stage IIIa cardiac AL amyloidosis
Conditions
Brief summary
A hierarchical combination of time to all-cause Mortality (ACM) and the frequency of cardiovascular hospitalizations (CVH). Incidence of treatment emergent adverse events (TEAEs) and serious adverse events (SAEs). Changes from baseline in vital signs, weight, clinical laboratory tests, and 12lead electrocardiograms (ECGs).
Detailed description
Time to ACM in Primary Evaluation Treatment Period (PETP), Frequency of CVH in PETP, Changes from baseline to Week 50 in the KCCQ-OS., Change from baseline to Week 50 in NTproBNP, Changes from baseline to Week 50 in GLS%., Changes from baseline to Week 50 in the 6MWT, Change from baseline to Week 50 in the SF-36v2 PCS
Interventions
DRUGSODIUM CHLORIDE
DRUGCAEL-101
Sponsors
Alexion Pharmaceuticals Inc.
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| A hierarchical combination of time to all-cause Mortality (ACM) and the frequency of cardiovascular hospitalizations (CVH). Incidence of treatment emergent adverse events (TEAEs) and serious adverse events (SAEs). Changes from baseline in vital signs, weight, clinical laboratory tests, and 12lead electrocardiograms (ECGs). | — |
Secondary
| Measure | Time frame |
|---|---|
| Time to ACM in Primary Evaluation Treatment Period (PETP), Frequency of CVH in PETP, Changes from baseline to Week 50 in the KCCQ-OS., Change from baseline to Week 50 in NTproBNP, Changes from baseline to Week 50 in GLS%., Changes from baseline to Week 50 in the 6MWT, Change from baseline to Week 50 in the SF-36v2 PCS | — |
Countries
Austria, Czechia, France, Germany, Greece, Italy, Poland, Spain
Outcome results
None listed