Status:
WITHDRAWN
Study of AKCEA-ANGPTL3-LRX (ISIS 703802) in Patients With Homozygous Familial Hypercholesterolemia (HoFH)
Lead Sponsor:
Akcea Therapeutics
Collaborating Sponsors:
Ionis Pharmaceuticals, Inc.
Conditions:
Homozygous Familial Hypercholesterolemia
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
This is a single center, open-label study to evaluate the efficacy of AKCEA-ANGPTL3- LRX for reduction of low density lipoprotein cholesterol (LDL-C) levels in patients with Homozygous Familial Hyperc...
Eligibility Criteria
Inclusion
- Body mass index (BMI) ≤ 35 kg/m2,
- 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
- Myocardial infarction, percutaneous transluminal coronary intervention, or coronary artery bypass graft surgery within 12 weeks prior to Screening, or cerebrovascular accident within 24 weeks prior to Screening.
- Diabetes mellitus if newly diagnosed or if HbA1c ≥ 9.0%
Key Trial Info
Start Date :
April 12 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2018
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT03455777
Start Date
April 12 2018
End Date
December 31 2018
Last Update
December 3 2018
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Clinical Site
Québec, Quebec, Canada, G1V4W2