The Study of ALN-TTR02 (Patisiran) for the Treatment of Transthyretin (TTR)-Mediated Amyloidosis in Patients Who Have Already Been Treated With ALN-TTR02 (Patisiran)

• Status: Completed
• Trial end date: 2016-08-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate the safety and tolerability of long-term dosing with ALN-TTR02 (patisiran) in patients with transthyretin (TTR) mediated amyloidosis (ATTR).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Alnylam Pharmaceuticals

Criteria

Inclusion Criteria:

• Previously received and tolerated ALN-TTR02 (patisiran) in Study ALN-TTR02-002.

• Adequate Karnofsky performance status, liver function, and renal function.

Exclusion Criteria:

• Pregnant or nursing.

• Has had a liver transplant.

• Has a New York Heart Association heart failure classification >2.

• Has unstable angina.

• Has uncontrolled clinically significant cardiac arrhythmia.