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Transthyretin Stabilizer

Acoramidis for Amyloid Cardiomyopathy

Phase 3

Waitlist Available

Research Sponsored by Eidos Therapeutics, a BridgeBio company

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Female participants of childbearing potential who engage in heterosexual intercourse must agree to use a highly effective method of contraception beginning with enrollment and continuing for 30 days after the last dose of acoramidis. Female participants using oral contraceptives must agree to use an additional birth control method. While not considered highly effective, a double-barrier method is acceptable. A male participant who is sexually active with a female of childbearing potential and has not had a vasectomy must agree to use a double-barrier method of birth control

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 60 months

Awards & highlights

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.

Who is the study for?

This trial is for people who finished the AG10-301 study, understand and can sign consent forms, and agree to use effective birth control. It's not for those with certain medical conditions or sensitivities, recent heart issues or strokes, kidney problems, other clinical trials within 30 days, substance abuse history, psychiatric conditions that affect compliance, mechanical heart devices or transplants.Check my eligibility

What is being tested?

The trial tests Acoramidis (AG10) in patients with Transthyretin Amyloid Cardiomyopathy who completed a previous Phase 3 trial. It's an open-label extension meaning everyone knows they're getting AG10 and it focuses on long-term safety monitoring of the drug.See study design

What are the potential side effects?

While specific side effects are not listed here, participants will be monitored for any adverse reactions due to Acoramidis (AG10), which could include typical drug-related side effects such as allergic reactions or issues related to its impact on amyloid cardiomyopathy.

Eligibility Criteria

Inclusion Criteria

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

Select...

I agree to use effective birth control during and 30 days after the trial.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 60 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~60 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 60 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Incidence of treatment-emergent Adverse Events [Safety and Tolerability]

Secondary outcome measures

Evaluate all-cause mortality and cardiovascular mortality

Evaluate the effect of acoramidis on health-related quality of life Kansas City Cardiomyopathy Questionnaire

Evaluate the effect of acoramidis on the 6-minute walk test (6MWT)

+1 more

Trial Design

1Treatment groups

Experimental Treatment

Group I: AG10Experimental Treatment1 Intervention

Open-label study all participants will receive AG10 during this study.

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

Eidos Therapeutics, a BridgeBio companyLead Sponsor

9 Previous Clinical Trials

1,346 Total Patients Enrolled

2 Trials studying Amyloid Cardiomyopathy

687 Patients Enrolled for Amyloid Cardiomyopathy

Media Library

Acoramidis (AG10) (Transthyretin Stabilizer) Clinical Trial Eligibility Overview. Trial Name: NCT04988386 — Phase 3

Amyloid Cardiomyopathy Research Study Groups: AG10

Amyloid Cardiomyopathy Clinical Trial 2023: Acoramidis (AG10) Highlights & Side Effects. Trial Name: NCT04988386 — Phase 3

Acoramidis (AG10) (Transthyretin Stabilizer) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04988386 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What are the dangers of taking Acoramidis (AG10)?

"There is both efficacy and safety data supporting AG10, so it received a score of 3."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Open-Label Safety Study of Acoramidis (AG10) in Symptomatic ATTR Participants

2021. "Open-Label Safety Study of Acoramidis (AG10) in Symptomatic ATTR Participants". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04988386.

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