A Phase 3 Open Label Extension Study of Fostamatinib Disodium in the Treatment of Warm Antibody Autoimmune Hemolytic Anemia
If you have a condition called warm antibody autoimmune haemolytic anaemia (wAIHA) and have previously taken part in a particular study (C-935788-057), this research might be for you. This trial is checking the long-term safety of a medicine called fostamatinib disodium. It's a 'Phase 3' study, which means the medicine has already been through earlier tests. The main goal is to understand how safe fostamatinib is when taken for an extended period by people with this type of anaemia. This is an 'open-label' study, meaning everyone involved will know they are receiving the study medicine.
At a glance
What is this study about?
This research is looking further into a medicine called fostamatinib for people who have a blood condition called warm antibody autoimmune haemolytic anaemia (wAIHA). In this condition, your body's immune system mistakenly attacks and destroys your red blood cells too quickly. This can lead to anaemia, making you feel very tired and weak.
Fostamatinib has already been tested in earlier studies, and this 'Phase 3' trial is designed to gather more information. Specifically, it's an 'open-label extension study.' This means that everyone taking part will receive fostamatinib, and both you and the study doctors will know you are taking the actual medicine. The main reason for this particular study is to see how safe the medicine is when taken over a longer period.
Understanding the long-term safety of medicines is really important. It helps doctors and patients make informed decisions about treatments in the future. By continuing to follow people who have already used fostamatinib, researchers can build a more complete picture of its effects over time.
Key takeaways
- This study is for adults with a specific type of anaemia (wAIHA).
- It's about a medicine called fostamatinib for continued treatment.
- The main focus is understanding the long-term safety of the medicine.
- Participation requires you to have completed a previous related study.
- It's an 'open-label' study, so everyone knows they're taking the medicine.
Who may be eligible?
To be considered for this study, you must be an adult, aged between 18 and 100 years old. Both men and women are welcome to take part.
A key requirement is that you must have previously participated in a specific earlier study related to this condition, known as study C-935788-057. Not only must you have been in that study, but you also needed to have completed all 24 weeks of it.
If you stopped taking part in the previous study before completing the full 24 weeks, you would not be able to join this current study. All participants must also be willing to read and sign a consent form, showing they understand the study and agree to take part.
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 aged 18 to 100 years old?
- Do you have warm antibody autoimmune haemolytic anaemia (wAIHA)?
- Have you previously taken part in and COMPLETED all 24 weeks of study C-935788-057?
- Are you willing to sign a consent form to participate?
What does participation involve?
As this is an 'extension' study, you would already be familiar with taking fostamatinib from a previous trial. The study would involve continuing to take the fostamatinib disodium medication. You would have regular appointments at a clinic or hospital for check-ups. These visits would likely include blood tests to monitor your health and how the medicine is affecting your condition. You would also answer questions about how you are feeling and any side effects you might be experiencing. The total duration of your participation would depend on the study plan, which aims to evaluate the long-term safety of the drug.
Potential risks and benefits
Locations (37)
- University of Southern California - Janice and Robert Hall Clinical Trials Biospecimen LaboratoryVerified postcodeLos Angeles, United States
- Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical CenterVerified postcodeTorrance, United States
- Lombardi Comprehensive Cancer CenterVerified postcodeWashington D.C., United States
- John Hopkins Bayview Medical CenterVerified postcodeBaltimore, United States
- Massachusetts General HospitalVerified postcodeBoston, United States
- Comprehensive Cancer Centers of NevadaVerified postcodeLas Vegas, United States
- American Oncology Network Vista Oncology DivisionVerified postcodeOlympia, United States
- University of WashingtonVerified postcodeSeattle, United States
- Princess Alexandra Hospital - Cancer Trials UnitVerified postcodeBrisbane, Australia
- The Alfred HospitalVerified postcodeMelbourne, Australia
- Hanusch-KrankenhausVerified postcodeVienna, Austria
- Universitätsklinik f. Innere Medizin I - Klin. Abt. f. Hämatologie u. HämostaseologieVerified postcodeVienna, Austria
Common questions
What is 'warm antibody autoimmune haemolytic anaemia'?
It's a condition where your body's immune system mistakenly attacks and destroys your red blood cells, leading to anaemia.
What is fostamatinib disodium?
It's the specific medicine being studied in this trial to see how it helps treat wAIHA over time.
What does 'Phase 3' mean for a study?
It means the medicine has already been tested in smaller groups, and now researchers are gathering more information about its safety and effectiveness in a larger group before it becomes widely available.
What does 'open-label' mean?
It means both you and the doctors involved in the study will know that you are receiving the fostamatinib medicine, not a placebo (dummy pill).
What is the main goal of this particular study?
The main goal is to find out how safe fostamatinib is for people with wAIHA when they take it for a long period.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
Discussion
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