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

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 - TAUSSIG - 20110271

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON40135

Enrollment

Registered

2013-07-04

Start date

2014-01-29

Completion date

Unknown

Last updated

2024-04-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

hypercholesterolemia

Interventions

AMG 145 every four weeks or every 2 weeks for patients with apheresis or patient with pending observed LDL-C levels and insufficient suppression of PCSK9 (> 100 ng/mL).

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Males and females, >= 12 to

Exclusion criteria

Exclusion criteria: use of Mipomersen or Lomitapide within 5 months of screening; New York Heart Failure Association (NYHA) class III or IV or last known left ventricular ejection fraction 180 mmHg or diastolic BP (DBP) > 110 mmHg; requiring statin up-titration within 4 weeks of screening; estimated glomerular filtration rate (eGFR) 3x ULN, creatine kinase (CK) > 5x ULN without a known cause; known major active infection, use of CETP inhibitor in the last 12 months prior to LDL-C screening

Design outcomes

Primary

Measure	Time frame
Subject incidence of treatment emergent adverse events	—

Secondary

Measure	Time frame
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 ApoB from baseline at each scheduled vist • Percent change in Lp(a) 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	—

Measure

Time frame

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 ApoB from baseline at each scheduled vist • Percent change in Lp(a) 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

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)