Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: A-LONG: An Open-Label, Multicenter Evaluation of the Safety, Pharmacokinetics, and Efficacy of Recombinant Factor VIII Fc Fusion Protein (rFVIIIFc) in the Prevention and Treatment of Bleeding in Previously Treated Subjects With Severe Hemophilia A
Brief Summary: The primary objectives of this study are: to evaluate the safety and tolerability of rFVIIIFc administered as a prophylaxis (Arm 1), weekly (Arm 2), on-demand (Arm 3), and surgical treatment regimen; to evaluate the efficacy of the rFVIIIFc tailored prophylaxis regimen (Arm 1); to evaluate the efficacy of rFVIIIFc administered as an on-demand (Arm 3) and surgical treatment regimen. The secondary objectives of this study are: to characterize the PK profile of rFVIIIFc and compare the PK of rFVIIIFc with the currently marketed product, Advate®; to characterize the range of dose and schedules required to adequately prevent bleeding in a prophylaxis regimen, maintain hemostasis in a surgical setting, or to treat bleeding episodes in an on-demand, weekly treatment, or prophylaxis setting.


Options:
A: Arm Label: Prophylaxis, high dose (trial duration 52 weeks); Type: EXPERIMENTAL; Interventions: Drug: nonacog beta pegol | Arm Label: Prophylaxis, low dose (trial duration 52 weeks); Type: EXPERIMENTAL; Interventions: Drug: nonacog beta pegol | Arm Label: On-demand (trial duration 28 weeks); Type: EXPERIMENTAL; Interventions: Drug: nonacog beta pegol | Intervention Type: DRUG; Name: nonacog beta pegol; Assigned to Arm(s): Prophylaxis, high dose (trial duration 52 weeks) | Intervention Type: DRUG; Name: nonacog beta pegol; Assigned to Arm(s): Prophylaxis, low dose (trial duration 52 weeks) | Intervention Type: DRUG; Name: nonacog beta pegol; Assigned to Arm(s): On-demand (trial duration 28 weeks)
B: 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
C: 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
D: Arm Label: A; Type: EXPERIMENTAL; Interventions: Drug: Recombinant Coagulation Factor IX (BeneFIX) | Arm Label: B; Type: EXPERIMENTAL; Interventions: Drug: Recombinant Coagulation Factor IX (BeneFIX) | Intervention Type: DRUG; Name: Recombinant Coagulation Factor IX (BeneFIX); Assigned to Arm(s): A | Intervention Type: DRUG; Name: Recombinant Coagulation Factor IX (BeneFIX); Assigned to Arm(s): B

Answer: B