Clinical Trials in Spain / NCT07213583
Active, not recruiting
Phase 2
Study of Re-Treatment With ALXN2220 in Patients With ATTR-CM
NCT07213583 · tracked via the Priya Life Science Spain tracker
Condition(s) studied
Amyloid Transthyretin Cardiomyopathy
Investigational drug(s) / intervention(s)
ALXN2220: Participants will receive ALXN2220 via IV infusion.
Study summary
This is a Phase 2, single-arm, multicenter study to evaluate the pharmacodynamics and safety of re-treatment with ALXN2220 in previous participants of Study NI006-101.
Eligibility
Inclusion Criteria:
* Must have received at least one dose of ALXN2220 in Study NI006-101
Exclusion Criteria:
* Suspected or known intolerance/allergy to proteins or any components of the study drug
* Treatment or study discontinuation in Study NI006-101 due to a treatment-related adverse event that was serious, severe or life-threatening (on Common terminology criteria for adverse events (CTCAE) scale)
* Any new or uncontrolled condition after completion of Study NI006-101 that could make the participant unsuitable for participation in this study
Primary outcome measure(s)
- Change from Baseline to Week 48 in ECV measured by cMRI — Baseline, Week 48
- Change from Baseline to Week 48 in Heart Retention/Whole Body Retention measured by scintigraphy — Baseline, Week 48
Trial sites (6)
| Facility | City | Region | Status |
|---|---|---|---|
| Hôpital Henri Mondor | Créteil | France | |
| CHU de Rennes - Hôpital Pontchaillou | Rennes | France | |
| CHU Toulouse - Hôpital Rangueil | Toulouse | France | |
| Universitätsklinikum Heidelberg | Heidelberg | Germany | |
| University Medical Center Groningen | Groningen | Netherlands | |
| Hospital Universitario Puerta de Hierro Majadahonda | Majadahonda | Spain |
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 NCT07213583 on ClinicalTrials.gov ↗ ← All trials in Spain