Clinical Trials in Poland / NCT05667493
Enrolling by invitation
Phase 3
An Extension Study to Assess Long-Term Safety of Eplontersen in Adults With Transthyretin-Mediated Amyloid Cardiomyopathy (ATTR-CM)
NCT05667493 · tracked via the Priya Life Science Poland tracker
Condition(s) studied
Transthyretin-Mediated Amyloid Cardiomyopathy (ATTR CM)
Investigational drug(s) / intervention(s)
Eplontersen: Eplontersen will be administered by SC injection.
Study summary
The purpose of this study is to evaluate the safety and tolerability of extended dosing with eplontersen in participants with ATTR-CM.
Eligibility
Inclusion Criteria:
1. Satisfactory completion of Treatment Period and the End of Treatment Visit of the Index Study (ION-682884-CS2) OR diagnosis of ATTR-CM and satisfactory participation on ISIS 420915- CS101 study as judged by the Investigator and Sponsor.
2. Investigator is willing to treat the participant with open-label eplontersen.
3. Willingness to adhere to vitamin A supplementation per protocol.
Exclusion Criteria:
1. Permanently discontinued study drug administration while participating in the Index Study (ION 682884-CS2) or IST (ISIS 420915-CS101 Study).
2. Have any new condition or worsening of an existing condition that in the opinion of the Investigator or Sponsor would make the participant unsuitable for enrolment, or which could interfere with the participant participating in or completing the study, including the need for treatment with medications disallowed in the Index Study.
Primary outcome measure(s)
- Number of Participants With Adverse Events (AE) and Serious Adverse Events (SAE) — Baseline up to 36 months
- Change From Baseline in Platelet Count — Baseline up to 36 months
- Change From Baseline in Estimated Glomerular Filtration Rate (eGFR) — Baseline up to 36 months
- Change From Baseline in Urine Protein Creatinine Ratio (UPCR) — Baseline up to 36 months
Trial sites (134)
| Facility | City | Region | Status |
|---|---|---|---|
| Mayo Clinic | Scottsdale | Arizona | |
| Cedars-Sinai Medical Center | Beverly Hills | California | |
| Altman Clinical and Translational Research Institute - Center for Clinical Research | La Jolla | California | |
| University Of California San Francisco Urology Practice | San Francisco | California | |
| Stanford University (Leland Stanford Junior University) | Stanford | California | |
| University of Colorado Hospital - Anschutz Medical Campus | Aurora | Colorado | |
| MedStar Washington Hospital Center | Washington D.C. | District of Columbia | |
| The George Washington Medical Faculty Associates - Foggy Bottom North Pavilion | Washington D.C. | District of Columbia | |
| Cleveland Clinic Florida | Weston | Florida | |
| Piedmont Heart of Fayetteville | Atlanta | Georgia | |
| Emory Heart and Vascular Center - Emory Clifton Campus | Atlanta | Georgia | |
| Piedmont Atlanta Hospital | Fayetteville | Georgia | |
| Northwestern University | Chicago | Illinois | |
| Loyola University Medical Center | Maywood | Illinois | |
| Indiana University Health University Hospital | Indianapolis | Indiana | |
| University of Kansas Medical Center (KUMC) | Kansas City | Kansas | |
| University of Kansas Medical Center | Kansas City | Kansas | |
| University of Maryland Medical Center | Baltimore | Maryland | |
| Massachusetts General Hospital | Boston | Massachusetts | |
| Brigham and Women's Hospital | Boston | Massachusetts | |
| Boston University School of Medicine | Boston | Massachusetts | |
| Henry Ford Health System | Detroit | Michigan | |
| Allina Health Minneapolis Heart Institute - Abbott Northwestern's Heart Hospital | Minneapolis | Minnesota | |
| Mayo Clinic | Rochester | Minnesota | |
| Saint Luke's Hospital of Kansas City | Kansas City | Missouri | |
| Barnes-Jewish Hospital | St Louis | Missouri | |
| New York University Langone Cardiology Associates | New York | New York | |
| Weill Cornell Medicine Cardiology | New York | New York | |
| Columbia University Irving Medical Center | New York | New York | |
| University of North Carolina at Chapel Hill | Chapel Hill | North Carolina | |
| Duke University Medical Center | Durham | North Carolina | |
| Carl and Edyth Lindner Research Center at The Christ Hospital | Cincinnati | Ohio | |
| University Hospitals Cleveland Medical Center | Cleveland | Ohio | |
| Cleveland Clinic Main Campus | Cleveland | Ohio | |
| The Ohio State University College of Medicine | Columbus | Ohio | |
| Oregon Health and Science University | Portland | Oregon | |
| Lancaster General Hospital | Lancaster | Pennsylvania | |
| Penn Presbyterian Medical Center | Philadelphia | Pennsylvania | |
| Medical University of South Carolina | Charleston | South Carolina | |
| Vanderbilt Heart and Vascular Institute | Nashville | Tennessee |
+ 94 more sites — see the full list on the official registry below.
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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 NCT05667493 on ClinicalTrials.gov ↗ ← All trials in Poland