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 range18 Years – 90 Years

SexALL

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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.
✕. 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.

What they're measuring

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

Trial details

NCT IDNCT03536767

SponsorEidos Therapeutics, a BridgeBio company

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2027-07

View on ClinicalTrials.gov More Amyloid Cardiomyopathy trials