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)
Completed · Phase 2
Conditions studied: TTR-mediated Amyloidosis
In brief
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).
Key facts
- Study ID
- NCT01961921
- Run by
- Alnylam Pharmaceuticals
- People needed
- 27
- Starts
- 2013-10-01
- Expected to finish
- 2016-08-01
- Last updated by the study team
- 2024-04-19
Who can join
Age: 18 and older, up to 85. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Previously received and tolerated ALN-TTR02 (patisiran) in Study ALN-TTR02-002.
- Adequate Karnofsky performance status, liver function, and renal function.
You may not qualify if…
- 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.
Where it is running
- Clinical Trial Site — Boston, Massachusetts, United States
- Clinical Trial Site — Rio de Janeiro, Brazil
- Clinical Trial Site — Le Kremlin-Bicêtre, France
- Clinical Trial Site — Marseille, France
- Clinical Trial Site — Münster, Germany
- Clinical Trial Site — Lisbon, Portugal
- Clinical Trial Site — Porto, Portugal
- Clinical Trial Site — Palma de Mallorca, Spain
- Clinical Trial Site — Umeå, Sweden
Full record on ClinicalTrials.gov
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