Clinical Trials in Italy / NCT04988386
Active, not recruiting
Phase 3
Open-Label Safety Study of Acoramidis (AG10) in Symptomatic ATTR Participants
NCT04988386 · tracked via the Priya Life Science Italy tracker
Condition(s) studied
Amyloid Cardiomyopathy, Transthyretin-Related
Investigational drug(s) / intervention(s)
Acoramidis (AG10): Acoramidis (AG10) twice daily
Study 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)
Eligibility
Inclusion Criteria:
1. Completed 30 months of the blinded study treatment in Study AG10-301 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. 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:
1. 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.
2. Has hemodynamic instability, that in the judgment of the Investigator, would pose too great a risk for participation in the study.
3. Has had a heart and/or liver transplant or is on the heart transplantation list within the year prior to Day 1
4. Has had implantation of a cardiac mechanical assist device (CMAD) or is scheduled for implantation of a CMAD
5. Has confirmed diagnosis of light-chain (AL) amyloidosis at any time during Study AG10-301.
6. 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.
7. Known hypersensitivity to acoramidis, its metabolites, or formulation excipients.
8. 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.
9. Females who are pregnant or breastfeeding. A negative urine pregnancy test at the Day 1 visit and at each study visit are required for female participants of childbearing potential.
10. 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.
11. 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.
12. 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.
Primary outcome measure(s)
- Incidence of treatment-emergent Adverse Events [Safety and Tolerability] — 60 months
Incidence of each treatment-emergent adverse events measured over 60 Months or study completion
Trial sites (72)
| Facility | City | Region | Status |
|---|---|---|---|
| Cedars-Sinai Medical Center | Los Angeles | California | |
| University of Colorado Hospital - Anschutz Medical Campus | Aurora | Colorado | |
| Northwestern University | Chicago | Illinois | |
| University of Chicago Medical Center | Chicago | Illinois | |
| NorthShore University Health System | Evanston | Illinois | |
| MedStar Medical Group Cardiology at Franklin Square | Baltimore | Maryland | |
| Boston University Medical Center General Clinical Research Unit | Boston | Massachusetts | |
| Mayo Clinic - Rochester | Rochester | Minnesota | |
| Saint Luke's Hospital of Kansas City | Kansas City | Missouri | |
| Washington University | St Louis | Missouri | |
| New York University Langone Health | New York | New York | |
| Columbia University Irving Medical Center | New York | New York | |
| Laurelton Heart Specialists | Rosedale | New York | |
| Montefiore Medical Center at Hutchinson | The Bronx | New York | |
| Duke University Health System - Duke Clinic | Durham | North Carolina | |
| Cleveland Clinic Main Campus | Cleveland | Ohio | |
| Oregon Health & Science University | Portland | Oregon | |
| Penn Presbyterian Medical Center | Philadelphia | Pennsylvania | |
| University of Pittsburgh Medical Center (UPMC) | Pittsburgh | Pennsylvania | |
| Medical University of South Carolina | Charleston | South Carolina | |
| University of Texas Southwestern Medical Center | Dallas | Texas | |
| University of Utah | Salt Lake City | Utah | |
| Virginia Commonwealth University Health System | Richmond | Virginia | |
| Roanoke Heart Institute | Roanoke | Virginia | |
| University of Washington School of Medicine | Seattle | Washington | |
| Providence Sacred Heart Children's Hospital | Spokane | Washington | |
| Saint Vincent's Hospital Sydney | Darlinghurst | New South Wales | |
| Princess Alexandra Hospital | Woolloongabba | Queensland | |
| Royal Adelaide Hospital | Adelaide | South Australia | |
| Royal Hobart Hospital | Hobart | Tasmania | |
| Box Hill Hospital | Box Hill | Victoria | |
| Fiona Stanley Hospital | Murdoch | Western Australia | |
| Ziekenhuis Oost-Limburg | Genk | Limburg | |
| Algemeen Ziekenhuis Sint-Jan Brugge-Oostende - Campus Sint-Jan | Bruges | West Vlaanderen | |
| Instituto de Cardiologia do Rio Grande do Sul | Porto Alegre | Rio Grande do Sul | |
| Centro Avançado de Pesquisa e Estudos para o Diagnóstico CAPED | Ribeirão Preto | São Paulo | |
| Instituto do Coração de São Paulo | São Paulo | São Paulo | |
| Vancouver General Hospital | Vancouver | British Columbia | |
| Saint Boniface Hospital | Winnipeg | Manitoba | |
| Queen Elizabeth II Health Sciences Centre - Halifax Infirmary | Halifax | Nova Scotia |
+ 32 more sites — see the full list on the official registry below.
More Eidos Therapeutics, a BridgeBio company trials in Italy
Official registry record
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.
View NCT04988386 on ClinicalTrials.gov ↗ ← All trials in Italy