Open Label Extension of ISIS 301012 (Mipomersen) to Treat Familial Hypercholesterolemia
Lipid Metabolism, Inborn Errors, Hypercholesterolemia, Autosomal Dominant, Hyperlipidemias
About this trial
This is an interventional treatment trial for Lipid Metabolism, Inborn Errors focused on measuring Familial Hypercholesterolemia, Heterozygous Familial Hypercholesterolemia, Homozygous Familial Hypercholesterolemia, ISIS 301012, mipomersen, Open Label Extension
Eligibility Criteria
Inclusion Criteria:
- Satisfactory completion of dosing and Week 7 or Week 15 assessments (depending on the treatment and dose received) in their initial study (Protocol 301012-CS8 (NCT00280995) or 301012-CS9 (NCT00281008)).
Exclusion Criteria:
- Have a new condition or worsening of existing condition which in the opinion of the Investigator would make the patient unsuitable for enrollment, or could interfere with patient's participation in or completion of the study.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Experimental
Experimental
Mipomersen 200 mg per week
Mipomersen 200 mg every other week
Participants received 200 mg mipomersen once a week by subcutaneous injection, for up to 3 years.
Participants received 200 mg mipomersen every other week by subcutaneous injection, for up to 3 years. Participants could receive mipomersen 200 mg once a week at the Investigator's discretion after the first 52 weeks of the treatment period.