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RNAi Therapeutics

Vutrisiran 25 mg for Amyloid Cardiomyopathy

Phase 3
Waitlist Available
Research Sponsored by Alnylam Pharmaceuticals
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
* 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
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 36 months
Awards & highlights
No Placebo-Only Group
Pivotal Trial

Summary

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.

Who is the study for?
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.
What is being tested?
The 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.
What are the potential side effects?
While specific side effects are not listed here, treatments like Vutrisiran may cause reactions at the injection site, nausea, fatigue, or abnormal liver function tests. Side effects can vary widely among individuals.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 36 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 36 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Frequency of Adverse Events (AEs)
Secondary study objectives
All-Cause Mortality and Recurrent Cardiovascular (CV) Events (CV Hospitalizations and Urgent Heart Failure [HF] Visits)
Change From Baseline in the Cardiac Biomarker: N-terminal Prohormone of B-type Natriuretic Peptide (NT-proBNP)
Change From Baseline in the Cardiac Biomarker: Troponin I
+2 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

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 Location

Who is running the clinical trial?

Alnylam PharmaceuticalsLead Sponsor
79 Previous Clinical Trials
15,376 Total Patients Enrolled
Medical DirectorStudy DirectorAlnylam Pharmaceuticals
2,882 Previous Clinical Trials
8,088,346 Total Patients Enrolled
~533 spots leftby Jun 2028
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