Frequently Asked Questions (FAQs)
About Azalea
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Azalea is evaluating an investigational medication for pregnancies at risk for severe hemolytic disease of the fetus and newborn (HDFN). You may be able to take part in this trial if you:
- Have tested positive for red cell antibodies
- Have been diagnosed with HDFN in a prior pregnancy
- Are 18 to 45 years old
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The trial will involve weekly visits to the trial clinic, which take place over the course of several months. During each visit, the investigational medication (or placebo) will be administered and participants will complete a variety of other health exams and tests.
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If eligible, participation can last up to 135 weeks (about 2.5 years).
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The investigational medication is a sterile solution that will be administered as an IV infusion at your visits.
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Do not discontinue any medication unless you are advised to do so by the trial clinic staff or your primary care provider.
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There is no cost to you for participating.
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Clinical trials are designed in specific ways, and one or more of the answers that you provided were outside of the guidelines for this trial. This does not mean you will not qualify for different research trials.
About Clinical Research
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A clinical trial is a carefully designed scientific evaluation of an investigational medication or treatment that is conducted by doctors and researchers.
Trials are conducted in 4 phases:
- Phase 1 trials generally examine the safety of an investigational medication in healthy people.
- Phase 2 trials involve the assessment of safety, efficacy, and establishing the appropriate dosing regimens in participants.
- Phase 3 trials confirm the efficacy and safety of an investigational medication in participants.
- Phase 4 trials are conducted after an investigational medication has been approved to gather additional efficacy and safety information.
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Activities vary from one clinical trial to the next, but most require regular medical examinations. Some trials involve taking either an approved or investigational medication, while others involve a procedure. Your trial doctor will discuss these details with you. You may be asked to record information about how you are doing. You also may be asked to return for follow-up visits to evaluate whether the research is producing the intended results.
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The purpose of this trial is to evaluate the safety and efficacy of an investigational medication in pregnancies at risk for severe HDFN. A clinical trial may or may not help you personally, but it will provide researchers with valuable information about treating HDFN in the future.
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Each clinical trial has a well-documented plan, or protocol, about what you will need to know and what is expected. Your trial team will keep you fully informed about the plan, including all known potential benefits and risks of the research. If there is a change in your or your baby’s health while you are participating, the trial doctor will inform you immediately and will discuss your options, as your physical and mental health are of paramount importance. You are encouraged to ask any questions at any time. If you decide to participate, you will be asked to sign an informed consent form.
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Research is conducted for many years before an investigational medication advances to a clinical trial. Negative effects are possible. You will be fully informed of all known risks and the potential for unknown risks before you start. During the trial, your trial team will carefully monitor the health and safety of you and your baby. You should report any concerns to your trial doctor.
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You can withdraw from the trial at any time, for any reason. Even if you begin the trial, you can change your mind at any point. The trial doctor will discuss your care options with you if you decide to withdraw.