Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: A Phase II/III, Randomized, Cross-over, Open-label Trial to Demonstrate Superiority of Prophylaxis Over On-demand Therapy in Previously Treated Subjects With Severe Hemophilia A Treated With Plasma Protein-free Recombinant FVIII Formulated With Sucrose (BAY 81-8973)
Brief Summary: The objective of the trial is to demonstrate that 2-3 times per week prophylaxis therapy with BAY81-8973 is superior to on-demand therapy with BAY81-8973 in patients with severe Hemophilia A. The hypothesis is that prophylaxis will result in fewer bleeds than on-demand treatment.


Options:
A: Arm Label: N9-GP; Type: EXPERIMENTAL; Interventions: Drug: N9-GP | Arm Label: ALPROLIX®; Type: ACTIVE_COMPARATOR; Interventions: Drug: ALPROLIX® | Intervention Type: DRUG; Name: N9-GP; Assigned to Arm(s): N9-GP | Intervention Type: DRUG; Name: ALPROLIX®; Assigned to Arm(s): ALPROLIX®
B: Arm Label: Arm 1: rFVIII on demand first CS/EP then CS/ADJ; Type: EXPERIMENTAL; Interventions: Biological: rFVIII (BAY81-8973) on demand | Arm Label: Arm 2: rFVIII on demand first CS/ADJ then CS/EP; Type: EXPERIMENTAL; Interventions: Biological: rFVIII (BAY81-8973) on demand | Arm Label: Arm 3: rFVIII prophylaxis low-dose first CS/EP then CS/ADJ; Type: EXPERIMENTAL; Interventions: Biological: rFVIII (BAY81-8973) prophylaxis low-dose | Arm Label: Arm 4: rFVIII prophylaxis low-dose first CS/ADJ then CS/EP; Type: EXPERIMENTAL; Interventions: Biological: rFVIII (BAY81-8973) prophylaxis low-dose | Arm Label: Arm 5: rFVIII prophylaxis high-dose first CS/EP then CS/ADJ; Type: EXPERIMENTAL; Interventions: Biological: rFVIII (BAY81-8973) prophylaxis high-dose | Arm Label: Arm 6: rFVIII prophylaxis high-dose first CS/ADJ then CS/EP; Type: EXPERIMENTAL; Interventions: Biological: rFVIII (BAY81-8973) prophylaxis high-dose | Intervention Type: BIOLOGICAL; Name: rFVIII (BAY81-8973) on demand; Assigned to Arm(s): Arm 1: rFVIII on demand first CS/EP then CS/ADJ, Arm 2: rFVIII on demand first CS/ADJ then CS/EP | Intervention Type: BIOLOGICAL; Name: rFVIII (BAY81-8973) prophylaxis low-dose; Assigned to Arm(s): Arm 3: rFVIII prophylaxis low-dose first CS/EP then CS/ADJ, Arm 4: rFVIII prophylaxis low-dose first CS/ADJ then CS/EP | Intervention Type: BIOLOGICAL; Name: rFVIII (BAY81-8973) prophylaxis high-dose; Assigned to Arm(s): Arm 5: rFVIII prophylaxis high-dose first CS/EP then CS/ADJ, Arm 6: rFVIII prophylaxis high-dose first CS/ADJ then CS/EP
C: Arm Label: Individualized (Tailored) Prophylaxis; Type: EXPERIMENTAL; Interventions: Drug: Factor VIII (rFVIIIFc), Drug: Advate® | Arm Label: Weekly Prophylaxis; Type: EXPERIMENTAL; Interventions: Drug: Factor VIII (rFVIIIFc) | Arm Label: Episodic (On-Demand) Dosing; Type: EXPERIMENTAL; Interventions: Drug: Factor VIII (rFVIIIFc) | Intervention Type: DRUG; Name: Factor VIII (rFVIIIFc); Assigned to Arm(s): Episodic (On-Demand) Dosing, Individualized (Tailored) Prophylaxis, Weekly Prophylaxis | Intervention Type: DRUG; Name: Advate®; Assigned to Arm(s): Individualized (Tailored) Prophylaxis
D: Arm Label: BAY94-9027 and Elocta; Type: EXPERIMENTAL; Interventions: Drug: Damoctocog (Jivi, BAY94-9027), Drug: Elocta | Arm Label: Elocta and BAY94-9027; Type: EXPERIMENTAL; Interventions: Drug: Damoctocog (Jivi, BAY94-9027), Drug: Elocta | Intervention Type: DRUG; Name: Damoctocog (Jivi, BAY94-9027); Assigned to Arm(s): BAY94-9027 and Elocta, Elocta and BAY94-9027 | Intervention Type: DRUG; Name: Elocta; Assigned to Arm(s): BAY94-9027 and Elocta, Elocta and BAY94-9027

Answer: B