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Tests treatment safety and results for Transthyretin-type Cardiac Amyloidosis
Official title Real-Life Clinical Efficacy of Acoramidis in Participants With ATTR-CM and Association With Cardiac Biomarkers
ClinicalTrials.gov ID: NCT07306949
What this study is testing
What is Acoramidis?
Acoramidis is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for transthyretin-type cardiac amyloidosis.
Also referred to as acoramidis hydrochloride Byontra.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The purpose of this study is to confirm that the treatment with acoramidis prevents the deterioration of the ATTR-CM disease progression index and that these indexes are surrogate markers of disease progression.
- Phase 4: studies an already-approved treatment
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 100
You may be able to join if
- Treatment history of ATTR-CM is one of the following:
- Naive participants: newly diagnosed with ATTR-CM and no prior treatment with drugs for ATTR-CM
- Switch participants: Participants who are using tafamidis, a TTR stabilizer, as treatment for ATTR-CM and who, in the judgment of the post-marketing...
- Naive participants must meet the following requirements:
- History of hospitalization for heart failure or heart failure symptoms requiring treatment, including diuretics
You likely can't join if
- Have confirmed diagnosis of AL amyloidosis
- Switch participants: prior treatment with gene silencing agents (pachysilane sodium, butrisilane sodium) as treatment for ATTR-CM (including when...
- Likelihood of receiving a heart transplant within 1 year from the time screening begins
- Hypersensitivity to acoramidis, its metabolites, or additives in the formulation has been confirmed.
- Pregnant or lactating women
- Has a clinically significant medical condition, an abnormal laboratory test result, or a condition that may jeopardize the safety of the study...
See the full eligibility criteria
- Treatment history of ATTR-CM is one of the following:
- Naive participants: newly diagnosed with ATTR-CM and no prior treatment with drugs for ATTR-CM
- Switch participants: Participants who are using tafamidis, a TTR stabilizer, as treatment for ATTR-CM and who, in the judgment of the post-marketing clinical trial investigator (co-principal investigator), can be...
- Naive participants must meet the following requirements:
- History of hospitalization for heart failure or heart failure symptoms requiring treatment, including diuretics
- Echocardiographic end-diastolic ventricular septal thickness greater than 12 millimeters (mm)
- Confirmed diagnosis of ATTR-CM (wild type or mutant) by one of the following diagnostic methods
- Tissue biopsy shows amyloid deposition and TTR precursor protein is identified by immunohistochemistry or mass spectrometry.
- Bone scintigraphy showing strong accumulation \ \ (Perugini score ≥ 2) consistent with myocardium and no M protein, negating the possibility of AL amyloidosis
- Have confirmed diagnosis of AL amyloidosis
- Switch participants: prior treatment with gene silencing agents (pachysilane sodium, butrisilane sodium) as treatment for ATTR-CM (including when specifically scheduled to start treatment with a gene silencing agent)
- Likelihood of receiving a heart transplant within 1 year from the time screening begins
- Hypersensitivity to acoramidis, its metabolites, or additives in the formulation has been confirmed.
- Pregnant or lactating women
- Has a clinically significant medical condition, an abnormal laboratory test result, or a condition that may jeopardize the safety of the study participant, increase the risk of participation in the post-marketing...
- Participating in an treatment study other than this study, including a clinical trial
- In the opinion of the responsible (sub)physician for the post-marketing clinical trial, has a history of drug abuse, alcoholism, or psychiatric disorder that would preclude compliance with this Post-Marketing Clinical...
The study team makes the final eligibility decision.
Where it's taking place
- Bunkyō City, Japan
- Kumamoto, Japan
- Kurume-shi, Japan
- Kyoto, Japan
- Mitaka-shi, Japan
- Nagoya, Japan
- Nankoku-shi, Japan
- Okayama, Japan
- Ōtsu, Japan
- Sagamihara-shi, Japan
- Sapporo, Japan
- Shinjuku-ku, Japan
- Suita-shi, Japan
- Tsu, Japan
- Yufu-shi, Japan
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 100 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Bunkyō City, Japan; Kumamoto, Japan; Kurume-shi, Japan; Kyoto, Japan; Mitaka-shi, Japan; Nagoya, Japan and 9 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.