Amyloid Cardiomyopathy, Transthyretin-Related Clinical Trial
Official title:
An Open-Label Extension and Safety Monitoring Study of Acoramidis (AG10) in Participants With Symptomatic Transthyretin Amyloid Cardiomyopathy Who Completed the Phase 3 ATTRibute-CM Trial (AG10-301)
Open-Label Extension and Safety Monitoring Study of Acoramidis (AG10) in Participants with Symptomatic Transthyretin Amyloid Cardiomyopathy Who Completed the Phase 3 ATTRibute-CM Trial (AG10-301)
The primary objective of this prospective multi-center, open-label study is to evaluate the long-term safety and tolerability of acoramidis in the context of background heart failure therapy. Selected secondary efficacy endpoints and exploratory pharmacokinetic, pharmacodynamic/biomarker endpoints may also be assessed. All participants who complete 30 months of blinded study treatment and the Month 30 assessments of the double-blind treatment period of the Phase 3 ATTRibute-CM trial (AG10-301) may be eligible to participate in this Open Label Extension (OLE) study of acoramidis. The Day 1 visit in Study AG10-304 may be the same day as the Month 30 visit in Study AG10-301. Under these circumstances, the last dose of Investigational Medicinal Product (IMP) in Study AG10-301 will be the night before the day of the Month 30 visit and the first dose of acoramidis in Study AG10-304 will be during the Study AG10-304 Day 1 visit after baseline assessments have been completed. Currently, tafamidis is approved for the treatment of ATTR-CM in some regions. Participants are not allowed to be treated with tafamidis or any other ATTR-CM-specific approved or investigational treatments, or therapies used off-label or as non-prescription supplements for ATTR-CM at any time during the study. If participants choose treatment with a prohibited medication, they may be asked to discontinue acoramidis and they may be asked to discontinue/withdraw from the study. Under these circumstances, participants will be asked to complete an early termination visit, and a follow-up visit prior to discontinuation/withdrawal. Participants are not permitted to participate in another interventional clinical trial (with the exception of Study AG10-301) within 30 days prior to dosing and throughout Study AG10-304. Participants who choose to participate in another interventional clinical trial may be asked to withdraw from acoramidis and/or the study. In such cases, participants will be asked to complete an early termination visit and a follow-up visit. Participation in observational and/or registry studies should be discussed with the Medical Monitor. ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT03294707 -
Single and Multiple Ascending Dose Study Assessing the Safety, Tolerability, PK and PD of AG10
|
Phase 1 | |
| Recruiting |
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