Exploratory Study of Ianalumab in Adults with Primary Immune Thrombocytopenia (ITP) and Warm-antibody Autoimmune Hemolytic Anemia (wAIHA) who Have Previously Benefited from Ianalumab (VAY RE-HIT)
This research study, called VAY RE-HIT, is looking into a medication named ianalumab for adults who have two specific blood conditions: Immune Thrombocytopenia (ITP) or Warm Autoimmune Hemolytic Anemia (wAIHA). The study is for people who have already had some benefit from ianalumab in the past. Researchers want to understand how often people with ITP remain free from their condition getting worse over a year after a second course of treatment. For those with wAIHA, they want to see how many achieve a lasting improvement in their red blood cell levels without needing other treatments. The study also tracks any side effects and how the body handles the medicine.
At a glance
What is this study about?
This study is called VAY RE-HIT, and it's looking at a medicine named ianalumab. It's for adults who have two types of blood conditions: Immune Thrombocytopenia (ITP) or Warm Autoimmune Hemolytic Anemia (wAIHA). If you have ITP, your body doesn't have enough platelets, which are tiny cells that help your blood clot. If you have wAIHA, your body mistakenly attacks and destroys its own red blood cells too quickly.
The main aim of this study is to see how well ianalumab works over a longer period for people who have already used it before and found it helpful. For those with ITP, the researchers want to know how many people stay well, meaning their platelet counts remain at a healthy level and they don't need other treatments, for a year after a second course of ianalumab. For people with wAIHA, they want to see how many keep a good level of red blood cells for a period of eight weeks or more. They are also carefully watching for any side effects of the medicine.
Understanding how medicines work long-term is really important. This study will help doctors learn more about ianalumab and how it might help people with ITP and wAIHA live healthier lives with fewer symptoms. The information gathered will contribute to better understanding and possibly improving treatments for these conditions in the future.
Key takeaways
- The study explores a medicine called ianalumab for ITP and wAIHA.
- It's for adults who have used ianalumab before and found it helpful.
- Researchers will track how well participants stay symptom-free or improve, and look for side effects.
- Participation involves regular clinic visits, blood tests, and health checks.
- The goal is to understand the long-term benefits and safety of ianalumab.
Who may be eligible?
This study is for adults, meaning you must be 18 years old or older to take part. Both men and women are welcome to participate.
Crucially, this study is designed for people who have already been treated with ianalumab in the past and found it to be beneficial for their ITP or wAIHA. It's looking at what happens when you have a second course of the treatment.
There might be other specific health requirements or conditions that would mean you can or cannot join the study, so it's important to discuss this carefully with your doctor.
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 18 years old or older?
- Do you have a diagnosis of Immune Thrombocytopenia (ITP) or Warm Autoimmune Hemolytic Anemia (wAIHA)?
- Have you previously received treatment with ianalumab?
- Did you experience some benefit from your previous ianalumab treatment?
- Are you willing and able to attend regular clinic visits and have blood tests?
What does participation involve?
If you join this study, you would receive a medicine called ianalumab. The study is particularly interested in people who have had ianalumab before and found it helpful, so it looks at giving a second course of treatment. Regularly, you would have clinic visits where doctors would perform health checks, take blood samples to measure your blood counts (like platelets or red blood cells) and check how the medicine is affecting you. They will also look for any side effects. You might also be asked to answer questions about how you are feeling generally. The total duration of your participation in the study, including follow-up, would be decided by the study protocol, but it involves monitoring your condition and the effects of ianalumab over a period, potentially up to a year or more, depending on your particular condition and response.
Potential risks and benefits
Locations (9)
- —UnverifiedGermany
- —UnverifiedCzechia
- —UnverifiedBelgium
- —UnverifiedSpain
- —UnverifiedItaly
- —UnverifiedBulgaria
- —UnverifiedRomania
- —UnverifiedFrance
- —UnverifiedHungary
Common questions
What is ITP?
ITP stands for Immune Thrombocytopenia. It's a blood condition where your immune system mistakenly attacks and destroys your platelets, which are cells that help your blood clot.
What is wAIHA?
wAIHA stands for Warm Autoimmune Hemolytic Anemia. It's a condition where your body's immune system attacks and destroys your own red blood cells too quickly, leading to anaemia.
What is ianalumab?
Ianalumab is the name of the medicine being studied. The researchers want to learn more about how it works for people with ITP or wAIHA.
Why is this study only for people who had ianalumab before?
This study is designed to see if a second course of ianalumab continues to be helpful for people who have benefited from it in the past, helping doctors understand its longer-term effects.
Will I have to pay to be in the study?
No, you will not have to pay for the study medication or procedures related to the study. However, some travel costs may or may not be covered depending on the specific study site – this is something to clarify with the study team.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Discussion
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