Vutrisiran for Amyloid Cardiomyopathy
Recruiting at 71 trial locations
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 3
Waitlist Available
Sponsor: Alnylam Pharmaceuticals
No Placebo Group
Pivotal Trial (Near Approval)
Prior Safety Data
Trial Summary
What is the purpose of this trial?
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.
Research Team
MD
Medical Director
Principal Investigator
Alnylam Pharmaceuticals
Eligibility Criteria
This trial is for patients with a heart condition called Transthyretin Amyloidosis with Cardiomyopathy. It's not specified, but typically participants should be adults who meet certain health standards and have the specific medical condition being studied.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
Treatment Details
Interventions
- Vutrisiran (RNAi Therapeutics)
Trial OverviewThe study is testing Vutrisiran, a medication aimed at treating Transthyretin Amyloidosis with Cardiomyopathy. The trial will assess its safety and effectiveness, including how it affects the body over an extended period or when switching from another drug, patisiran.
Participant Groups
1Treatment groups
Experimental Treatment
Group I: Vutrisiran 25 mgExperimental Treatment1 Intervention
Participants will receive vutrisiran 25 mg administered subcutaneously (SC) once every 3 months (q3M).
Find a Clinic Near You
Who Is Running the Clinical Trial?
Alnylam Pharmaceuticals
Lead Sponsor
Trials
81
Recruited
16,100+
Dr. Yvonne Greenstreet
Alnylam Pharmaceuticals
Chief Executive Officer since 2021
MD from the University of Leeds, MBA from INSEAD
Dr. Pushkal Garg
Alnylam Pharmaceuticals
Chief Medical Officer since 2016
MD from Columbia University