Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: Phase 3, Prospective, Randomized, Multi-center Clinical Study Comparing the Safety and Efficacy of BAX 855 Following PK-guided Prophylaxis Targeting Two Different FVIII Trough Levels in Subjects With Severe Hemophilia A
Brief Summary: 1. To compare the efficacy and safety of pharmacokinetic (PK)-guided treatment with BAX 855 targeting FVIII trough levels of 1-3% and approximately 10% (8-12%)
2. To further characterize pharmacokinetic (PK) and pharmacodynamic (PD) parameters of BAX 855


Options:
A: Arm Label: Pharmacokinetic (PK) evaluation of BAX 855; Type: EXPERIMENTAL; Interventions: Biological: PEGylated Recombinant Factor VIII | Arm Label: FVIII trough target 1-3%; Type: EXPERIMENTAL; Interventions: Biological: PEGylated Recombinant Factor VIII | Arm Label: FVIII trough target 8-12%; Type: EXPERIMENTAL; Interventions: Biological: PEGylated Recombinant Factor VIII | Intervention Type: BIOLOGICAL; Name: PEGylated Recombinant Factor VIII; Assigned to Arm(s): Pharmacokinetic (PK) evaluation of BAX 855 | Intervention Type: BIOLOGICAL; Name: PEGylated Recombinant Factor VIII; Assigned to Arm(s): FVIII trough target 1-3% | Intervention Type: BIOLOGICAL; Name: PEGylated Recombinant Factor VIII; Assigned to Arm(s): FVIII trough target 8-12%
B: Arm Label: Arm 1: Recombinant Factor VIII (BAY81-8973) then Kogenate FS; Type: EXPERIMENTAL; Interventions: Biological: Recombinant Factor VIII (BAY81-8973) | Arm Label: Arm 2: Kogenate FS then Recombinant Factor VIII (BAY81-8973); Type: EXPERIMENTAL; Interventions: Biological: Recombinant Factor VIII (Kogenate FS, BAY14-2222) | Arm Label: Arm 3: Recombinant Factor VIII by CS/EP then by CS/ADJ; Type: EXPERIMENTAL; Interventions: Biological: Recombinant Factor VIII (BAY81-8973) | Arm Label: Arm 4: Recombinant Factor VIII by CS/ADJ then by CS/EP; Type: EXPERIMENTAL; Interventions: Biological: Recombinant Factor VIII (BAY81-8973) | Arm Label: Arm 5: Recombinant Factor VIII by CS/EP; Type: EXPERIMENTAL; Interventions: Biological: Recombinant Factor VIII (BAY81-8973) | Intervention Type: BIOLOGICAL; Name: Recombinant Factor VIII (BAY81-8973); Assigned to Arm(s): Arm 1: Recombinant Factor VIII (BAY81-8973) then Kogenate FS | Intervention Type: BIOLOGICAL; Name: Recombinant Factor VIII (Kogenate FS, BAY14-2222); Assigned to Arm(s): Arm 2: Kogenate FS then Recombinant Factor VIII (BAY81-8973) | Intervention Type: BIOLOGICAL; Name: Recombinant Factor VIII (BAY81-8973); Assigned to Arm(s): Arm 3: Recombinant Factor VIII by CS/EP then by CS/ADJ, Arm 4: Recombinant Factor VIII by CS/ADJ then by CS/EP | Intervention Type: BIOLOGICAL; Name: Recombinant Factor VIII (BAY81-8973); Assigned to Arm(s): Arm 5: Recombinant Factor VIII by 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: Concizumab; Type: EXPERIMENTAL; Interventions: Drug: Concizumab, Drug: placebo | Arm Label: Placebo; Type: PLACEBO_COMPARATOR; Interventions: Drug: placebo | Intervention Type: DRUG; Name: Concizumab; Assigned to Arm(s): Concizumab | Intervention Type: DRUG; Name: placebo; Assigned to Arm(s): Concizumab, Placebo

Answer: A