Status:
COMPLETED
Dose-escalating Safety Study of ISIS 301012 in Homozygous Familial Hypercholesterolemia Subjects on Lipid Lowering Therapy
Lead Sponsor:
Kastle Therapeutics, LLC
Collaborating Sponsors:
Ionis Pharmaceuticals, Inc.
Conditions:
Hypercholesterolemia, Familial
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
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
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
January 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2007
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT00280995
Start Date
January 1 2006
End Date
August 1 2007
Last Update
August 3 2016
Active Locations (6)
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1
Chicago, Illinois, United States, 60610
2
New York, New York, United States, 10021
3
Winston-Salem, North Carolina, United States, 27103
4
Cincinnati, Ohio, United States, 45229