Clinical Trials in South Korea / NCT07789483
Starting soon
Phase 3
An Open-Label Study to Evaluate the Long-Term Safety and Efficacy of ALXN2220 in Adults With Transthyretin Amyloid Cardiomyopathy
NCT07789483 · tracked via the Priya Life Science South Korea tracker
Condition(s) studied
Transthyretin Amyloid Cardiomyopathy (ATTR-CM)
Study summary
The purpose of Study ALXN2220-ATTRCM-302 is to evaluate the long-term safety, tolerability and efficacy of ALXN2220 in adult participants with ATTR-CM treated with ALXN2220 in addition to SoC who have completed Study ALXN2220-ATTRCM-301.
Eligibility
* Inclusion Criteria
* Type of Participant: Participants who have completed the Blinded Treatment Period (including the PC visit) of Study 301.
* Sex and Contraceptive/Barrier Requirements: Male and/or female (according to their reproductive organs and functions assigned by chromosomal complement).
* Informed Consent: Participant, or legally authorized representative where relevant and allowed by law, is willing and able to comply with all study requirements and to provide signed informed consent.
* Exclusion Criteria
* Participants who permanently discontinued study intervention in Study 301
* Participants who withdrew full consent during Study 301.
* Medical Conditions: Suspected or known intolerance/allergy to proteins or any components of ALXN2220. Has had a heart transplant or permanent CMAD implantation. Has any new or worsening of existing medical or psychological condition or risk factor that in the opinion of the Investigator or Sponsor might jeopardize participant's safety or compliance with the protocol, or pose any additional risk for the participant, or confound the assessment of the participant or outcome of the study.
* Prior/Concurrent/Future Clinical Study Experience: Current or future participation in another investigational clinical study or intake of investigational drug within 30 calendar days or 5 half-lives of the study intervention, whichever is longer, before signing the ICF, except for study intervention used in Study 301.
Primary outcome measure(s)
- Percentage of participants with TEAEs — Up to 24 months
To evaluate the long-term safety and tolerability of ALXN2220 in participants with ATTR-CM
Trial sites (195)
| Facility | City | Region | Status |
|---|---|---|---|
| Research Site | Irvine | California | |
| Research Site | La Jolla | California | |
| Research Site | Palo Alto | California | |
| Research Site | San Francisco | California | |
| Research Site | Aurora | Colorado | |
| Research Site | Washington D.C. | District of Columbia | |
| Research Site | Jacksonville | Florida | |
| Research Site | Weston | Florida | |
| Research Site | Atlanta | Georgia | |
| Research Site | Atlanta | Georgia | |
| Research Site | Indianapolis | Indiana | |
| Research Site | Boston | Massachusetts | |
| Research Site | Boston | Massachusetts | |
| Research Site | Kansas City | Missouri | |
| Research Site | St Louis | Missouri | |
| Research Site | New York | New York | |
| Research Site | New York | New York | |
| Research Site | Stony Brook | New York | |
| Research Site | Chapel Hill | North Carolina | |
| Research Site | Durham | North Carolina | |
| Research Site | Cleveland | Ohio | |
| Research Site | Columbus | Ohio | |
| Research Site | Portland | Oregon | |
| Research Site | Danville | Pennsylvania | |
| Research Site | Philadelphia | Pennsylvania | |
| Research Site | Charleston | South Carolina | |
| Research Site | Greenville | South Carolina | |
| Research Site | Memphis | Tennessee | |
| Research Site | Fort Worth | Texas | |
| Research Site | Houston | Texas | |
| Research Site | Salt Lake City | Utah | |
| Research Site | Falls Church | Virginia | |
| Research Site | Richmond | Virginia | |
| Research Site | Seattle | Washington | |
| Research Site | Madison | Wisconsin | |
| Research Site | Buenos Aires | Buenos Aires | |
| Research Site | CABA | Buenos Aires | |
| Research Site | Ciudad de Buenos Aires | Buenos Aires F.D. | |
| Research Site | Córdoba | Córdoba Province | |
| Research Site | Ciudad de Buenos Aires | Argentina |
+ 155 more sites — see the full list on the official registry below.
More Alexion Pharmaceuticals, Inc. trials in South Korea
Safety and Efficacy of ALXN1720 in Adults With Generalized Myasthenia Gravis
Active, not recruiting
Study of ALXN2220 Versus Placebo in Adults With ATTR-CM
Active, not recruiting
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 NCT07789483 on ClinicalTrials.gov ↗ ← All trials in South Korea