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

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Pfizer

Status

Active, not recruiting

Conditions

Transthyretin Amyloidosis Cardiomyopathy (ATTR-CM)

Treatments

Drug: Tafamidis

Study type

Observational

Funder types

Industry

Identifiers

NCT06393465
B3461121

Details and patient eligibility

About

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

Enrollment

50 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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 once daily for ≥12 months.
  • Have had ≥1 pre- and ≥1 post-treatment neurologic assessments.

Exclusion criteria

  • History of any organ transplant.
  • Individuals who are non-ambulatory.
  • Prior or current treatment with any disease-modifying therapy (investigational or approved) alone or in combination, except tafamidis, as VYNDAQEL 80 mg [four 20-mg tafamidis meglumine capsules] orally once daily or VYNDAMAX 61 mg [one 61-mg tafamidis capsule] orally once daily.
  • Peripheral neuropathy attributed to causes other than ATTR amyloidosis (eg, diabetes mellitus, B12 deficiency, hypothyroidism, shingles,Lyme disease, HIV infection, secondary to injury, chronic kidney disease).
  • Patient's data fails to pass data quality checks.

Trial design

50 participants in 1 patient group

Patients with mixed phenotype ATTR-CM
Description:
ATTR-CM patients presenting with mixed phenotype
Treatment:
Drug: Tafamidis

Trial contacts and locations

1

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Central trial contact

Pfizer CT.gov Call Center

Data sourced from clinicaltrials.gov

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