Status:
NOT_YET_RECRUITING
A Study Investigating Coagadex in the Treatment AFXD Associated With AL Amyloidosis
Lead Sponsor:
Kedrion S.p.A.
Collaborating Sponsors:
Worldwide Clinical Trials
Conditions:
Acquired Factor X Deficiency
Eligibility:
All Genders
18-70 years
Phase:
PHASE3
Brief 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 associate...
Detailed Description
This study is designed to evaluate the efficacy and safety of Coagadex® in treating active bleeds and to manage peri-operative bleeding in participants with aFXD associated with AL amyloidosis. Coagad...
Eligibility Criteria
Inclusion
- Male or female participants ages 18-70 years old.
- Diagnosis of aFXD associated with AL amyloidosis with FX:C ≤ 50 IU/dL.
- Woman of Childbearing Potential (defined in Appendix 2) and men of reproductive potential who agree to use an effective contraception measure during the study.
Exclusion
- Female participants that are pregnant or lactating.
- Presence of FX inhibitors.
- Uncontrolled arterial hypertension.
- On anticoagulant therapy (not antiplatelets), unstable heart disease, clinically significant thrombotic event in the past 180 days or any other condition that the Investigator believes is likely to interfere with evaluation of the study drug or with satisfactory conduct of the trial.
- Any factor X containing product taken within 2 weeks of first Coagadex® administration.
- Participation in another interventional clinical study with an investigational drug, biologic, or device within 30 days prior to screening.
- Hemodynamically unstable due to any cause or even after blood transfusion, fluid resuscitation and pharmacologic or volume replacement pressor therapy.
- Prior history of bleeding disorder other than aFXD.
Key Trial Info
Start Date :
December 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2027
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT06963216
Start Date
December 1 2025
End Date
September 1 2027
Last Update
August 27 2025
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