Dose-escalating Safety Study of ISIS 301012 in Homozygous Familial Hypercholesterolemia Subjects on Lipid Lowering Therapy

Completed · Phase 2

Conditions studied: Hypercholesterolemia, Familial

In brief

The aim of this study is to assess the safety and efficacy of varying doses of ISIS 301012 as add-on therapy in subjects with Homozygous Familial Hypercholesterolemia

Key facts

Study ID

NCT00280995

Run by

Kastle Therapeutics, LLC

People needed

12

Starts

2006-01-01

Expected to finish

2007-08-01

Last updated by the study team

2016-08-03

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Weight ≥ 40 kg for Cohorts A, B, \& C; Weight ≥ 50 kg for Cohort D
• Diagnosis of Homozygous Familial Hypercholesterolemia.
• Female must be non-pregnant and non-lactating.
• On stable lipid lowering therapy for at least 4 weeks.
• Lipid values that meet the pre-specified criteria.

You may not qualify if…

• Subject had heart problems in the prior 6 months.
• Subject has elevated ALT, AST, or CPK.
• History of renal disease, liver disease, or malignancy.
• Use of oral anticoagulants, unless the dose has been stable for 4 weeks
• Have any other conditions, 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.

Where it is running

• Study site — Chicago, Illinois, United States
• Study site — New York, New York, United States
• Study site — Winston-Salem, North Carolina, United States
• Study site — Cincinnati, Ohio, United States
• Study site — Houston, Texas, United States
• Study site — Amsterdam, Netherlands

Full record on ClinicalTrials.gov

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