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Contact Information:

Mrs Martina Jansen
+43 664 9227867
martina.jansen@octapharma.com


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Be Part of Research - Trial Details - Octapharma’s FVIII concentrates in previously untreated and minimally treated haemophilia A patients
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Octapharma’s FVIII concentrates in previously untreated and minimally treated haemophilia A patients

Recruiting

Open to: All Genders

Age: All

Bonn

Medical Conditions

Haemophilia A

This information is provided directly by researchers, and we recognise that it isn't always easy to understand. We are working with researchers to improve the accessibility of this information. In some summaries, you may come across links to external websites. These websites will have more information to help you better understand the study.


Haemophilia A results from an abnormality in the blood that affects its ability to clot. Blood clotting is the process that controls bleeding. It changes blood from a liquid to a solid form. This is a complex process involving many different blood chemicals or proteins, known as clotting factors. When certain clotting factors are missing or don't work properly, clotting of blood doesn't occur as it should.
In people with severe haemophilia A, an important clotting factor called factor VIII (FVIII) is missing or doesn't work the way it should. This causes people with haemophilia A to bleed for a longer time than people whose blood FVIII levels are normal. The preferred treatment for haemophilia A is a FVIII replacement therapy. Octapharma’s FVIII concentrates have been tested in clinical trials and registered for treatment of haemophilia A; however, as haemophilia A is a rare disease, only small numbers of patients have been treated. For previously untreated patients (PUPs), who are typically young children, and for minimally treated patients (MTPs), who have been exposed to only minimal FVIII dosages, more information is needed on treatment effectiveness and safety, specifically related to inhibitor development. Also, for PUPs, treatment algorithms are not standardized, e.g. with respect to utilisation, dosage, frequency or optimal start age of FVIII. The aim of this study is thus to evaluate product utilisation, effectiveness and safety, including inhibitor development, in severe haemophilia A PUPs and MTPs, who have been prescribed Octapharma’s FVIII concentrates.

Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.  

The recruitment start and end dates are as follows:

11 Feb 2018 30 Jun 2030

Publications

2023 Results article in https://doi.org/10.1055/s-0043-1768464 (added 15/05/2023)

This is an observational study, where treatment of severe haemophilia A patients is documented. For the FVIII concentrates evaluated, effectiveness is measured as the number of breakthrough bleeds during prophylactic treatment, and further FVIII utilization pattern (on-demand, surgery). Safety is assessed as the occurrence of hypersensitivity reactions and FVIII inhibitor development after treatment with any of Octapharma’s FVIII concentrates. In addition to the documentation of the individual treatment, there are sub-studies related to blood samples (taken during routine visits). The sub-study samples are analysed in central laboratories. The sub-studies provide additional information on the background of inhibitor development as well as on inhibitor eradication.

Each patient is observed for 100 exposure days to the chosen FVIII product. Frequency of treatment may vary from every other day to every two weeks. In patients developing a FVIII inhibitor, and where an immune tolerance induction is initiated, the maximum observational time is 3 years.


Patients with severe haemophilia A who have been prescribed Octapharma’s FVIII concentrate and who have never received a FVIII product before or have received a FVIII product for fewer than 5 days

You can take part if:



You may not be able to take part if:


1. Diagnosis with a coagulation disorder other than haemophilia A2. Concomitant treatment with any systemic immunosuppressive drug3. Participation in an interventional clinical trial during the time period evaluated4. Participation in another non-interventional study of Octapharma


Below are the locations for where you can take part in the trial. Please note that not all sites may be open.

  • Prof. Johannes Oldenburg, University Hospital Bonn
    Venusberg-Campus 1
    Bonn
    53127

Participation in this study will help to obtain additional information on the effectiveness and safety of the prescribed FVIII product, and the dosage regimens used, and may contribute towards the development of effective treatment strategies for future haemophilia A patients. Because this is a non-interventional study assessing a routine treatment, no additional risks are expected from being in the study. The FVIII product has been licensed. The study doctor will inform participants about possible risks, side effects and discomfort as part of the routine treatment information.

Mrs Martina Jansen
+43 664 9227867
martina.jansen@octapharma.com



The study is sponsored by Octapharma AG and funded by Octapharma AG (Switzerland).



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Read full details for Trial ID: ISRCTN11492145
Last updated 06 June 2024

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