Familial Hypercholesterolemia MedDRA version: 20.0 Level: LLT Classification code 10057100 Term: Homozygous familial hypercholesterolaemia System Organ Class: 100000012386
Conditions
Sponsors
Amgen Inc
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 4.1.1 Participated in a qualifying AMG 145 parent protocol and have a diagnosis of familial hypercholesterolemia. Subjects must not have experienced an IP treatment related serious adverse event that led to IP discontinuation during their participation in the qualifying AMG 145 parent study, or Subjects that have not participated in a qualifying AMG 145 parent protocol must also meet all of the following inclusion criteria: 4.1.2 Are male or female = 12 to = 80 years of age 4.1.3 Have a diagnosis of familial hypercholesterolemia 4.1.4 Are on a stable low-fat diet and taking pre-existing lipid-lowering therapies (such as statins, cholesterol-absorption inhibitors, bile-acid sequestrants or nicotinic acid, or combinations thereof) for at least 4 weeks, with fasting central lab LDL cholesterol concentration and meet the following LDL-C values based on risk factor status (NCEP ATPIII risk categories Grundy et al, 2004): • = 100 mg/dL (2.6 mmol/L) for subjects with diagnosed CHD or CHD risk equivalent (includes clinical manifestations of noncoronary forms of atherosclerotic disease [peripheral arterial disease, abdominal aortic aneurysm, and carotid artery disease], diabetes, and 2+ risk factors with 10-year risk for hard CHD >20%). Risk factors include cigarette smoking, hypertension (BP = 140/90 mm Hg or on antihypertensive medication), low HDL cholesterol (=65 years) yes F.1.3.1 Number of subjects for this age range 46
Exclusion criteria
Exclusion criteria: All subjects will be ineligible for the study if they fulfill any of the following criteria: 4.2.1 Female subject who has either (1) not used an acceptable method(s) of birth control for at least 1 month prior to screening or (2) is not willing to use such a method during treatment with AMG 145 (IP) and for an additional 15 weeks after the end of treatment with AMG 145 (IP) unless subject is sterilized or postmenopausal; • Menopause is defined as 12 months of spontaneous and continuous amenorrhea in a female = 55 years old or 12 months of spontaneous and continuous amenorrhea with a follicle-stimulating hormone level > 40 IU/L (or according to the definition of "postmenopausal range" for the laboratory involved) in a female 180 mmHg or diastolic BP (DBP) > 110 mmHg, confirmed with repeat measurement 4.2.13 Subject requires uptitration of their current statin dose within 4 weeks of screening (these subjects can be uptitrated and rescreened one month later) 4.2.14 Moderate to severe renal dysfunction, defined as an estimated glomerular filtration rate (eGFR) < 30 ml/min/1.73m2 at screening 4.2.15 Active liver disease or hepatic dysfunction, defi
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To characterize the safety and tolerability of long-term administration of AMG 145 among patients with severe familial hypercholesterolemia;Secondary Objective: To characterize the efficacy of long-term administration of AMG 145 as assessed by low density lipoprotein cholesterol (LDL-C) and non-high-density lipoprotein cholesterol (non-HDL-C), Lp(a), apolipoprotein B (ApoB), total cholesterol/HDL-C ratio, ApoB/Apolipoprotein A-1 (ApoA1) ratio, and response of LDL-C reduction (15% or greater) in subjects with severe familial hypercholesterolemia;Primary end point(s): Subject incidence of treatment emergent adverse events.;Timepoint(s) of evaluation of this end point: From baseline to week 24 Q4W, at interval visits (week 16 and 20) and quaterly after week 24 until EoS | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • Percent change in LDL-C from baseline at each scheduled visit • Percent change in non-HDL-C from baseline at each scheduled visit • Percent change in Lp(a) from baseline at each scheduled visit • Percent change in ApoB from baseline at each scheduled visit • Percent change in total cholesterol/HDL-C ratio from baseline at each scheduled visit • Percent change in ApoB/ApoA1 ratio from baseline at each scheduled visit • Response of LDL-C reduction of 15% or greater from baseline at each scheduled visit ;Timepoint(s) of evaluation of this end point: • Percent change in LDL-C from baseline at each scheduled visit • Percent change in non-HDL-C from baseline at each scheduled visit • Percent change in Lp(a) from baseline at each scheduled visit • Percent change in ApoB from baseline at each scheduled visit • Percent change in total cholesterol/HDL-C ratio from baseline at each scheduled visit • Percent change in ApoB/ApoA1 ratio from baseline at each scheduled visit | — |
Countries
Australia, Austria, Belgium, Brazil, Canada, Czech Republic, France, Greece, Hong Kong, Israel, Italy, Japan, Lebanon, Malaysia, Netherlands, New Zealand, South Africa, Spain, Turkey, United Kingdom, United States
Contacts
Public ContactIHQ Medical Info - Clinical Trials
Amgen (EUROPE) GmbH
Outcome results
None listed