AMG 145 in patients with Severe Familial Hypercholesterolemia
Research type
Research Study
Full title
A Multicenter, Open-label Study to Assess the Long-term Safety, Tolerability, and Efficacy of AMG 145 on LDL-C in Subjects With Severe Familial Hypercholesterolemia
IRAS ID
125643
Contact name
Handrean Soran
Contact email
Sponsor organisation
Amgen Inc
Eudract number
2011-005400-15
Research summary
The purpose of this study is to find out more about an investigational product called AMG 145 in people with severe hypercholesterolemia. AMG 145 is a human monoclonal antibody that attaches to a natural protein called PCSK9 that is produced by the liver. By attaching to PCSK9, AMG 145 is expected to lower bad cholesterol (LDL-cholesterol) in the blood. This study will examine if long-term treatment with AMG 145 is effective at lowering LDL-cholesterol levels.
The study will focus on patients with severe familial hypercholesterolemia and is an open label study with all patients receiving study drug, AMG145. AMG145 will be given either 2 weekly or 4 weekly at a 6ml dose by subcutaneous injections. Patients will remain on the study for 5 years.
Patients are included in the study if they have completed a parent protocol, however in the UK this parent protocol is not being conducted, therefore patients will enter the study if they are either receiving apheresis for their hypercholesterolemia or meet the high levels of cholesterol, or genotyping (genetic diagnosis of homozygous familial hypercholesterolemia) to enter this study.
REC name
North West - Greater Manchester Central Research Ethics Committee
REC reference
13/NW/0199
Date of REC Opinion
22 May 2013
REC opinion
Further Information Favourable Opinion