Status:
TERMINATED
A Study to Characterize Adverse Events Occurring Within One Day of TEGSEDI Administration to Adult Participants With hATTR-PN
Lead Sponsor:
Akcea Therapeutics
Conditions:
Hereditary Transthyretin Amyloidosis With Polyneuropthy
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
The objective of the study was to characterize adverse events (AEs) occurring within one day of TEGSEDI administration to adult participants with hATTR-PN overall and in individual participants with r...
Eligibility Criteria
Inclusion
- Satisfy one of the following:
- United States (US) Participants: Adult participants (≥ 18 years old) diagnosed with hATTR-PN and prescribed TEGSEDI according to the United States Prescribing Information (USPI).
- Canadian participants: Adult participants (≥ 18 years old) diagnosed with stage 1 or stage 2 hATTR-PN and prescribed TEGSEDI according to the Canadian Product Monograph (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, participant 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, participant is utilizing an acceptable contraceptive method from the time of signing the ICF until 13 weeks after the last dose of TEGSEDI administration
Exclusion
- None
Key Trial Info
Start Date :
January 21 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 20 2024
Estimated Enrollment :
8 Patients enrolled
Trial Details
Trial ID
NCT04306510
Start Date
January 21 2021
End Date
March 20 2024
Last Update
April 10 2025
Active Locations (2)
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1
Study Center
Rosedale, New York, United States, 11422
2
Study Center
Toronto, Ontario, Canada, M3K0A6