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.
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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 …
Contacts

Amy D Shapiro, MD

3178710000

ashapiro@ihtc.org

CONTACT

Usha Sirimalle, MS

3178710000

usirimalle@ihtc.org

CONTACT