Status:
COMPLETED
Study of REGN1500 in Participants With Homozygous Familial Hypercholesterolemia (HoFH)
Lead Sponsor:
Regeneron Pharmaceuticals
Conditions:
Homozygous Familial Hypercholesterolemia
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
This is an open-label, single-arm study to assess the reduction of low-density lipoprotein cholesterol (LDL-C) by REGN1500 in patients with homozygous familial hypercholesterolemia (HoFH).
Eligibility Criteria
Inclusion
- Men and women ≥18 years of age at the time of the screening visit
- Diagnosis of homozygous familial hypercholesterolemia (HoFH)
- Willing to consistently maintain usual diet for the duration of the study
Exclusion
- Background medical lipid modifying therapy that has not been stable for at least 4 weeks (6 weeks for fibrates) prior to the screening visit
- Having undergone lipid apheresis within 4 weeks prior to the screening visit
- Use of another investigational drug or therapy within 30 days or at least 5 half-lives (whichever is longer) prior to the screening visit
- Previous participation in any clinical trial of REGN1500
- Note: The information listed above is not intended to contain all considerations relevant to a patient's potential participation in this clinical trial therefore not all inclusion/ exclusion criteria are listed.
Key Trial Info
Start Date :
February 4 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 23 2018
Estimated Enrollment :
9 Patients enrolled
Trial Details
Trial ID
NCT02265952
Start Date
February 4 2015
End Date
July 23 2018
Last Update
December 9 2019
Active Locations (5)
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1
Los Angeles, California, United States
2
Philadelphia, Pennsylvania, United States
3
Dallas, Texas, United States
4
Chicoutimi, Quebec, Canada