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Acoramidis for Amyloid Cardiomyopathy
Study Summary
This trial is for people with Transthyretin Amyloid Cardiomyopathy who completed the Phase 3 ATTRibute-CM Trial. The purpose is to see if the drug is safe and works well.
Timeline
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 am not taking any medications that are not allowed in the study.I have been diagnosed with AL amyloidosis.I agree to use effective birth control during and 30 days after the trial.I have not had a heart attack, stroke, or heart surgery in the last 3 months.You have had a heart pump implanted or are scheduled to have one implanted.Your kidney function, as measured by eGFR, is too low.You are allergic to acoramidis or any of the ingredients in the medication.I have had a heart or liver transplant, or I am on the heart transplant list.
- Group 1: AG10
- 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.
- 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
What are the dangers of taking Acoramidis (AG10)?
"There is both efficacy and safety data supporting AG10, so it received a score of 3."
Would elderly patients be able to participate in this trial?
"According to the study's inclusion criteria, patients aged 18 to 90 are eligible for enrolment. In contrast, there are 16 trials specifically for individuals under 18 and 245 studies seeking participants that are over 65."
Are there any other facilities conducting this research within the state?
"The trial is currently being conducted at 56 different sites. The locations are located in New Haven, Rosedale and Aurora as well as 56 other locations. It is helpful to select the site nearest you to minimize travel demands if you participate."
Is this research still looking for participants?
"Unfortunately, this specific trial is no longer recruiting new patients. It was originally posted on October 27th 2021 but the most recent update occurred on March 21st, 2022. That being said, there are 253 other trials with open recruitment at present."
Which patients would be an ideal fit for this clinical trial?
"This study is for 545 individuals aged 18 to 90 who have familial amyloid cardiomyopathy caused by a transthyretin mutation. All patients must also have completed 30 months of treatment in Study AG10-301, including the Month 30 visit and associated assessments and procedures."
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