Phase 2 Study of AKCEA-ANGPTL3-LRX (ISIS 703802) in Patients With Familial Chylomicronemia Syndrome (FCS)
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A Phase 2 Open-Label Study to Assess the Pharmacodynamics, Pharmacokinetics, Safety and Tolerability of AKCEA-ANGPTL3-LRX (ISIS 703802) Administered Subcutaneously to Patients With Familial Chylomicronemia Syndrome (FCS)
Actual Study Start Date :
December 21, 2017
Estimated Primary Completion Date :
July 30, 2018
Estimated Study Completion Date :
September 30, 2018
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Ages Eligible for Study:
18 Years and older (Adult, Senior)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Genetically confirmed Chylomicronemia Syndrome
Fasting triglycerides ≥ 750 mg/dL (8.4 mmol/L) at Screening
Diabetes mellitus if newly diagnosed or if HbA1c ≥ 9.0%
Active pancreatitis within 2 weeks of screening
Acute Coronary Syndrome within 6 months of screening
Major surgery within 3 months of screening
Treatment with Glybera therapy within 2 years of screening
Previous treatment with AKCEA-ANGPTL3-LRX
Have any other conditions in the opinion of the investigator which could interfere with the patient participating in or completing the study