Clinical Trial

A Study Investigating Coagadex in the Treatment AFXD Associated With AL Amyloidosis

Withdrawn Phase 3
View on ClinicalTrials.gov →
Why the trial stopped
Study was discontinued for non-safety reasons and the rapidly evolving treatment landscape for AL amyloidosis.
Summary
The purpose of this study is to evaluate the efficacy and safety of Coagadex in treating active bleeds and to manage peri-operative bleeding in participants with acquired factor X deficiency associated with AL amyloidosis.
Protocol Amendment History 5 changes
critical Trial status changed: Recruiting → Withdrawn 2026-06-30
notable Enrollment reduced: 15 -> 0 participants 2026-06-30
notable Trial sites reduced: 3 -> 0 locations 2026-06-30
notable Primary completion moved earlier: 2027-06 -> 2026-06-10 2026-06-30
minor Completion moved earlier: 2027-09 -> 2026-06-10 2026-06-30
Trial Details
NCT Number NCT06963216
Lead Sponsor Kedrion S.p.A.
Conditions Acquired Factor X Deficiency
Start Date 2026-06
Primary Completion 2026-06-10 (estimated)
Study Completion 2026-06-10 (estimated)
Updated on ClinicalTrials.gov 2026-06-29