Actively Recruiting
A Study Investigating Coagadex in the Treatment AFXD Associated With AL Amyloidosis
Led by Kedrion S.p.A. · Updated on 2026-05-11
15
Participants Needed
3
Research Sites
65 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Study Investigating Coagadex in the Treatment AFXD Associated With AL Amyloidosis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female participants ages 18-70 years old
- Diagnosis of acquired factor X deficiency associated with AL amyloidosis with factor X coagulant activity (FX:C) 50 IU/dL
- Women of childbearing potential and men of reproductive potential must agree to use effective contraception during the study
You will not qualify if you...
- Female participants who are pregnant or lactating
- Presence of factor X inhibitors
- Uncontrolled arterial hypertension
- Use of anticoagulant therapy (not antiplatelets), unstable heart disease, recent significant thrombotic events within 180 days, or other conditions interfering with study evaluation
- Use of any factor X containing product within 2 weeks prior to first Coagadex4 administration
- Participation in another interventional clinical study within 30 days prior to screening
- Hemodynamic instability despite blood transfusion, fluid resuscitation, or pharmacologic support
- Prior history of bleeding disorders other than acquired factor X deficiency
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 3 locations
1
Mayo Clinic Arizona
Phoenix, Arizona, United States, 85054
Actively Recruiting
2
Mayo Clinic Rochester
Rochester, Minnesota, United States, 55905
Actively Recruiting
3
Cancer Clinical Trials Unit
London, London, United Kingdom, NW1 2PG
Actively Recruiting
Research Team
N
Nicola Rovai
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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