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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

5 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-10-24

Study Completion Date

2022-11-15

Brief Summary

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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.

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Detailed Description

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Conditions

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Hereditary Transthyretin Amyloidosis (ATTRv) Polyneuropathy

Study Design

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Observational Model Type

OTHER

Study Time Perspective

RETROSPECTIVE

Study Groups

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Retrospective cohort ATTRv and ATTRwt patients enrolled in B3461028 and B3461045 studies in Spain

Tafamidis

Intervention Type DRUG

61 milligrams (mg) as received in studies B3461028 and B3461045

Interventions

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Tafamidis

61 milligrams (mg) as received in studies B3461028 and B3461045

Intervention Type DRUG

Eligibility Criteria

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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..)