FAQS

A clinical research study is a medical research study in people. The potential new treatment or device being studied only enters a clinical study after researchers test it in the laboratory. If it looks promising, scientists carefully test and collect data about the potential treatment through clinical studies. A clinical study helps us learn how an investigational treatment works in the body. Clinical studies must be reviewed by a regulatory agency. In the United States, it’s the Food and Drug Administration (FDA). In Europe, it’s the European Medicines Agency (EMA). Agencies vary by region. They decide whether to approve the investigational treatment for doctors to prescribe.

The first step is discovering and developing a new investigational medicine to study. After that, clinical studies show if it is safe and effective and provide information on any side effects. Sometimes, researchers compare the potential medicine to a placebo. The placebo looks and is administered like the potential treatment but has no active ingredients. The potential treatment may also be compared to a standard treatment that is already approved and used for treatment. They compare it to current treatments, if available, to find out if the potential treatment is better.

For more information regarding the study, visit the About FERVENT-1 section.

To see if you are eligible, take our questionnaire in the Can I take part? section.

Approximately 95 people worldwide are expected to participate. To find your nearest study site, please visit our Site finder.

If you choose to take part in the FERVENT-1 study, you will be asked to attend all study visits and keep the study team informed of your contact information and which medications you are taking. There are more responsibilities when taking part in the FERVENT-1 study, which you will learn more about if you choose to take part. Please talk to the study team about any questions or concerns you may have.

Your participation may last around a year and a half with up to 22 study visits.

You may benefit by receiving additional health check-ups on top of your regular medical care. You will also help us increase our medical understanding of non-transfusion dependent beta-thalassemia, which may benefit others in the future with this condition.

The Informed Consent Form talks about all known risks. Before starting a clinical study, you must sign the document. Signing it means you agree to participate in the research study. The study staff will walk you through the study schedule and design. Ask questions so you are comfortable moving forward.

Clinical studies are 100% voluntary. You can stop at any time.

The study is taking place in multiple countries worldwide. To find a study site near you, visit our Site finder.

If you have additional questions about taking part in this study, you can share this website with your doctor to discuss this clinical research study. Additionally, you can also contact a clinical site near you: Site finder.

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