Please select the eligibility criteria that correspond to the clinical trial below.
Title: Observational Study Evaluating Efficacy and Costs of Secondary Prophylaxis vs On-demand Therapy With Kogenate Bayer in Patients With Severe Haemophilia A. POTTER
Brief Summary: The project is a controlled observational, multicenter, prospective data collection on secondary prophylaxis with Kogenate Bayer in adolescents and adults with severe haemophilia A (FVIII \< 1%).

The observational period will cover at least 5 years per patient.

The long-term secondary prophylaxis group will be compared versus on-demand treatment group by the assessment of orthopedic status progression and pharmacoeconomics evaluation.


Options:
A: Inclusion Criteria:

* age ≥ 12 years and ≤ 55 years
* severe haemophilia A (FVIII \< 1%)
* absence of inhibitors (Bethesda titre \< 0.6 BU/ml)
* Previous Treated Patients (prior exposure days \> 200)
* Kogenate Bayer administered 20-30 IU/kg -3 times a week, for the prophylaxis group
* ≥ 6 joint bleeds requiring treatment with FVIII concentrates in the previous 6 months before enrollment, for on-demand group
* written informed consent

Exclusion Criteria:

* concomitant severe and chronic diseases or congenital skeletal malformation
* unreliability of patient or likelihood of follow-up failure
* presence of inhibitors or history of inhibitors (in the previous 2 years)
* currently on immune tolerance treatment
* hepatic cirrhosis or liver disease in rapid progression
* AIDS
* platelet count \< 75,000/mm3
* presence of conditions that influence negatively patient´s compliance
* participation in another study
B: Inclusion Criteria: - Informed consent obtained before any trial related activities. Trial related activities are any procedures that are carried out as part of the trial, including activities to determine the suitability for the trial - Male haemophilia A or B patients with inhibitors aged 18 years or older at the time of signing informed consent - Patients currently in need of treatment with bypassing agents Exclusion Criteria: - Known or suspected hypersensitivity to trial product(s) or related products - Known inherited or acquired bleeding disorder other than haemophilia - Ongoing or planned immune tolerance induction therapy or prophylaxis with FVIII or FIX
C: Key Inclusion Criteria:

* Severe hemophilia A defined as \<1 IU/dL (\<1%) endogenous FVIII
* Male \<12 years of age and weight ≥13 kg
* History of at least 50 documented prior exposure days to FVIII
* No current, or history of, inhibitor development to FVIII

Key Exclusion Criteria:

* Other coagulation disorders in addition to Hemophilia A
* History of anaphylaxis associated with any FVIII or IV immunoglobulin administration

NOTE: Other protocol-defined Inclusion/Exclusion criteria may apply.
D: Inclusion Criteria:

* Male subjects diagnosed with haemophilia A without inhibitors present at screening and currently treated on-demand
* Subjects with a baseline level of factor VIII below or equal to 2 % based on medical records
* Age between 18 and 64 years both inclusive, at the time of signing informed consent
* Body weight between 50 and 100 kg, both inclusive

Exclusion Criteria:

* Known or suspected hypersensitivity to trial product or related products
* Platelet count below 50x10\^9/L at screening
* Any clinical signs or known history of thromboembolic events, or subjects considered at high risk of thromboembolic events as judged by the investigator
* Subjects at increased risk of cardiovascular disease as judged by the investigator

Answer: A