A Extension Study to Evaluate Revusiran (ALN-TTRSC) in Patients With Transthyretin (TTR) Cardiac Amyloidosis

Alnylam Pharmaceuticals

Status and phase: Completed; Phase 2

Conditions: TTR-mediated Amyloidosis

Treatments: Drug: Revusiran (ALN-TTRSC)

Study type: Interventional

Funder types: Industry

Identifiers

NCT02292186

ALN-TTRSC-003

Details and patient eligibility

About

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.

Enrollment: 25 patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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25 participants in 1 patient group

Revusiran (ALN-TTRSC)

Experimental group

Treatment:

Drug: Revusiran (ALN-TTRSC)