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Retrospective Study Collecting Neurological Follow-up of Hereditary Transthyretin Amyloidosis (ATTRv) Patients Included in B3461028 and B3461045.

NCT05560555

CompletedN/A

Sponsor: Pfizer

Conditions: Hereditary Transthyretin Amyloidosis (ATTRv), Polyneuropathy

Interventions: Tafamidis

Countries: Spain

A study of patients with hereditary transthyretin amyloidosis (ATTRv) and wild-type transthyretin amyloidosis (ATTRwt) that have been enrolled in B3461028 and B3461045 studies in Spain - exposed to tafamidis 61mg for ≥12 months with polyneuropathy (PN) have kept going to their multisystemic follow-ups (neuro/ophthalmo/gastrointestinal) ≥12 months.

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: OBSERVATIONAL

Eligibility criteria

Inclusion Criteria:

* Treatment with tafamidis 61 mg ≥ 12 months
* Neurological follow up ≥ 12 months
* Diagnosis of transthyretin amyloidosis with polyneuropathy (ATTR-PN) based on one of the following:
* Amplitude reduction in, at least, 2 nerves under normal value, excluding median nerve OR 50% amplitude reduction in, at least, 2 nerves on the basal value of the patient, excluding median nerve OR 2 abnormal tests detecting thin fibers alterations (through Sudo scan, RR Interval analysis, etc..)

Exclusion Criteria:

* Treatment with tafamidis 61 mg \< 12 months
* Neurological follow up \< 12 months
* Other diagnosis for polyneuropathy

Locations (3)

Barcelona, Spain
Madrid, Spain
Palma de Mallorca, Spain