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RecruitingPHASE3INTERVENTIONAL

Open-Label Extension Study of Marstacimab in Hemophilia Participants With or Without Inhibitors

This study, called B7841007, is continuing to look at a medicine called marstacimab. It's for people with haemophilia A or B who have already taken part in previous studies of this medicine (B7841005 and B7841008). The main goal is to check how safe marstacimab is over a long time and if it continues to help prevent bleeding episodes effectively. It's an 'open-label' study, meaning everyone knows they are getting the active medicine. This research helps us understand more about using marstacimab as a regular treatment to protect people with haemophilia in the long run. Participants will receive marstacimab using either a pre-filled pen or syringe.

At a glance

Status
Recruiting
Phase
PHASE3
Sponsor
Pfizer
Enrolment target
245
Start
17 Nov 2021
Estimated completion
31 Jul 2030

What is this study about?

This study is important because it's looking at a new medicine called marstacimab for people with haemophilia A or B. Haemophilia is a condition where your blood doesn't clot properly, leading to longer bleeding. Marstacimab is being tested to see if it can help prevent these bleeding episodes.

This particular study is a 'long-term' study, which means it follows people who have already taken part in earlier studies of marstacimab. The main aim is to carefully check if the medicine is safe and if it continues to work well over a longer period. It's especially looking at how well it prevents bleeds and what side effects might happen.

The study includes children from 1 year old up to adults aged 74. Participants will receive marstacimab as an injection, using either a pre-filled pen or a pre-filled syringe, depending on what works best for them and what's available. The information gathered from this study will help us understand more about using marstacimab every day for people living with haemophilia.

Key takeaways

  • This study is looking at the long-term safety and effectiveness of marstacimab for haemophilia A or B.
  • It's an extension study for people who previously participated in earlier marstacimab trials.
  • Participants will receive marstacimab injections using a special pen or syringe.
  • The study includes males aged 1 to 74 and involves regular check-ups.
  • It aims to gather more information about marstacimab as a long-term treatment option.

Who may be eligible?

To join this study, you must have already taken part in one of the earlier marstacimab studies (B7841005 or B7841008) and completed it without having to stop early. You also need to be able to attend all the scheduled appointments and follow the study rules. Your body weight must meet a certain minimum, which would have been checked in the earlier studies.

There are several reasons why someone might not be able to join. For example, if you have a history of certain heart or blood clot problems, or kidney issues. You also can't join if you have unstable liver problems or if you have HIV and your condition is getting worse. If you're planning to have surgery during the study or are taking certain other medications (like strong medicines that affect your immune system or other haemophilia treatments like FVIII or FIX), you unfortunately won't be able to take part. Also, if you're involved in another study testing a new medicine or vaccine, you can't join this one.

This study is open to males aged between 1 and 74 years old. The researchers want to make sure everyone in the study is as safe as possible, which is why these checks are in place.

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.

  1. Have I completed a previous marstacimab study without stopping early?
  2. Am I generally healthy, apart from haemophilia, and able to attend all appointments?
  3. Do I have any serious heart, kidney, or liver problems?
  4. Am I currently taking any other investigational drugs or certain other haemophilia treatments?
  5. Am I a male aged between 1 and 74 years old?
Answer every question to see your result.

What does participation involve?

If you take part in this study, you'll continue to receive your marstacimab medicine as an injection, using either a special pen or a syringe. You'll have regular visits to the clinic so the study team can check on your health, assess how well the medicine is working, and look for any side effects. You'll also have blood tests and other assessments during these visits. The study involves long-term follow-up to see how you respond to the treatment over time. The team will guide you on how to give yourself the injections and what to expect during your appointments. The total duration of your participation will depend on how long the study continues, as it's an extension study.

Potential risks and benefits

Taking part in this study could offer potential benefits, such as continuing to receive marstacimab, which aims to prevent bleeding episodes if it's effective for you. However, as with any medicine, there are potential risks, including side effects from marstacimab or discomfort from injections and blood tests. You will be closely monitored for any health changes. Remember, joining a study is always your choice, and you have the right to withdraw at any time without giving a reason, and this will not affect your usual medical care.

Locations (75)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.
  • University of Iowa
    Verified postcode
    Iowa City, United States· Active not recruiting
  • Northwell Health HTC
    Verified postcode
    New Hyde Park, United States· Recruiting
  • The Feinstein Institutes for Medical Research
    Verified postcode
    Philadelphia, United States· Recruiting
  • Washington Institute for Coagulation d/b/a WACBD
    Verified postcode
    Seattle, United States· Recruiting
  • Arbesu Hematología
    Verified postcode
    Mendoza, Argentina· Recruiting
  • Royal Children's Hospital
    Verified postcode
    Melbourne, Australia· Recruiting
  • HEMOES
    Verified postcode
    Vitória, Brazil· Recruiting
  • Stollery Children's Hospital
    Verified postcode
    Edmonton, Canada· Recruiting
  • Hamilton Health Sciences - McMaster University Medical Centre
    Verified postcode
    Hamilton, Canada· Recruiting
  • Hamilton Health Sciences - McMaster University Medical Centre
    Verified postcode
    Hamilton, Canada· Recruiting
  • Nanfang Hospital, Southern Medical University
    Verified postcode
    Guangzhou, China· Recruiting
  • The Affiliated Hospital of Guizhou Medical University
    Verified postcode
    Guiyang, China· Recruiting

Common questions

What is marstacimab?

Marstacimab is a new medicine being tested to help prevent bleeding in people with haemophilia A or B.

Who can join this study?

This study is for males aged 1 to 74 who have already completed a previous marstacimab study and did not drop out early.

How will I take the medicine?

You will take marstacimab as an injection under the skin, using either a special pre-filled pen or a pre-filled syringe.

What kind of appointments will I have?

You'll have regular clinic visits for health checks, blood tests, and to make sure the medicine is working safely for you.

Can I stop being in the study if I want to?

Yes, you can choose to leave the study at any time, for any reason, and it won't affect your future medical care.

How to find out more

Pfizer CT.gov Call Center

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

Interested in taking part?

Register your interest

Share your details and the research team for "Open-Label Extension Study of Marstacimab in Hemophilia Part…" will contact you if you may be eligible. Always speak to your GP before agreeing to take part.

Discussion

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