Status:
COMPLETED
Phase 2 Study of AKCEA-ANGPTL3-LRx (ISIS 703802) in Participants With Familial Chylomicronemia Syndrome (FCS)
Lead Sponsor:
Akcea Therapeutics
Collaborating Sponsors:
Ionis Pharmaceuticals, Inc.
Conditions:
Familial Chylomicronemia Syndrome
Lipoprotein Lipase Deficiency
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 triglyceride (TG) levels in participants with FCS.
Eligibility Criteria
Inclusion
- Key
- Genetically confirmed chylomicronemia syndrome.
- Fasting triglycerides greater than or equal to (\>=) 750 milligrams per deciliter (mg/dL) \[8.4 millimoles per liter (mmol/L)\] at Screening.
- Key
Exclusion
- Diabetes mellitus if newly diagnosed or if glycated hemoglobin (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.
Key Trial Info
Start Date :
December 21 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 4 2018
Estimated Enrollment :
3 Patients enrolled
Trial Details
Trial ID
NCT03360747
Start Date
December 21 2017
End Date
September 4 2018
Last Update
January 7 2021
Active Locations (1)
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1
Investigative Site
Montreal, Quebec, Canada, H2W 1R7