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The purpose of this study is to determine the pharmacokinetics, pharmacodynamics and exploratory clinical activity of ALN-TTRSC (revusiran) in Patients with Transthyretin (TTR) Cardiac Amyloidosis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ALN-TTRSC (revusiran) | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ALN-TTRSC (revusiran) for subcutaneous administration | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| The proportion of subjects experiencing adverse events (AEs), serious adverse events (SAEs) and study drug discontinuation. | Up to 63 days |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics (PK) of ALN-TTRSC (revusiran) (Cmax, tmax, t1/2, AUC, CL, Vss, Vz) | Up to 90 days | |
| Effect of ALN-TTRSC (revusiran) on transthyretin (TTR) (Determination of % Lowering of TTR to pretreatment/Baseline Levels) | Up to 90 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jared Gollob, MD | Alnylam Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinical Trial Site | Boston | Massachusetts | 02155 | United States | ||
| Clinical Trial Site |
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| New York |
| New York |
| 10034 |
| United States |
| Clinical Trial Site | Cleveland | Ohio | 44195 | United States |
| Clinical Trial Site | London | UK NW3 2PF | United Kingdom |
| ID | Term |
|---|---|
| C000614277 | revusiran |
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