Open-Label Study of AG10 in Patients with Cardiomyopathy (NCT03536767) | Clinical Trial Compass
Active — Not RecruitingPhase 2
Open-Label Study of AG10 in Patients with Cardiomyopathy
United States55 participantsStarted 2018-08-08
Plain-language summary
This prospective, multicenter open-label study will evaluate the long-term safety, tolerability, PK and PD of AG10 administered on a background of stable heart failure therapy.
Who can participate
Age range
18 Years – 90 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Completed participation in study AG10-201.
. Willing and able to comply with the study medication regimen and all study requirements.
. The ability to understand and provide informed consent, which must be obtained prior to initiation of study participation.
. Male patients and female patients of childbearing potential who engage in heterosexual intercourse must agree to use effective method(s) of contraception.
Exclusion criteria
. Hemodynamic instability that would pose too great a risk to the subject.
. Abnormalities in clinical laboratory tests that would pose too great a risk to the subject.
. Any clinically significant ongoing medical condition or any laboratory abnormality or condition that could adversely affect the safety of the patient.
. Known hypersensitivity to study drug (AG10), its metabolites, or formulation excipients.
. Likely to undergo heart transplantation or placement of a mechanical circulatory device within the next year.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Assessment of long-term safety and tolerability: Incidence of each treatment-emergent adverse events
Timeframe: up to 60 Months or study completion by recommendation from safety monitoring committee
. Receiving current treatment with diflunisal, tafamidis, green tea, doxycycline, TUDCA/Ursodiol, patisiran, inotersen or any other investigational ATTR agent within 14 days or 5 half-lives of the prior investigational agent (whichever is longer) prior to dosing with study drug.
. Females who are pregnant or breastfeeding. Lactating females must agree to discontinue nursing before the study drug is administered.