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Clinical trial

Tafamidis 61mg, Resultados en Amiloidosis ATTR Con afectación neurológica y Multisistémica - TRAMA

ID
Name
B3461104
Description
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/ophtalmo/gastrointestinal) ≥12 months.
Trial arms
Trial start
2022-10-24
Estimated PCD
2022-11-15
Trial end
2022-11-15
Status
Completed
Treatment
Tafamidis
61 milligrams (mg) as received in studies B3461028 and B3461045
Arms:
Retrospective cohort ATTRv and ATTRwt patients enrolled in B3461028 and B3461045 studies in Spain
Size
5
Primary endpoint
Change from Baseline in Neurological Impairment score (NIS)
Baseline, Month 12
Eligibility criteria
Inclusion Criteria: * Treatment with tafamidis 61 mg ≥ 12 months * Neurological follow up ≥ 12 months * Diagnosis of transthyretin amyloidosis with polyneuropayhy (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 Sudoscan, RR Interval análisis, etc..) Exclusion Criteria: * Treatment with tafamidis 61 mg \< 12 months * Neurological follow up \< 12 months * Other diagnosis for polyneuropathy
Protocol
{'studyType': 'OBSERVATIONAL', 'patientRegistry': False, 'designInfo': {'observationalModel': 'OTHER', 'timePerspective': 'RETROSPECTIVE'}, 'enrollmentInfo': {'count': 5, 'type': 'ACTUAL'}}
Updated at
2022-12-27

1 organization

1 product

2 indications

Organization
Pfizer
Product
Tafamidis
Indication
Hereditary Transthyretin Amyloidosis
Indication
Polyneuropathy