A Phase 2 interventional study of AKCEA-ANGPTL3-LRX in Homozygous Familial Hypercholesterolemia, sponsored by Akcea Therapeutics. Withdrawn at 1 site in Canada. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-12-03.
Sponsored by Akcea Therapeutics (part of Ionis Pharmaceuticals, Inc.) · Phase 2, Interventional, and Treatment
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 Hypercholesterolemia (HoFH).
68 studies on the registry are indexed under Homozygous Familial Hypercholesterolemia; 13 are open to participants now.
Browse Homozygous Familial Hypercholesterolemia studies →Akcea Therapeutics is the lead sponsor of 15 studies on the registry; 1 is open to participants now.
Of its 9 completed or terminated interventional studies of FDA-regulated products, 8 (89%) have results posted.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HbA1c
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Drug: AKCEA-ANGPTL3-LRX
Single open-label cohort
Also known as: ISIS 703802
Reduction of low density lipoprotein cholesterol (LDL-C).
Percent change in LDL-C from Baseline to week 14.
Time frame: 14 weeks
Effect of ISIS 703802 on plasma angiopoietin like 3 (ANGPTL3).
Absolute and percentage change in ANGPTL3 protein from Baseline to Week 14 will be summarized.
Time frame: 7 and 14 Weeks
Effect of ISIS 703802 on lipid parameters.
Absolute and percentage change from Baseline to Week 14 will be summarized.
Time frame: 7 and 14 Weeks
Evaluate plasma trough levels of ISIS 703802.
Plasma trough levels of ISIS 703802 during treatment period and those during post-treatment follow up period will be descriptively summarized.
Time frame: 14 Weeks
The safety of ISIS 703802 by the incidence of treatment-emergent adverse events
The safety of ISIS 703802 will be assessed by determining adverse effects.
Time frame: 14 Weeks
Started Apr 2018 (actual). Primary completion is estimated for Sep 2018, 5 months after the start.
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This study is withdrawn, as verified in Nov 2018. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Vupanorsen
Homozygous Familial Hypercholesterolemia →