Open-Label Study of AG10 in Patients with Cardiomyopathy

Launched by EIDOS THERAPEUTICS, A BRIDGEBIO COMPANY · May 23, 2018

Keywords

ClinConnect Summary

This clinical trial, called the AG10 study, is investigating the long-term safety and effectiveness of a medication called AG10 for patients with a specific heart condition known as amyloid cardiomyopathy. This condition affects the heart's ability to function properly due to the buildup of abnormal proteins. The study is currently active but not recruiting new participants. It aims to help researchers understand how AG10 works when taken alongside other stable heart failure treatments.

To be eligible for this study, participants must have previously completed another related study (AG10-201), be able to follow the medication schedule, and understand what participation involves. Both men and women can join, but women of childbearing age must agree to use effective birth control. Participants should be generally healthy and not have serious ongoing medical issues that could make taking the study drug unsafe. Throughout the study, participants will be closely monitored to ensure their safety and to collect important information about how AG10 affects their condition.

Gender

ALL

Eligibility criteria

• 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.