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Phase 2 Study of AKCEA-ANGPTL3-LRX (ISIS 703802) in Patients With Familial Chylomicronemia Syndrome (FCS)

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ClinicalTrials.gov Identifier: NCT03360747
Recruitment Status : Active, not recruiting
First Posted : December 4, 2017
Last Update Posted : August 1, 2018
Sponsor:
Collaborator:
Ionis Pharmaceuticals, Inc.
Information provided by (Responsible Party):
Akcea Therapeutics

November 18, 2017
December 4, 2017
August 1, 2018
December 21, 2017
July 30, 2018   (Final data collection date for primary outcome measure)
Change from baseline in fasting TG [ Time Frame: 3 months ]
Percent change and change from baseline to Month 3 in fasting TG will be summarized.
Same as current
Complete list of historical versions of study NCT03360747 on ClinicalTrials.gov Archive Site
  • Change from baseline in fasting ANGPTL3 [ Time Frame: 3 months ]
    Percent change and change from baseline to Month 3 will be summarized in fasting ANGPTL3
  • Change from baseline in fasting lipid measurements [ Time Frame: 3 months ]
    Percent change and change from baseline to Month 3 will be summarized
Same as current
Not Provided
Not Provided
 
Phase 2 Study of AKCEA-ANGPTL3-LRX (ISIS 703802) in Patients With Familial Chylomicronemia Syndrome (FCS)
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)
This is a single center, open-label study to evaluate the efficacy of AKCEA-ANGPTL3-LRX for reduction of triglyceride (TG) levels in patients with Familial Chylomicronemia Syndrome (FCS) .
Not Provided
Interventional
Phase 2
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Familial Chylomicronemia Syndrome
  • Lipoprotein Lipase Deficiency
  • Hyperlipoproteinemia Type 1
Drug: AKCEA-ANGPTL3-LRX
Single open-label cohort
Other Name: ISIS 703802
Experimental: AKCEA-ANGPTL3-LRX Dose 1
Intervention: Drug: AKCEA-ANGPTL3-LRX
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
3
Same as current
September 30, 2018
July 30, 2018   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Genetically confirmed Chylomicronemia Syndrome
  • Fasting triglycerides ≥ 750 mg/dL (8.4 mmol/L) at Screening

Exclusion Criteria:

  • 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
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
Canada
 
 
NCT03360747
ISIS 703802-CS3
Not Provided
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Not Provided
Akcea Therapeutics
Akcea Therapeutics
Ionis Pharmaceuticals, Inc.
Not Provided
Akcea Therapeutics
July 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP