Active not recruitingOBSERVATIONAL

Study to Learn More About the Safety of Drug Jivi Over a Long Period of Time in Previously Treated Patients With Hemophilia A (Bleeding Disorder Resulting From a Lack of FVIII) Who Are Receiving Jivi Regularly at Their Treating Doctors to Prevent Bleeding

This study is looking at the long-term safety of a medicine called Jivi for individuals who have haemophilia A. Haemophilia A is a bleeding disorder where the blood doesn't clot properly due to a lack of a specific protein, Factor VIII. Jivi is an approved treatment that helps replace this missing protein. It's designed to stay in the body longer than some other treatments, meaning people might need fewer injections. Researchers will observe patients who are already taking Jivi as part of their regular care to prevent bleeding. They will collect health information over at least four years during your routine check-ups with your doctor.

At a glance

Status

Active not recruiting

Sponsor

Bayer

Enrolment target

Start

14 May 2021

Estimated completion

30 Jun 2027

Hemophilia A

What is this study about?

Imagine your body has a special team of workers called clotting factors that help stop bleeding. If you have haemophilia A, you're missing an important worker called Factor VIII, which means your blood doesn't clot as well as it should. This can lead to longer bleeding after injuries or even bleeding inside your body.

Doctors often prescribe medicines to replace this missing Factor VIII. Jivi is one such medicine. It's special because it's been designed to stay in your body for a longer time, which means you might not need to take it as often as some other treatments. This study isn't testing a new medicine; it's about carefully watching people who are already using Jivi as part of their usual care.

The main goal of this study is to understand more about how safe Jivi is when used over many years. Researchers will simply collect information during your regular doctor's visits. They want to make sure that Jivi continues to be a good and safe treatment option for people with haemophilia A.

Key takeaways

This study is about the long-term safety of Jivi for people with haemophilia A.
It observes patients already taking Jivi, without giving new treatments.
Information is collected during your regular doctor's visits.
The study lasts for at least four years.
Your decision to take part is voluntary and won't affect your medical care.

Who may be eligible?

You might be able to take part in this study if you have haemophilia A and your doctor has already decided that Jivi is the right treatment for you to help prevent bleeding. It's important that your doctor made this decision before discussing this study with you, and not because of the study itself. You would also need to have a recent test showing that your body doesn't create certain antibodies (called inhibitors) against Factor VIII.

However, you wouldn't be able to join if you have any known reasons why Jivi wouldn't be suitable for you, or if you're already taking part in another study that involves specific treatments or procedures. Also, if there are any reasons that would make it difficult for you to understand or follow the study instructions, you wouldn't be able to participate.

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.

Do you have haemophilia A?
Has your doctor already prescribed Jivi for you to prevent bleeding?
Have you tested negative for Factor VIII inhibitors recently?
Are you able to understand and follow study instructions?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you won't be given any new treatments or asked to do anything different from your usual medical care. The study simply involves collecting information from your routine doctor's appointments. Every time you visit your doctor for your haemophilia A check-ups, the study team will gather details about your health and how you're responding to Jivi. This observation will happen for at least four years, covering your regular medical visits.

Potential risks and benefits

The main benefit of taking part is contributing to a better understanding of Jivi's long-term safety, which could help future patients. Since this is an observational study and you're already receiving Jivi, there are no new medical procedures or medicines involved, so the direct medical risks to you aren't increased by joining the study itself. However, all medicines, including Jivi, can have side effects, and you should always discuss any concerns with your doctor. Remember, you can decide to stop participating in the study at any time, for any reason, without it affecting your medical care.

Locations (6)

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

Many Locations
Unverified
Multiple Locations, Austria
Many Locations
Unverified
Multiple Locations, Germany
Many Locations
Unverified
Multiple Locations, Greece
Many Locations
Unverified
Multiple Locations, Italy
Many Locations
Unverified
Multiple Locations, Slovenia
Many Locations
Unverified
Multiple Locations, Spain

Common questions

What is haemophilia A?

Haemophilia A is a condition where your blood doesn't clot properly because you're missing a protein called Factor VIII. This can lead to bleeding problems.

What is Jivi?

Jivi is a medicine for haemophilia A that replaces the missing Factor VIII. It's designed to stay in your body longer, so you might need fewer injections.

Will I get new medicine in this study?

No, you won't get any new medicine. This study is just observing people who are already using Jivi as part of their regular care.

How long will I be in the study?

The study will observe your health for at least four years, gathering information during your routine doctor's visits.

Can I leave the study if I want to?

Yes, you can decide to stop taking part in the study at any time, and it won't affect your medical care.