RecruitingPHASE3INTERVENTIONAL

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

This study is looking into a treatment called Coagadex for a rare bleeding disorder known as acquired Factor X deficiency (aFXD) that can occur with AL amyloidosis. People with aFXD have blood that doesn't clot properly, increasing their risk of bleeding. This trial, in its final testing stage (Phase 3), will assess how well Coagadex works to stop active bleeding episodes and prevent heavy bleeding during and after surgery. Coagadex is a concentrated form of a natural clotting protein (Factor X) that aims to correct the clotting problem. The study will also carefully check if Coagadex is safe to use. This research is important for improving treatment options for this uncommon condition.

At a glance

Status

Recruiting

Phase

PHASE3

Sponsor

Kedrion S.p.A.

Enrolment target

Start

01 Jun 2026

Estimated completion

01 Sep 2027

Acquired Factor X Deficiency

What is this study about?

This study is investigating a new treatment named Coagadex for a specific type of bleeding disorder called acquired Factor X deficiency (aFXD). This condition means your blood doesn't clot as it should because you don't have enough of a protein called Factor X. In this particular study, aFXD is linked to another illness called AL amyloidosis. AL amyloidosis can cause unusual protein clusters to build up in your body, and these clusters can interfere with Factor X, leading to bleeding problems.

Coagadex is a medication designed to replace the missing or reduced Factor X in your blood. It works by providing a concentrated amount of this important clotting protein, helping your blood clot more effectively. The main goals of this study are to find out if Coagadex can successfully stop bleeding episodes and if it can help prevent excessive bleeding when someone with aFXD needs an operation. Researchers will also be closely monitoring participants to make sure the treatment is safe.

Acquired Factor X deficiency is very rare, affecting fewer than 1 in a million people. It can range from moderate to severe, depending on how much Factor X is in your blood. Because AL amyloidosis is the most common reason for this type of Factor X deficiency, finding effective treatments is crucial for improving the lives of those affected by this challenging condition.

Key takeaways

This study is for a rare bleeding disorder called acquired Factor X deficiency (aFXD) linked to AL amyloidosis.
It's testing a new medication, Coagadex, to see if it can stop bleeding and help during surgery.
Coagadex is a concentrated form of the clotting protein Factor X.
This is a Phase 3 study, meaning it's a key step in testing the treatment.
Potential benefits include better bleeding control, but like all medicines, there could be side effects.

Who may be eligible?

To be able to take part in this study, you must be between 18 and 70 years old. You need to have been diagnosed with acquired Factor X deficiency (aFXD) linked to AL amyloidosis, and your Factor X levels must be 50% or less of the normal amount.

There are also some reasons why you might not be able to join the study. For instance, if you are pregnant or breastfeeding, or if you have another bleeding disorder that isn't aFXD, you wouldn't be eligible. If you have uncontrolled high blood pressure, certain heart conditions, or have had a significant blood clot recently, this might also prevent you from participating. Additionally, if you've recently taken other Factor X medications or are taking certain blood thinners, you may not be able to join. The study team will assess all these factors carefully.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you between 18 and 70 years old?
Have you been diagnosed with acquired Factor X deficiency (aFXD) linked to AL amyloidosis?
Are your Factor X levels 50% or less of the normal amount?
Are you not pregnant or breastfeeding?
Have you not had a significant blood clot in the last 6 months?
Are you not taking certain blood-thinning medications?

Answer every question to see your result.

What does participation involve?

Taking part in this study would involve a series of visits to the clinic. During these visits, you would receive the study medication, Coagadex, and the research team would closely monitor your health. This includes checking for any bleeding episodes and how they respond to treatment, as well as managing any bleeding that might occur around the time of surgery. You would also have blood tests and other assessments to track your Factor X levels and overall health. The exact number of visits and the total duration of your participation would depend on your individual treatment needs and how long you are on the study medication, but the team will explain this in detail.

Potential risks and benefits

Participating in this study might offer potential benefits, such as receiving a new treatment that could help manage your bleeding episodes more effectively and improve your ability to undergo necessary surgeries. However, like all medications, Coagadex may have side effects, and the research team will carefully monitor you for any potential risks or unwanted reactions. You have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (3)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

Mayo Clinic Arizona
Verified postcode
Phoenix, United States· Recruiting
Mayo Clinic Rochester
Verified postcode
Rochester, United States· Recruiting
Cancer Clinical Trials Unit
Verified postcode
London, United Kingdom· Recruiting

Common questions

What is Factor X?

Factor X is a natural protein in your blood that helps it clot and stop bleeding. If you don't have enough of it, you can have bleeding problems.

What is AL amyloidosis?

AL amyloidosis is a condition where abnormal protein clusters build up in organs and tissues, which can sometimes interfere with normal body functions, including blood clotting.

Is Coagadex a new treatment?

Yes, Coagadex is considered an investigational treatment in this study, meaning it's still being evaluated to see how well it works and if it's safe for people with acquired Factor X deficiency linked to AL amyloidosis.

What does 'Phase 3' mean for a study?

Phase 3 is one of the final stages of clinical research. It means the treatment has already shown some promise and is now being tested in a larger group of people to confirm its effectiveness and safety before it can be widely used.

Can I still take part if I'm on other medicines?

It depends on the medicine. Certain medications, especially some blood thinners or other Factor X products, might mean you can't join. The study team will review all your medications carefully.

How to find out more

Nicola Rovai

n.rovai@kedrion.com +39 335 6524750 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.