An Open-Label Extension Study to Assess the Safety and Efficacy of Vutrisiran in Patients With Transthyretin Amyloidosis With Cardiomyopathy (ATTR Amyloidosis With Cardiomyopathy)
N
Noel Dasgupta
Primary Investigator
Enrolling By Invitation
18 years or above
All
Phase
N/A
7 participants needed
1 Location
Brief description of study
What is the purpose of this study?
The purpose of this study is to obtain safety, efficacy, and pharmacodynamic data on the use of vutrisiran in patients with ATTR amyloidosis with cardiomyopathy who continued on extended use of vutrisiran, or switched from patisiran.
THIS STUDY IS ENROLLING BY INVITATION ONLY - This study is only enrolling individuals who have been participating in the patisiran parent studies ALN-TTR02-011 or ALN-TTR02-014 or who have completed the 24-month OLE Period in the vutrisiran parent study ALN-TTRSC02-003
Detailed description of study
What will happen during the study?
Participants will receive vutrisiran 25 mg administered subcutaneously (SC) once every 3 months (q3M).
Eligibility of study
You may be eligible for this study if you meet the following criteria:
- Conditions: Transthyretin Amyloidosis (ATTR) With Cardiomyopathy
-
Age: 18 years or above
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Gender: All
Inclusion Criteria:
- Patients who are participating in the patisiran parent studies ALN-TTR02-011 or ALN-TTR02-014 or who have completed the 24-month OLE Period in the vutrisiran parent study ALN-TTRSC02-003
Exclusion Criteria:
- Has permanently discontinued study drug administration while participating in the parent studies, ALN-TTR02-011, ALN-TTR02-014, or ALN-TTRSC02-003
- Future or current participation in another investigational device or drug study, scheduled to occur during this study
- Has other medical conditions or comorbidities which, in the opinion of the Investigator, would interfere with study compliance or data interpretation
Updated on
22 Apr 2025.
Study ID: PATH-ALNYLAM-VUTRISIRAN, 24994
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