Study to assess the safety, pharmacokinetics and efficacy of HMPL-523 in patients with Immune Thrombocytopenia
This research study is testing a new medicine, HMPL-523, for grown-ups who have a condition called immune thrombocytopenia, or ITP. ITP is a blood disorder where your body's immune system mistakenly attacks and destroys your platelets, which are tiny cells that help your blood to clot. This can lead to easy bruising and bleeding. The main goals of this study are to make sure the new medicine is safe to use, to understand how it behaves in the body, and to see if it can improve the health of people living with ITP. It's an early-stage study, meaning it's one of the first times this medicine is being tested in humans.
At a glance
What is this study about?
This study is about a new medication, HMPL-523, for a condition called immune thrombocytopenia, or ITP. If you have ITP, it means your body's defence system, called the immune system, mistakenly attacks and destroys your platelets. Platelets are tiny blood cells that help your blood clot when you get a cut or bruise. When you don't have enough platelets, you might bruise easily, bleed more than usual, or have tiny red spots on your skin.
The main purpose of this study is to learn more about HMPL-523. Researchers want to find out if it's safe for people to take, how it moves through the body, and whether it can help to increase platelet counts in people with ITP. This is an early phase of research, which means it’s one of the first times this particular medicine is being given to people. Studies like this are very important steps in developing new treatments that could one day help many more patients.
By taking part, you would be helping doctors and scientists better understand ITP and explore new ways to manage it. Even if this new medicine doesn't fully cure ITP, finding a treatment that helps improve platelet counts and reduces symptoms could make a big difference to people's quality of life.
Key takeaways
- This study is testing a new medicine (HMPL-523) for adults with ITP.
- It's an early-stage study focused on safety and how the medicine works.
- The goal is to see if HMPL-523 can help improve platelet counts in ITP.
- Participation involves regular visits and medical assessments.
- You must be 18 years or older to take part.
- You have the right to leave the study at any time.
Who may be eligible?
To be able to join this study, you must be 18 years old or older. The study is open to both men and women.
Beyond these basic requirements, the specific details of your ITP condition and your overall health will be carefully checked by the study doctors. They will look at things like how long you've had ITP, what treatments you might have tried in the past, and other general health measures to make sure the study is a safe and suitable option for you.
It's important to remember that not everyone with ITP will be able to join. The doctors will review your medical history and test results to see if you meet all the criteria for taking part. This helps ensure your safety and the accuracy of the study's results.
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?
- Have you been diagnosed with primary immune thrombocytopenia (ITP)?
- Are you prepared to attend regular clinic visits for medical checks?
- Are you able to understand and agree to the study procedures?
What does participation involve?
If you decide to take part in this study, you would first have a screening visit to check if you meet all the requirements. If you do, you would then start the study treatment, which involves taking the investigational medicine, HMPL-523. You would have regular visits to the study clinic for assessments. These visits might include blood tests to check your platelet count and overall health, physical examinations, and questions about how you are feeling and any side effects you might be experiencing. The study team will explain how often these visits are and what they involve.
You would receive the study medication as directed by the research team. The study will also involve follow-up visits after you finish taking the medication to make sure everything is stable. The total length of your participation, including screening, treatment, and follow-up, will be fully explained by the study team before you decide to join.
Potential risks and benefits
Locations (3)
- —UnverifiedNorway
- —UnverifiedSpain
- —UnverifiedGermany
Common questions
What is ITP?
ITP stands for Immune Thrombocytopenia. It's a blood disorder where your body's immune system mistakenly attacks and destroys your platelets, which are tiny cells that help your blood clot.
What is HMPL-523?
HMPL-523 is the name of the new medicine being tested in this study. It's designed to see if it can help people with ITP by affecting their platelet counts.
Is this medicine approved for ITP?
No, HMPL-523 is not yet approved. This is an early-stage study to gather information on its safety and how well it works before it can be considered for wider use.
Will I know if I'm getting the active medicine?
For early-stage studies like this, all participants often receive the active study medicine. The research team will explain the specific details of how the medicine is given.
Will I have to pay to join the study?
No, you will not have to pay to participate in the study. All study-related medication, doctor visits, and tests are provided at no cost to you.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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