Open-Label Safety Study of Acoramidis (AG10) in Symptomatic ATTR Participants (NCT04988386) | Clinical Trial Compass
Active — Not RecruitingPhase 3
Open-Label Safety Study of Acoramidis (AG10) in Symptomatic ATTR Participants
United States389 participantsStarted 2021-10-27
Plain-language summary
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)
Who can participate
Age range18 Years – 90 Years
SexALL
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Inclusion criteria
✓. Completed 30 months of the blinded study treatment in Study AG10-301 and the Study AG10-301 Month 30 visit including assessments and procedures.
✓. Have the ability to understand and sign a written informed consent form, which must be obtained prior to initiation of study procedures.
✓. Female participants of childbearing potential who engage in heterosexual intercourse must agree to use a highly effective method of contraception beginning with enrollment and continuing for 30 days after the last dose of acoramidis. Female participants using oral contraceptives must agree to use an additional birth control method. While not considered highly effective, a double-barrier method is acceptable. A male participant who is sexually active with a female of childbearing potential and has not had a vasectomy must agree to use a double-barrier method of birth control.
Exclusion criteria
✕. Acute myocardial infarction, acute coronary syndrome or coronary revascularization within 90 days prior to Day 1 stroke or transient ischemic attack (TIA) within 90 days prior to Day 1.
✕. Has hemodynamic instability, that in the judgment of the Investigator, would pose too great a risk for participation in the study.
✕. Has had a heart and/or liver transplant or is on the heart transplantation list within the year prior to Day 1
✕. Has had implantation of a cardiac mechanical assist device (CMAD) or is scheduled for implantation of a CMAD
✕. Has confirmed diagnosis of light-chain (AL) amyloidosis at any time during Study AG10-301.
✕. Has estimated glomerular filtration rate (eGFR) by modification of diet for renal disease (MDRD) formula \< 15 mL/min/1.73 m2 at Month 27 of Study AG10-301 or at any subsequent central lab value prior to Day 1.
What they're measuring
1
Incidence of treatment-emergent Adverse Events [Safety and Tolerability]