Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: Advate Antihemophilic Factor (Recombinant), Plasma/Albumin Free Method (ADVATE rAHF-PFM): A Phase 4 Study Comparing Two Prophylactic Regimens in Subjects With Severe or Moderately Severe Hemophilia A
Brief Summary: The primary purpose of this randomized, two-arm parallel clinical study in 66 previously treated patients with severe or moderately severe hemophilia A is to compare the rate of bleeding episodes for standard prophylaxis (20-40 IU/kg every 48 ± 6 hours; actual dose determined by the investigator) with that of alternate prophylaxis (20-80 IU/kg every 72 + 6 hours; actual dose determined by Baxter utilizing an algorithm and the patient's pharmacokinetic data). The rates of bleeding episodes for the on-demand regimen and the prophylaxis regimens will also be compared for the cross-over portion of the study. Enrolled patients will be treated originally on demand for a period of 6 months and then they will be randomized into one of the prophylaxis arms. Prophylactic treatment will last for a period of 12 months +/- 2 weeks.


Options:
A: 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
B: Arm Label: 1; Type: ACTIVE_COMPARATOR; Interventions: Drug: Antihemophilic factor, recombinant, manufactured protein-free | Arm Label: 2; Type: EXPERIMENTAL; Interventions: Drug: Antihemophilic factor, recombinant, manufactured protein-free | Intervention Type: DRUG; Name: Antihemophilic factor, recombinant, manufactured protein-free; Assigned to Arm(s): 1 | Intervention Type: DRUG; Name: Antihemophilic factor, recombinant, manufactured protein-free; Assigned to Arm(s): 2
C: 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
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