Canadian Phase Onward | Toronto, Canada
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About
The purpose of this study is to evaluate the safety and tolerability of olezarsen in participants with SHTG.
Full description
This is a multi-center, open-label study of up to 800 participants with SHTG who would be rolled over from studies ISIS 678354-CS5 (NCT05079919) or ISIS 678354-CS6 (NCT05552326). Day 1 of this study may be same as the Week 53 visit of either ISIS 678354-CS5 or ISIS 678354-CS6, as applicable. Participants will receive olezarsen during the 53-week treatment period. The study will include a 31-day qualification Period, a 53-week treatment period, and a 13-week post-treatment period.
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Inclusion and exclusion criteria
Key Inclusion Criteria:
Key Exclusion Criteria:
NOTE: Other Inclusion/Exclusion criteria may apply.
Primary purpose
Allocation
Interventional model
Masking
800 participants in 1 patient group
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Central trial contact
Ionis Pharmaceuticals, Inc.
Data sourced from clinicaltrials.gov
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