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Clinical Trials in Japan / NCT07306949
Recruiting Phase 4

Real-Life Clinical Efficacy of Acoramidis in Participants With ATTR-CM and Association With Cardiac Biomarkers

NCT07306949 · tracked via the Priya Life Science Japan tracker
Phase
Phase 4
Started
2025-10-01
Last updated
2026-01-07

Condition(s) studied

Transthyretin-type Cardiac Amyloidosis

Investigational drug(s) / intervention(s)

Acoramidis →

Acoramidis: Participants will receive acoramidis tablets orally.

Study summary

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
100 Years
Healthy volunteers
No
Inclusion 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 expected to benefit from switching to acoramidis. * Naive participants must meet the following requirements: 1. History of hospitalization for heart failure or heart failure symptoms requiring treatment, including diuretics 2. Echocardiographic end-diastolic ventricular septal thickness greater than 12 millimeters (mm) 3. Confirmed diagnosis of ATTR-CM (wild type or mutant) by one of the following diagnostic methods 1. Tissue biopsy shows amyloid deposition and TTR precursor protein is identified by immunohistochemistry or mass spectrometry. 2. Bone scintigraphy showing strong accumulation \*\* (Perugini score ≥ 2) consistent with myocardium and no M protein, negating the possibility of AL amyloidosis Exclusion Criteria: * 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 clinical trial, or affect the study * Participating in an interventional 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 Study Protocol

Primary outcome measure(s)

Trial sites (16)

FacilityCityRegionStatus
Research Site Bunkyō City Japan Not Yet Recruiting
Research Site Bunkyō City Japan Not Yet Recruiting
Research Site Kumamoto Japan Not Yet Recruiting
Research Site Kurume-shi Japan Recruiting
Research Site Kyoto Japan Not Yet Recruiting
Research Site Mitaka-shi Japan Not Yet Recruiting
Research Site Nagoya Japan Not Yet Recruiting
Research Site Nankoku-shi Japan Not Yet Recruiting
Research Site Okayama Japan Not Yet Recruiting
Research Site Ōtsu Japan Not Yet Recruiting
Research Site Sagamihara-shi Japan Not Yet Recruiting
Research Site Sapporo Japan Not Yet Recruiting
Research Site Shinjuku-ku Japan Not Yet Recruiting
Research Site Suita-shi Japan Not Yet Recruiting
Research Site Tsu Japan Not Yet Recruiting
Research Site Yufu-shi Japan Recruiting

More Alexion Pharmaceuticals, Inc. trials in Japan

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07306949 on ClinicalTrials.gov ↗ ← All trials in Japan