Transthyretin Amyloid Cardiomyopathy Clinical Trial
A Clinical Study to Characterize Adverse Events Occurring Within One Day of TEGSEDI Administration to Adult Patients With hATTR-PN
Summary
The objective of the study is to characterize adverse events (AEs) occurring within one day of TEGSEDI administration to adult patients with hATTR-PN overall and in individual patients with respect to time course of AE onset, vital sign changes, preventive measures, treatment required, risk factors, and subsequent adverse outcomes.
Eligibility Criteria
Inclusion Criteria:
Satisfy one of the following:
US Patients: Adult patients (≥ 18 years old) diagnosed with hATTR-PN and prescribed TEGSEDI according to the USPI
Canadian Patients: Adult patients (≥ 18 years old) diagnosed with stage 1 or stage 2 hATTR PN and prescribed TEGSEDI according to the CPM
Must have given written informed consent for participation in this study
Must provide access to their previous medical records
Are about to initiate or have recently initiated treatment with TEGSEDI and have not received more than 9 doses in total
Be willing to complete required testing and report any AEs and/or changes in medications
Satisfy one of the following:
Females: Non-pregnant and non-lactating; abstinent, or if engaged in sexual relations of childbearing potential, patient is using an acceptable contraceptive method from time of signing the informed consent form (ICF) until 13 weeks after the last dose of TEGSEDI administration
Males: Abstinent or if engaged in sexual relations with a female of childbearing potential, patient is utilizing an acceptable contraceptive method from the time of signing the ICF until 13 weeks after the last dose of TEGSEDI administration
Exclusion Criteria:
None
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There are 2 Locations for this study
Rosedale New York, 11422, United States
Toronto Ontario, M3K0A, Canada
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