeks ]
  • Absolute change in LDL-C over time [ Time Frame: Up to 192 weeks ]
  • Percent change in Apolipoprotein B (Apo B) over time [ Time Frame: Up to 192 weeks ]
  • Absolute change in Apo B over time [ Time Frame: Up to 192 weeks ]
  • Percent change in non-High-Density Lipoprotein Cholesterol (HDL-C) over time [ Time Frame: Up to 192 weeks ]
  • Absolute change in non-HDL-C over time [ Time Frame: Up to 192 weeks ]
  • Percent change in Total Cholesterol (TC) over time [ Time Frame: Up to 192 weeks ]
  • Absolute change in TC over time [ Time Frame: Up to 192 weeks ]
  • Percent change in Triglycerides (TGs) over time [ Time Frame: Up to 192 weeks ]
  • Absolute change in TGs over time [ Time Frame: Up to 192 weeks ]
  • Presence of anti-evinacumab antibodies [ Time Frame: Up to 192 weeks ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Evaluate the Long-Term Safety and Efficacy of Evinacumab in Patients With Homozygous Familial Hypercholesterolemia
Official Title  ICMJE An Open-Label Study to Evaluate the Long-Term Safety and Efficacy of Evinacumab in Patients With Homozygous Familial Hypercholesterolemia
Brief Summary

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 evaluabe the effect of evinacumab on lipd parameters in adolescent patients with HoFH
  • To evaluate the potential development of anti-evinacumab antibodies
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Homozygous Familial Hypercholesterolemia
Intervention  ICMJE Drug: evinacumab
Intravenous (IV) administration
Other Name: REGN1500
Study Arms  ICMJE Experimental: evinacumab
Intervention: Drug: evinacumab
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: November 10, 2020)
116
Original Estimated Enrollment  ICMJE
 (submitted: January 17, 2018)
66
Estimated Study Completion Date  ICMJE April 18, 2022
Estimated Primary Completion Date April 18, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Key Inclusion Criteria:

  1. Completion of the parent study in which they participated
  2. Able to understand and complete study-related questionnaires

Key Exclusion Criteria:

  1. Significant protocol deviation in the parent study based on the investigator's judgment, such as non-compliance by the patient
  2. Concomitant medications that have not been stable prior to the baseline visit
  3. Adverse event leading to permanent discontinuation from parent study
  4. Any new condition or worsening of an existing condition, which in the opinion of the investigator would make the patient unsuitable for enrollment, or could interfere with the patient participating in or completing the study
  5. Member of the clinical site study team and/or his/her immediate family
  6. Pregnant or breastfeeding women
  7. Women of childbearing potential who are unwilling to practice highly effective contraception prior to the initial dose/start of the first treatment, during the study, and for at least 24 weeks after the last dose of study drug
  8. Men who are sexually active with women of childbearing potential and are unwilling to use the following forms of medically acceptable birth control during the study drug treatment period and for 24 weeks after the last injection of study drug: vasectomy with medical assessment of surgical success OR consistent use of a condom.

Note: Other protocol defined Inclusion/Exclusion criteria apply

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 12 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Australia,   Austria,   Canada,   Czechia,   France,   Greece,   Italy,   Japan,   Netherlands,   South Africa,   Ukraine,   United States
Removed Location Countries Norway
 
Administrative Information
NCT Number  ICMJE NCT03409744
Other Study ID Numbers  ICMJE R1500-CL-1719
2017-003170-13 ( EudraCT Number )
Has Data Monitoring Committee Yes
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  ICMJE Not Provided
Responsible Party Regeneron Pharmaceuticals
Study Sponsor  ICMJE Regeneron Pharmaceuticals
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Clinical Trial Management Regeneron Pharmaceuticals
PRS Account Regeneron Pharmaceuticals
Verification Date November 2020

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