Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: A Two Part Randomized Cross-Over Trial to Evaluate the Pharmacokinetics, Efficacy, and Safety Profile of Plasma Protein-Free Recombinant FVIII Formulated With Sucrose (BAY81-8973) in Previously Treated Subjects With Severe Hemophilia A Under Prophylaxis Therapy
Brief Summary: The study will assess the pharmacokinetics (part A) safety, tolerability, and efficacy of prophylaxis treatment (2 to 3 times a week) (part B) with BAY81-8973 over a one year period (split into two six month treatment periods). The study will compare 2 different methods (assays) for measuring the amount of study drug, the chromogenic substrate assay per European Pharmacopeia (CS/EP) with the classical assay (Chromogenic Substrate Adjusted, CS/ADJ). During one six month period patients will receive the study drug where the dose has been measured using the" (CS/EP) and during the other six months period the dose will be measured based on the Chromogenic Substrate Adjusted assay CS/ADJ)


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: 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
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: 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

Answer: D