Transthyretin Amyloid Cardiomyopathy Clinical Trial
Official title:
A Phase 3, Randomized Study, With Initial 24-week, Double-Blind and Placebo-Controlled Treatment Phase, Followed by An 80-week Open-label Extension Treatment Phase to Evaluate the Effect of Eplontersen on the Transthyretin Reduction and Long-Term Safety in Chinese Participants With Transthyretin Amyloid Cardiomyopathy (EPIC-ATTR)
The purpose of this study is to investigate the effect of eplontersen compared to placebo on the reduction of serum TTR concentration and long-term safety in Chinese participants with hereditary or wild-type transthyretin amyloid cardiomyopathy.
This is a Phase 3, randomized study, with initial 24-week double-blind and placebo-controlled treatment phase, then followed by an open-label extension treatment phase to evaluate the effect of eplontersen on the TTR reduction and long-term safety in Chinese participants with ATTR-CM. Eligible participants will be randomized in a 3:1 ratio to either eplontersen or placebo for a treatment period of 24 weeks. The double-blind treatment phase will be followed by 80-week open label treatment phase (Participants initially assigned to placebo will switch to eplontersen treatment at 24 weeks), to evaluate long term safety and tolerability of eplontersen treatment. This study will be performed in about 30 to 35 study centres in China mainland. ;
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