Real-World Effectiveness of High-Dose Tafamidis on Neurologic Disease Progression in Mixed-Phenotype Transthyretin Amyloid Cardiomyopathy

Last updated: May 5, 2025
Sponsor: Pfizer
Overall Status: Active - Not Recruiting

Phase

N/A

Condition

Circulation Disorders

Amyloidosis

Neurologic Disorders

Treatment

Tafamidis

Clinical Study ID

NCT06393465
B3461121
  • Ages > 18
  • All Genders

Study Summary

This study will examine the clinical effectiveness of Tafamidis in patients with Mixed Phenotype Transthyretin Amyloidosis using data that already exist in patients' medical records

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Age ≥18 years at diagnosis.

  • Diagnosed with ATTRv-CM or ATTRwt-CM, mixed phenotype.

  • Treated with tafamidis, as VYNDAMAX 61 mg (one 61-mg tafamidis capsule) orally oncedaily for ≥12 months or started on tafamidis 20 mg then switched to VYNDAMAX 61 mgfor ≥12 months

  • Have had ≥1 pre- and ≥1 post-treatment neurologic assessments.

Exclusion

Exclusion Criteria:

  • History of any organ transplant.

  • Individuals who are non-ambulatory.

  • Prior or current treatment with any disease-modifying therapy (investigational orapproved) alone or in combination, except tafamidis, as VYNDAQEL 80 mg [four 20-mgtafamidis meglumine capsules] orally once daily or VYNDAMAX 61 mg [one 61-mgtafamidis capsule] orally once daily.

  • Peripheral neuropathy attributed to causes other than ATTR amyloidosis (eg, diabetesmellitus, B12 deficiency, hypothyroidism, shingles,Lyme disease, HIV infection,secondary to injury, chronic kidney disease).

  • Patient's data fails to pass data quality checks.

Study Design

Total Participants: 50
Treatment Group(s): 1
Primary Treatment: Tafamidis
Phase:
Study Start date:
June 15, 2024
Estimated Completion Date:
June 30, 2025

Connect with a study center

  • Pfizer

    New York, New York 10001
    United States

    Site Not Available

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