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(23026) A prospective, single-arm, Phase 4 study to evaluate the course of serum transthyretin (TTR) level with acoramidis in adult patients with variant or wild-type transthyretin amyloidosis with cardiomyopathy (ATTR-CM) previously treated with tafamidis.

Status
Not yet recruiting
Phases
Phase 4
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2025-521831-35-00
Enrollment
32
Registered
2026-02-07
Start date
Unknown
Completion date
Unknown
Last updated
2026-02-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Transthyretin Amyloid Cardiomyopathy (ATTR-CM)

Brief summary

Change in serum TTR level from baseline to month 6 or premature discontinuation of treatment

Detailed description

Serum TTR level at baseline, week 1, 2, 3, 4 and at month 3., Occurrence of TEAEs and type of TEAEs and serious TEAEs., Change from baseline to month 6 of NT-proBNP, hs-TnT, hs-CRP, RBP4., Signs of remodeling from baseline to month 6 in ECHO., Change from baseline to month 6 in 6MWD, Change from baseline to month 6 in kidney and thyroid biomarkers: eGFR, Creatinine, Cystatin C, UACR, and TSH., Change from baseline to month 6 in KCCQ-OS score and in EQ-5D-5L index score.

Interventions

Sponsors

Bayer Consumer Care AG
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
Change in serum TTR level from baseline to month 6 or premature discontinuation of treatment

Secondary

MeasureTime frame
Serum TTR level at baseline, week 1, 2, 3, 4 and at month 3., Occurrence of TEAEs and type of TEAEs and serious TEAEs., Change from baseline to month 6 of NT-proBNP, hs-TnT, hs-CRP, RBP4., Signs of remodeling from baseline to month 6 in ECHO., Change from baseline to month 6 in 6MWD, Change from baseline to month 6 in kidney and thyroid biomarkers: eGFR, Creatinine, Cystatin C, UACR, and TSH., Change from baseline to month 6 in KCCQ-OS score and in EQ-5D-5L index score.

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 10, 2026