HEMLIBRA® clinical studies

Clinical trials are part of the drug discovery and development process. They play a key role in evaluating potential new medicines, including their safety and how well they work.

The efficacy of HEMLIBRA was studied in two clinical trials – HAVEN 1 and HAVEN 2 – in adults, adolescents, and children with hemophilia A with factor VIII inhibitors. HAVEN 2 is an ongoing study. The primary goal of each study was to determine how well HEMLIBRA worked in reducing the number of treated bleeds. Treated bleeds were defined as any bleed that received treatment with hemophilia medicine as determined by the individual, their caregiver, or their healthcare provider. The studies also evaluated the safety of HEMLIBRA, the effectiveness of HEMLIBRA compared to previous bypassing agent use, and how well the medicine worked in reducing the number of treated joint bleeds, spontaneous bleeds, and target joint bleeds.

HEMLIBRA was studied in 109 adult and adolescent males with hemophilia A (12 years to 75 years and weighing more than 40 kg) with factor VIII inhibitors. All had previously used bypassing agents, either as on-demand therapy or prophylaxis. The primary goal was to compare reduction in bleeds on HEMLIBRA to no prophylaxis.

The study was randomized, multicentered, and open-label. This means that participants were randomly assigned to separate groups for comparison across several different study locations, and each participant and his healthcare provider knew what therapy the participant was taking.

HEMLIBRA prophylaxis is being evaluated in a single-arm, multicenter, open-label study in children (younger than 12 or 12-17 years who weigh less than 40 kg) with hemophilia A with factor VIII inhibitors. (Single-arm means that everyone received the same therapy; in this case, HEMLIBRA.)

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