Study of REGN1500 in Patients With Homozygous Familial Hypercholesterolemia (HoFH)
Status: | Completed |
---|---|
Conditions: | High Cholesterol |
Therapuetic Areas: | Cardiology / Vascular Diseases |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 8/3/2018 |
Start Date: | February 4, 2015 |
End Date: | July 23, 2018 |
An Open-Label, Single-Arm, Proof-of-Concept Study to Evaluate the Safety and Efficacy of Single and Multiple Doses of REGN1500 in Patients With Homozygous Familial Hypercholesterolemia
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).
cholesterol (LDL-C) by REGN1500 in patients with homozygous familial hypercholesterolemia
(HoFH).
Inclusion Criteria:
1. Men and women ≥18 years of age at the time of the screening visit
2. Diagnosis of homozygous familial hypercholesterolemia (HoFH)
3. Willing to consistently maintain usual diet for the duration of the study
Exclusion Criteria:
1. Background medical lipid modifying therapy that has not been stable for at least 4
weeks (6 weeks for fibrates) prior to the screening visit
2. Having undergone lipid apheresis within 4 weeks prior to the screening visit
3. Use of another investigational drug or therapy within 30 days or at least 5 half-lives
(whichever is longer) prior to the screening visit
4. 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.
We found this trial at
5
sites
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