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An 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 (AG10301)
EU CTIS ID: 2024-515092-36-00
What this study is testing
To assess safety and tolerability of acoramidis in participants with symptomatic transthyretin amyloid cardiomyopathy (ATTR-CM)
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 1. Completed 30 months of the blinded study treatment in Study AG10301 and the Study AG10-301 Month 30 visit including assessments and procedures.
- 2. Have the ability to understand and sign a written informed consent form, which must be obtained prior to initiation of study procedures.
- 3. Women of childbearing potential (WOCBP) 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 women of childbearing potential and has not had a vasectomy must agree to use a double-barrier method of birth control.
You likely can't join if
- 1. Has hemodynamic instability, that in the judgment of the Investigator, would pose too great a risk for participation in the study.
- 10. Participation in another interventional clinical trial (with the exception of Study AG10-301) within 30 days prior to dosing. Participation in observational and/or registry studies should be discussed with the Medical Monitor.
- 11. Has any condition that in the opinion of the Investigator or Medical Monitor would preclude compliance with the study protocol such as a history of substance abuse, alcoholism, or a psychiatric condition.
- 2. Has had a heart and/or liver transplant within the year prior to Day 1.
- 3. Has had implantation of a cardiac mechanical assist device (CMAD).
- 4. Has confirmed diagnosis of light-chain (AL) amyloidosis at any time during Study AG10-301.
See the full eligibility criteria
- 1. Completed 30 months of the blinded study treatment in Study AG10301 and the Study AG10-301 Month 30 visit including assessments and procedures.
- 2. Have the ability to understand and sign a written informed consent form, which must be obtained prior to initiation of study procedures.
- 3. Women of childbearing potential (WOCBP) 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 women of childbearing potential and has not had a vasectomy must agree to use a double-barrier method of birth control.
- 1. Has hemodynamic instability, that in the judgment of the Investigator, would pose too great a risk for participation in the study.
- 10. Participation in another interventional clinical trial (with the exception of Study AG10-301) within 30 days prior to dosing. Participation in observational and/or registry studies should be discussed with the Medical Monitor.
- 11. Has any condition that in the opinion of the Investigator or Medical Monitor would preclude compliance with the study protocol such as a history of substance abuse, alcoholism, or a psychiatric condition.
- 2. Has had a heart and/or liver transplant within the year prior to Day 1.
- 3. Has had implantation of a cardiac mechanical assist device (CMAD).
- 4. Has confirmed diagnosis of light-chain (AL) amyloidosis at any time during Study AG10-301.
- 5. Is on dialysis or has a degree of renal impairment that in the opinion of the Investigator might jeopardize the participant's safety, increase their risk from participation, or interfere with the study.
- 6. Known hypersensitivity to acoramidis, its metabolites, or formulation excipients.
- 7. At the end of Study AG10-301 or at Day 1 of Study AG10-304 (or any time during the study), participant is on prohibited medication.
- 8. Females who are pregnant or breastfeeding. A negative urine pregnancy test at the Day 1 visit and at each study visit are required for WOCBP.
- 9. In the judgment of the Investigator or Medical Monitor, has any clinically important ongoing medical condition or laboratory abnormality or condition that might jeopardize the participant's safety, increase their risk from participation, or interfere with the study.
The study team makes the final eligibility decision.
Where it's taking place
- Brazil
- Korea, Democratic People's Republic of
- New Zealand
- Australia
- United Kingdom
- Canada
- Israel
- United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Brazil; Korea, Democratic People's Republic of; New Zealand; Australia; United Kingdom; Canada and 2 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.