A Extension Study to Evaluate Revusiran (ALN-TTRSC) in Patients With Transthyretin (TTR) Cardiac Amyloidosis
| Status: | Completed |
|---|---|
| Conditions: | Hematology |
| Therapuetic Areas: | Hematology |
| Healthy: | No |
| Age Range: | 18 - 90 |
| Updated: | 7/20/2018 |
| Start Date: | October 2014 |
| End Date: | February 22, 2017 |
A Phase 2, Open-label Extension Study to Evaluate the Long-Term Safety, Clinical Activity, and Pharmacokinetics of ALN-TTRSC in Patients With Transthyretin (TTR) Cardiac Amyloidosis Who Have Previously Received ALN-TTRSC
The purpose of this study was to evaluate the safety and clinical activity of long-term
dosing with revusiran (ALN-TTRSC). Dosing has been discontinued; patients are being
followed-up for safety.
dosing with revusiran (ALN-TTRSC). Dosing has been discontinued; patients are being
followed-up for safety.
Inclusion Criteria:
- Subjects who previously received and tolerated revusiran (ALN-TTRSC) in the
ALN-TTRSC-002 study
- Adequate liver function
- Not Pregnant or nursing
Exclusion Criteria:
- Inadequate renal function
- Uncontrolled hypertension, ischemic heart disease or clinically significant cardiac
arrhythmia
- Untreated hypo- or hyperthyroidism
- Prior major organ transplant
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