Study of AKCEA-ANGPTL3-LRX (ISIS 703802) in Patients With Homozygous Familial Hypercholesterolemia (HoFH)

Launched by AKCEA THERAPEUTICS · Mar 5, 2018

Keywords

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Gender

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Eligibility criteria

• Inclusion Criteria:
• • Body mass index (BMI) ≤ 35 kg/m2,
• • Genetic confirmation of two mutant alleles at the LDLR, APOB, PCSK9, or LDLRAP1 gene locus OR an untreated LDL-C \> 500 mg/dL (13 mmol/L) or treated LDL-C ≥ 300 mg/dL (2.59 mmol/L) together with either cutaneous or tendon xanthoma before age 10 years OR familial medical history of genetically confirmed heterozygous FH in both parents OR untreated elevated LDL-C and TC \> 250 mg/dL consistent with the disease,
• • Patients must be on stable LDL-C lowering agents or on regular apheresis
• Exclusion Criteria:
• • Myocardial infarction, percutaneous transluminal coronary intervention, or coronary artery bypass graft surgery within 12 weeks prior to Screening, or cerebrovascular accident within 24 weeks prior to Screening.
• • Diabetes mellitus if newly diagnosed or if HbA1c ≥ 9.0%