Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Hoffmann-La Roche
With
Chugai Pharmaceutical
Age
12–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Body weight \>/= 40 kilogram (kg) at the time of screening
Diagnosis of severe congenital hemophilia A
Documentation of the details of prophylactic or episodic FVIII treatment and of number of bleeding episodes for at least the last 24 weeks
Adequate hematologic function
Adequate hepatic function
Adequate renal function
For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive methods that result in a failure rate of less than (\<) 1 percent (%) per year during the treatment period and for at least 5 elimination half-lives (24 weeks) after the last dose of study drug
You may not be if
Inherited or acquired bleeding disorder other than hemophilia A
Previous or current treatment for thromboembolic disease or signs of thromboembolic disease
Conditions that may increase risk of bleeding or thrombosis
History of clinically significant hypersensitivity associated with monoclonal antibody therapies or components of the emicizumab injection
Known human immunodeficiency virus (HIV) infection with cluster of differentiation (CD) 4 count \<200 cells per microliter (cells/mcL) within 24 weeks prior to screening. Participants with HIV infection who has CD4 greater than (\>) 200 and meet all other criteria are eligible
Use of systemic immunomodulators at enrollment or planned use during the study, with the exception of anti-retroviral therapy
Participants who are at high risk for thrombotic microangiopathy (TMA) (for example, have a previous medical or family history of TMA), in the investigator's judgment
Concurrent disease, treatment, or abnormality in clinical laboratory tests that could interfere with the conduct of the study, may pose additional risk, or would, in the opinion of the investigator, preclude the participant's safe participation in and completion of the study
Planned surgery (excluding minor procedures) during the study
Receipt of emicizumab in a prior investigational study; an investigational drug to treat or reduce the risk of hemophilic bleeds within 5 half-lives of last drug administration; a non-hemophilia-related investigational drug concurrently, within last 30 days or 5 half-lives, whichever is shorter
Pregnant or lactating, or intending to become pregnant during the study
Clareo Health | A Clinical Trial to Evaluate Prophylactic Emicizumab Versus no Prophylaxis in Hemophilia A Participants Without Inhibitors
