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Vutrisiran for Transthyretin Amyloidosis with Cardiomyopathy
Study Summary
This trial will test if vutrisiran, given every 3 months, is better than placebo at treating ATTR amyloidosis with heart problems.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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Who is running the clinical trial?
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- I have been hospitalized for heart failure before or show signs of it.I have been diagnosed with primary or leptomeningeal amyloidosis.I have a heart condition not caused by TTR amyloidosis.I have been diagnosed with a type of heart disease caused by transthyretin amyloidosis.I have severe nerve damage affecting my daily activities.I have been treated before to lower TTR levels.I have the most severe form of heart failure.I have severe heart failure and am considered high risk.My kidney function is severely reduced.
- Group 1: Placebo
- Group 2: Vutrisiran 25 mg
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
Does this experiment allow octogenarians as volunteers?
"According to the study's eligibility requirements, patients between 18 and 85 years old may apply. There are 246 similar studies for individuals outside of this age range."
Which type of person would be best suited for this clinical trial?
"Patients with amyloid neuropathies who come from families with a history of the condition are eligible for this trial if they are between 18 and 85 years old. A total of 655 patients can take part in this study."
Is Vutrisiran a new medication or have their been other studies with this drug?
"There are currently two Vutrisiran clinical trials underway, both in Phase 3. The majority of the 158 total trial sites for this treatment are located in Houston, Texas."
What is the uniqueness of this trial in relation to others?
"As of now, there are 2 ongoing studies for Vutrisiran in 24 different cities and 39 nations. The first trial was completed in 2019 by Alnylam Pharmaceuticals. That initial study had 164 participants and finished Phase 3 drug approval. In the years since, 17 more similar studies have been conducted."
Are there any research facilities in North America testing this medication?
"Right now, medical professionals are looking for patients to participate in this clinical trial from 17 different hospitals. If you choose to partake in the study, it would be best to select a location near you so that travelling isn't too much of an inconvenience. The locations recruiting patients include Boston, Quebec City and Toronto as well as 14 other cities."
When might Vutrisiran be available for public use?
"Vutrisiran is rated as a 3 in terms of safety by our team at Power. This is due to this being a Phase 3 trial, which provides some evidence for efficacy and multiple rounds of supporting data for safety."
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