Adults with Transthyretin Amyloid Cardiomyopathy (ATTR-CM).
Conditions
Brief summary
Total occurrence of ACM and CV clinical events during the Blinded Treatment Period
Detailed description
Change from baseline in KCCQ-OS to 24 months, Time to CV related mortality, Change from baseline in 6MWT to 24 months, Rate of CV clinical events, Time to ACM, Incidence of TEAEs and treatment-emergent SAEs. Changes from baseline in physical examination, vital signs, clinical laboratory tests, and 12-lead ECGs, ADA incidence and NAb incidence, response categories and titer, Serum ALXN2220 concentration
Interventions
DRUGALXN2220 Placebo Product
Sponsors
Alexion Pharmaceuticals Inc.
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Total occurrence of ACM and CV clinical events during the Blinded Treatment Period | — |
Secondary
| Measure | Time frame |
|---|---|
| Change from baseline in KCCQ-OS to 24 months, Time to CV related mortality, Change from baseline in 6MWT to 24 months, Rate of CV clinical events, Time to ACM, Incidence of TEAEs and treatment-emergent SAEs. Changes from baseline in physical examination, vital signs, clinical laboratory tests, and 12-lead ECGs, ADA incidence and NAb incidence, response categories and titer, Serum ALXN2220 concentration | — |
Countries
Austria, Belgium, Czechia, Denmark, France, Germany, Greece, Ireland, Italy, Netherlands, Norway, Poland, Spain, Sweden
Outcome results
None listed