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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
90 Years
Healthy volunteers
No
Inclusion Criteria:
1. Completed participation in study AG10-201.
2. Willing and able to comply with the study medication regimen and all study requirements.
3. The ability to understand and provide informed consent, which must be obtained prior to initiation of study participation.
4. Male patients and female patients of childbearing potential who engage in heterosexual intercourse must agree to use effective method(s) of contraception.
Exclusion Criteria:
1. Hemodynamic instability that would pose too great a risk to the subject.
2. Abnormalities in clinical laboratory tests that would pose too great a risk to the subject.
3. Any clinically significant ongoing medical condition or any laboratory abnormality or condition that could adversely affect the safety of the patient.
4. Known hypersensitivity to study drug (AG10), its metabolites, or formulation excipients.
5. Likely to undergo heart transplantation or placement of a mechanical circulatory device within the next year.
6. 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.
7. Females who are pregnant or breastfeeding. Lactating females must agree to discontinue nursing before the study drug is administered.
Primary outcome measure(s)
Assessment of long-term safety and tolerability: Incidence of each treatment-emergent adverse events — up to 60 Months or study completion by recommendation from safety monitoring committee Incidence of each treatment-emergent adverse events
Trial sites (9)
Facility
City
Region
Status
Stanford University
Palo Alto
California
University of California San Francisco
San Francisco
California
Yale University
New Haven
Connecticut
Northwestern University
Chicago
Illinois
Brigham and Women's Hospital
Boston
Massachusetts
Mayo Clinic
Rochester
Minnesota
Columbia University
New York
New York
Oregon Health & Science University
Portland
Oregon
Medical University of South Carolina
Charleston
South Carolina
More Eidos Therapeutics, a BridgeBio company trials in the USA
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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