Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: An Open-Label, Multicenter Evaluation of Safety, Pharmacokinetics, and Efficacy of Recombinant Coagulation Factor VIII Fc Fusion Protein, BIIB031, in the Prevention and Treatment of Bleeding Episodes in Pediatric Subjects With Hemophilia A
Brief Summary: The primary objective of the study is to evaluate the safety of Recombinant Coagulation Factor VIII Fc Fusion Protein (rFVIIIFc) in previously treated pediatric subjects with hemophilia A. Secondary objectives of this study in this study population are as follows: to evaluate the efficacy of rFVIIIFc for prevention and treatment of bleeding episodes; to evaluate and assess the pharmacokinetics (PK) of rFVIIIFc; and to evaluate rFVIIIFc consumption for prevention and treatment of bleeding episodes.


Options:
A: Arm Label: All participants; Type: EXPERIMENTAL; Interventions: Drug: BIIB031 (rFVIIIFc), Drug: FVIII (PK subgroup only) | Intervention Type: DRUG; Name: BIIB031 (rFVIIIFc); Assigned to Arm(s): All participants | Intervention Type: DRUG; Name: FVIII (PK subgroup only); Assigned to Arm(s): All participants
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: On-Demand; Type: EXPERIMENTAL; Interventions: Drug: rFVIIIFc | Arm Label: Prophylaxis; Type: EXPERIMENTAL; Interventions: Drug: rFVIIIFc | Intervention Type: DRUG; Name: rFVIIIFc; Assigned to Arm(s): On-Demand, Prophylaxis
D: Arm Label: Group 1; Type: N/A; Interventions: Drug: Recombinant Factor VIII (Kogenate FS, BAY14-2222) | Arm Label: Group 2; Type: N/A; Interventions: Drug: Recombinant Factor VIII (Kogenate FS, BAY14-2222) | Intervention Type: DRUG; Name: Recombinant Factor VIII (Kogenate FS, BAY14-2222); Assigned to Arm(s): Group 1 | Intervention Type: DRUG; Name: Recombinant Factor VIII (Kogenate FS, BAY14-2222); Assigned to Arm(s): Group 2

Answer: A