Hemlibra in Mild Hemophilia A
Recruiting
Phase 4
Interventional Study
Factor VIII Deficiency, Congenital
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 5 – 45
- Sex
- Male
- Trial phase
- Phase 4
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 20 (estimated)
- Sponsor
- Indiana Hemophilia &Thrombosis Center, Inc. · Other
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About This Trial
This is a single arm, phase 4, prospective, open-label, United States single-center study to determine the hemostatic characteristics of Hemlibra (emicizumab) as measured by coagulation laboratory parameters in the mild hemophilia A male patient population with endogenous altered FVIII (baseline FVIII activity of \>5% to 30%). The safety and hemostatic efficacy of Hemlibra (emicizumab) in this pat…
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
* Signed informed consent form from the subject, parent or guardian
* Male sex
* Diagnosis of mild congenital hemophilia A (baseline FVIII level of \>5% to 30%) without a current FVIII inhibitor or a history of FVIII inhibitor
* Any number of FVIII exposure days, including PUPs
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Contacts