{"id":23,"date":"2024-06-06T18:05:42","date_gmt":"2024-06-06T18:05:42","guid":{"rendered":"https:\/\/stgbeyond9.wpenginepowered.com\/?page_id=23"},"modified":"2025-07-31T09:37:15","modified_gmt":"2025-07-31T09:37:15","slug":"faq","status":"publish","type":"page","link":"http:\/\/hemophilia-beyond-9.com\/en-ca\/faq\/","title":{"rendered":"FAQs"},"content":{"rendered":"\t\t
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FAQs <\/h1>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t
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\n\t\t\t\t\t\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/path><\/svg><\/span>\n\t\t\t\t\t\t\t\t<\/path><\/svg><\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t\t\tWhat is a clinical research study?\u00a0<\/a>\n\t\t\t\t\t<\/div>\n\n\t\t\t\t\t

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\u2019s the Food and Drug Administration (FDA). In Europe, it\u2019s the European Medicines Agency (EMA). Agencies vary by region. They decide whether to approve the investigational treatment for doctors to prescribe.\u00a0<\/p>

The first step is discovering and developing an investigational medicine to study. After that, clinical studies test to see if it is well tolerated 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.\u00a0<\/p><\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t\t

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\n\t\t\t\t\t\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/path><\/svg><\/span>\n\t\t\t\t\t\t\t\t<\/path><\/svg><\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t\t\tWhat is the BEYOND-9 study?\u00a0 <\/a>\n\t\t\t\t\t<\/div>\n\n\t\t\t\t\t

For more information regarding the study, visit the About BEYOND-9<\/a> section.<\/p><\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t\t

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\n\t\t\t\t\t\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/path><\/svg><\/span>\n\t\t\t\t\t\t\t\t<\/path><\/svg><\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t\t\tAm I eligible to take part in the BEYOND-9 study?\u00a0<\/a>\n\t\t\t\t\t<\/div>\n\n\t\t\t\t\t

To see if you are eligible, take our questionnaire in the Am I eligible?<\/a> section.<\/p><\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t\t

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\n\t\t\t\t\t\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/path><\/svg><\/span>\n\t\t\t\t\t\t\t\t<\/path><\/svg><\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t\t\tWhy are women excluded from the BEYOND-9 study?\u00a0 <\/a>\n\t\t\t\t\t<\/div>\n\n\t\t\t\t\t

The FIX protein is expressed by a gene located on the X chromosome. As males have only one X chromosome and no second copy of the gene, severe hemophilia more often affects males.\u00a0<\/p><\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t\t

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\n\t\t\t\t\t\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/path><\/svg><\/span>\n\t\t\t\t\t\t\t\t<\/path><\/svg><\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t\t\tHow many people will be taking part in the BEYOND-9 study?\u00a0<\/a>\n\t\t\t\t\t<\/div>\n\n\t\t\t\t\t

Up to approximately 120 people worldwide are expected to participate. To find your nearest study site, please visit our Site finder<\/a>.<\/p><\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t\t

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\n\t\t\t\t\t\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/path><\/svg><\/span>\n\t\t\t\t\t\t\t\t<\/path><\/svg><\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t\t\tWhat are my responsibilities if I take part?\u00a0<\/a>\n\t\t\t\t\t<\/div>\n\n\t\t\t\t\t

If you join the study, there are certain things you will be expected to do. This includes, but is not limited to<\/strong>, attending study visits, getting your body weight, height, temperature, blood pressure and respiration rate taken by your study team, getting a scan of your liver to see if it\u2019s healthy, telling your doctor when you experience bleeding that requires additional treatment, and getting your blood drawn for some tests.\u00a0<\/p><\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t\t

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BEYOND-9 may last up to approximately 2 years and 8 months. Participation may last longer (up to 4 years and 2 months) depending on time spent in the lead-in period. Additionally, if you enroll and receive the investigational treatment, you will be asked to join a long-term follow-up study lasting 15 years.\u00a0<\/strong><\/p><\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t\t

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You will help us increase our medical understanding of hemophilia B which may benefit others in the future with this condition.\u00a0<\/p><\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t\t

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\n\t\t\t\t\t\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/path><\/svg><\/span>\n\t\t\t\t\t\t\t\t<\/path><\/svg><\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t\t\tWhat are potential risks of joining?\u00a0<\/a>\n\t\t\t\t\t<\/div>\n\n\t\t\t\t\t

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.\u00a0<\/p>

Clinical studies are 100% voluntary. You can stop at any time.\u00a0<\/p><\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t\t

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The study is taking place in multiple countries worldwide. To find a study site near you, visit our Site finder<\/a>.<\/p><\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t\t\t