An Open-Label Extension Study to Assess the Long-Term Safety and Efficacy of ISIS 301012 in Patients with Familial Hypercholesterolemia or Severe Hypercholesterolemia

Genzyme Europe B.V.0 个研究点目标入组 142 人开始时间: 2008年5月2日最近更新: 2019年11月25日

适应症

试验速览

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•1. Satisfactory completion of dosing and Week 28 assessments in their initial study (ISIS 301012-CS5, ISIS 301012-CS7 or MIPO3500108) with an acceptable safety profile, per Investigator judgment
•2. Able and willing to participate in a 130-week study
•3. Satisfy one of the following: (a) Females: Non-pregnant and non-lactating; surgically sterile, post-menopausal, abstinent, or subject or partner compliant with an acceptable contraceptive regimen for 4 weeks prior to, during, and 24 weeks after the last dose of ISIS 301012 OR (b) Males: Surgically sterile, abstinent or subject or partner is utilizing an acceptable contraceptive method during and 24 weeks after the last dose of ISIS 301012
•4. Given informed consent, or, in the case of minors, the subject’s parents/legal guardians must be capable and willing of giving informed consent, and, if appropriate for the subject’s age, the subject must be capable of giving consent/ assent for study participation.
•Are the trial subjects under 18? yes
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range

•1. Have any new condition or worsening of existing condition which in the opinion of the Investigator would make the subject unsuitable for enrollment, or could interfere with the subject participating in or completing the study.
•2. Unwilling to limit alcohol consumption for the entire duration of the study, including follow-up: male subjects to a maximum of 2 drinks (20 g) per day, and 8 drinks (80 g) per week; female subjects to a maximum of 1 drink (10 g) per day, and 4 drinks (40 g) per week.

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