WithdrawnPhase 3

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

Stopped: Study was discontinued for non-safety reasons and the rapidly evolving treatment landscape for AL amyloidosis.

0Started 2026-06

Plain-language 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.

Who can participate

Age range

18 Years – 70 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. 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 criteria

. 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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Proportion of bleeding events responsive to Coagdex® therapy at 72 hours after initiation of treatment in the On-Demand Treatment Cohort

Timeframe: at 72 hours

Proportion of bleeding events responsive to Coagdex® therapy at 72 hours after initiation of treatment in the Surgery/Invasive Procedures Cohort

Timeframe: at 72 hours

Trial details

NCT IDNCT06963216

SponsorKedrion S.p.A.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-06-10

View on ClinicalTrials.gov More Acquired Factor X Deficiency trials

Who can participate

Age range

18 Years – 70 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. 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 criteria

. 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.

What they're measuring

Proportion of bleeding events responsive to Coagdex® therapy at 72 hours after initiation of treatment in the On-Demand Treatment Cohort

Timeframe: at 72 hours

Proportion of bleeding events responsive to Coagdex® therapy at 72 hours after initiation of treatment in the Surgery/Invasive Procedures Cohort

Timeframe: at 72 hours