AuthorisedTherapeutic confirmatory (Phase III)Interventional

Efanesoctocog alfa treatment in patients with synovitis in congenital hemophilia A: multicenter, randomized, open-label, phase 3 clinical trial

This study is investigating a new medicine called Altuvoct for adult men with severe haemophilia A. Specifically, it's for those who experience painful joint swelling, known as synovitis, which is common in haemophilia. The main goal is to see if Altuvoct can reduce or get rid of this swelling in affected joints over 12 months, using special ultrasound scans. Researchers will also look at how well the medicine prevents bleeding, how long it stays in the body, and any side effects. This research is important because it could lead to better treatments for managing joint health in people with haemophilia A.

At a glance

Status

Authorised

Phase

Therapeutic confirmatory (Phase III)

Sponsor

GWT-Tud GmbH

Enrolment target

Start

08 Jun 2026

Congenital hemophilia A (HA), Synovitis

What is this study about?

This study is about a new treatment called Altuvoct for adult men who have congenital haemophilia A. Congenital haemophilia A is a condition where your blood doesn't clot properly due to a lack of a specific protein. This can lead to bleeding inside joints, which over time can cause problems like synovitis – painful inflammation and swelling in the joint lining.

The main aim of this study is to find out if Altuvoct can help reduce or get rid of this joint swelling. Researchers will use special ultrasound scans to carefully check the joints over 12 months. This type of scan is very good at showing changes in the joint lining. They will compare how the joints look before and after treatment to see if the swelling has improved.

Besides looking at joint swelling, the study will also check other important things. This includes how effectively Altuvoct prevents bleeding episodes, how long the medicine stays active in the body, and if there are any side effects. Understanding these aspects helps doctors know if Altuvoct is a safe and effective treatment to improve joint health and overall well-being for men with haemophilia A.

Key takeaways

This study evaluates a new drug, Altuvoct, for joint swelling in men with haemophilia A.
It aims to see if Altuvoct can reduce swelling and improve joint health.
The study also monitors how well the medicine prevents bleeds and its safety.
Ultrasound scans are used to carefully measure changes in joint swelling.
Participation involves regular clinic visits for assessments and medication.

Who may be eligible?

This study is looking for men aged 18 or older who have congenital haemophilia A. You would need to have specific joint swelling (synovitis) problems that the researchers want to study.

There might be other health conditions or treatments that would mean you couldn't take part. The study team will review your medical history carefully to make sure it's safe for you.

Remember, your doctor will be able to tell you if this study might be a good fit for you based on your individual health needs.

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 an adult man (18 years or older)?
Do you have a diagnosis of congenital haemophilia A?
Do you have problems with swelling or inflammation in your joints (synovitis)?
Are you able to attend regular clinic appointments for the study?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you would receive the study medicine, Altuvoct, which is given as an injection. The specific dose you receive would be chosen by the study doctors from a range of available strengths. Over the course of the study, you would have several visits to the clinic for assessments. These would include detailed ultrasound scans of your joints to check for improvements in swelling, and blood tests to monitor how the medicine is working and for safety. You would also report any bleeding episodes and side effects. The study is planned to last for 12 months, with follow-up appointments after that time.

Potential risks and benefits

Taking part in a clinical trial may offer potential benefits, such as gaining access to a new treatment before it's widely available, which might help your joint swelling. However, there are also potential risks, as with any new medicine. You might experience side effects from the study medication, which the research team will monitor closely. Your health and safety are the top priority. You are free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (2)

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

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Unverified
Austria
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Unverified
Germany

Common questions

What is synovitis?

Synovitis is when the lining of your joints (called the synovium) becomes inflamed and swollen. It can be painful and is common in people with haemophilia due to repeated bleeding into the joints.

What is Altuvoct?

Altuvoct is the name of the new medicine being tested in this study. It's designed to help replace the missing clotting factor in people with haemophilia A.

How long will the study last?

The main part of the study where you receive the treatment and have assessments will last for 12 months. There might be some follow-up after that.

Will I know if I'm getting the active medicine?

This is an 'open-label' study, which means both you and your study doctor will know that you are receiving the Altuvoct medicine.

What kind of tests will I have?

You'll have special ultrasound scans of your joints to check for swelling, as well as blood tests to see how the medicine is working and to monitor your health.