Dose-escalating Safety Study of ISIS 301012 in Homozygous Familial Hypercholesterolemia Subjects on Lipid Lowering Therapy
NCT ID: NCT00280995
Last Updated: 2016-08-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
12 participants
INTERVENTIONAL
2006-01-31
2007-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Cohort A
Loading doses followed by weekly maintenance doses
ISIS 301012
50 mg subcutaneous injections on days 1, 4, 8, 11, 15, 22, 29, and 36
Cohort B
Loading doses followed by weekly maintenance doses
ISIS 301012
100 mg subcutaneous injections on days 1, 4, 8, 11, 15, 22, 29, and 36
Cohort C
Loading doses followed by weekly maintenance doses
ISIS 301012
200 mg subcutaneous injections on days 1, 4, 8, 11, 15, 22, 29, and 36
Cohort D
Loading doses followed by extended weekly maintenance doses
ISIS 301012
300 mg subcutaneous injections on days 1, 4, 8, 11, 15, 22, 29, 36, 43, 50, 57, 64,71, 78, and 85
Interventions
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ISIS 301012
100 mg subcutaneous injections on days 1, 4, 8, 11, 15, 22, 29, and 36
ISIS 301012
200 mg subcutaneous injections on days 1, 4, 8, 11, 15, 22, 29, and 36
ISIS 301012
300 mg subcutaneous injections on days 1, 4, 8, 11, 15, 22, 29, 36, 43, 50, 57, 64,71, 78, and 85
ISIS 301012
50 mg subcutaneous injections on days 1, 4, 8, 11, 15, 22, 29, and 36
Eligibility Criteria
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Inclusion Criteria
* 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 Criteria
* 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.
18 Years
ALL
No
Sponsors
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Ionis Pharmaceuticals, Inc.
INDUSTRY
Kastle Therapeutics, LLC
INDUSTRY
Responsible Party
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Genzyme Coporation
Principal Investigators
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Medical Monitor
Role: STUDY_DIRECTOR
Genzyme, a Sanofi Company
Locations
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Chicago, Illinois, United States
New York, New York, United States
Winston-Salem, North Carolina, United States
Cincinnati, Ohio, United States
Houston, Texas, United States
Amsterdam, , Netherlands
Countries
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Other Identifiers
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EudraCT No.: 2005-004796-38
Identifier Type: -
Identifier Source: secondary_id
301012CS8
Identifier Type: -
Identifier Source: org_study_id
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