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NCT04431726
A Study to Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of Subcutaneous Emicizumab in Participants From Birth to 12 Months of Age With Hemophilia A Without Inhibitors
Conditions: Severe Hemophilia A
Sex: All
Ages: 0 Months – 12 Months
Healthy volunteers: No
Phase: PHASE3
Enrollment: 55
Sponsor: Hoffmann-La Roche
Location: Phoenix Children's Hospital Phoenix Arizona
Summary
This is a Phase IIIb, multicenter, open-label, single-arm study of prophylactic emicizumab in previously untreated and minimally treated patients at study enrollment from birth to ≤12 months of age with severe hemophilia A (intrinsic factor VIII \[FVIII\] level \
Eligibility Criteria
Inclusion Criteria:
* Age from birth to ≤12 months at time of informed consent
* Body weight ≥3 kilograms (kg) at time of informed consent. Patients with a lower body weight can be enrolled after they have reached a body weight of 3 kg. Premature babies (gestational age \
Source: ClinicalTrials.gov (NCT04431726). StuddyBuddy aggregates publicly available trial information.
