What You Can Expect
What happens during the study?
Before starting the study, you will need to read and sign an Informed Consent Form that documents your willingness to participate.
Screening Period
The study doctor will then collect information and run tests to see if you are eligible for the study. You will also be required to be up to date with certain vaccinations in order to lower your risk of infection.
Treatment Period
26 Weeks
If eligible, you will be randomly assigned to receive:
Study drug combination
(Investigational Study Drugs A + B)*
or
Eculizumab
During the Treatment Period, you will have study visits to check on your health.
Home healthcare or virtual visits may be available for certain visits.
*The first dose of Investigational Study Drug A is given as an infusion.
How are the treatments given?
The investigational study drugs are injected under the skin.
(The first dose of Investigational Study Drug A is given as an infusion).
The study staff may be able to train you or a caregiver on how to give your injections at home.
Eculizumab is given as infusions into a vein.
You may also be asked to take antibiotics every day while receiving the study drug treatment and for 1 year after your final dose to help lower the risk of infection (based on the advice of your doctor).
What kind of tests will I have at study visits?
Some of the tests you will have during the study include:
Physical exam
Vital signs
Weight
Blood tests
Heart activity
(electrocardiogram)
Questionnaires
You will not have all of these tests at each visit.
There may also be some additional tests. Talk to the study doctor for more information.
You will be monitored continuously throughout the study for any changes in health or potential side effects.
Being in a clinical research study is voluntary and you can choose to leave at any time.
For more information about the ACCESS-1 Study:
Call +353 (0) 61 533 400
or
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