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A Phase 3 Global, Double-Blind, Randomized, Placebo‑Controlled Study to Evaluate the Efficacy and Safety of ION-682884 in Patients with Transthyretin‑Mediated Amyloid Cardiomyopathy (ATTR CM)
Description
Randomized, double-blind, placebo-controlled study of ION‑682884 vs. placebo administered by SC injection once every 4 weeks for 120 weeks in patients with ATTR-CM receiving available background SoC. Patients will be stratified at Randomization based on NYHA Classification (I and II vs. III), ATTR mutation status (mutated vs. wild-type), 6MWT (≤ 350 meters vs. > 350 meters), and current treatment with tafamidis (Yes vs. No). Study Drug (ION‑682884 or placebo) will be administered for 120 weeks (Treatment Period) followed by an additional 20 weeks of Post-Treatment Evaluation Period.
MoreDetails
Age
Adult
Eligibility
Patients with Amyloid Cardiomyopathy (ATTR-CM)
Phase
III - Research Studies that gather more information about a drug's safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. These studies typically involve more participants.
Type of Study
Treatment
Location
University of Colorado Hospital
Principal Investigator
Amrut Ambardekar
Study ID
Protocol Number: 19-2854
ClinicalTrials.gov: NCT04136171
Categories
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