Study of AKCEA-ANGPTL3-LRX (ISIS 703802) in Patients With Homozygous Familial Hypercholesterolemia (HoFH)
NCT ID: NCT03455777
Last Updated: 2018-12-03
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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WITHDRAWN
PHASE2
INTERVENTIONAL
2018-04-12
2018-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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AKCEA-ANGPTL3-LRX Dose 1
AKCEA-ANGPTL3-LRX
Single open-label cohort
Interventions
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AKCEA-ANGPTL3-LRX
Single open-label cohort
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Genetic confirmation of two mutant alleles at the LDLR, APOB, PCSK9, or LDLRAP1 gene locus OR an untreated LDL-C \> 500 mg/dL (13 mmol/L) or treated LDL-C ≥ 300 mg/dL (2.59 mmol/L) together with either cutaneous or tendon xanthoma before age 10 years OR familial medical history of genetically confirmed heterozygous FH in both parents OR untreated elevated LDL-C and TC \> 250 mg/dL consistent with the disease,
* Patients must be on stable LDL-C lowering agents or on regular apheresis
Exclusion Criteria
* Diabetes mellitus if newly diagnosed or if HbA1c ≥ 9.0%
18 Years
ALL
No
Sponsors
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Ionis Pharmaceuticals, Inc.
INDUSTRY
Akcea Therapeutics
INDUSTRY
Responsible Party
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Locations
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Clinical Site
Québec, Quebec, Canada
Countries
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Other Identifiers
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ISIS 703802-CS4
Identifier Type: -
Identifier Source: org_study_id
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