Please select the eligibility criteria that correspond 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: Inclusion Criteria:

* Males, age 18 to 65 years.
* Subjects with Severe Hemophilia A with a documented plasma FVIII level of \< 1%
* ≥ 150 exposure days with FVIII concentrate(s) as supported by medical records

Exclusion Criteria:

* Evidence of current or past inhibitor antibody:
* History of any congenital or acquired coagulation disorders other than hemophilia A.
* Platelet count \<75,000/mm\*3.
* Abnormal renal function (serum creatinine \>2 x the upper limit of the normal range).
* Active liver disease verified by medical history or persistently elevated alanine aminotransferase or aspartate aminotransferase \>5 x the upper limit of the normal range or severe liver disease as evidenced by, but not limited to any of the following: International Normalized Ratio \>1.4, hypoalbuminemia, portal vein hypertension including presence of otherwise unexplained splenomegaly and history of esophageal varices.
B: Inclusion Criteria:

* The subject has severe or moderately severe hemophilia A as defined by a baseline factor VIII level \<= 2% of normal, as tested at screening
* The subject has a documented history of at least 150 exposure days to factor VIII concentrates (either plasma-derived or recombinant)
* The subject is within 7 to 65 years of age
* The subject has a Karnofsky performance score \> (greater than) 60
* The subject is human immunodeficiency virus negative (HIV-) or is HIV+ with a CD4 count \>= 400 cells/mm³ (CD4 count determined at screening, if necessary)
* The subject has been on a documented on-demand treatment regimen for at least 12 months immediately prior to enrollment
* The subject has a documented history (e.g. in medical charts or dispensing information, or signed investigator statement) of at least 8 joint hemorrhages in the 12 months immediately prior to enrollment
* The subject resides within the coverage area of the mobile compliance device; coverage area will be determined at screening
* The subject or the subject's legally authorized representative has provided written informed consent

Exclusion Criteria:

* The subject has a known hypersensitivity to factor VIII concentrates or mouse or hamster proteins
* The subject has a history of factor VIII inhibitors with a titer \>= 0.6 BU (by Bethesda or Nijmegen assay) at any time prior to screening
* The subject has a detectable factor VIII inhibitor at screening, with a titer \>= 0.4 BU (by Nijmegen Assay) in the central laboratory
* The subject has severe chronic liver disease as evidenced by, but not limited to, any of the following: International Normalized Ratio (INR) \> 1.4, hypoalbuminemia, portal vein hypertension including presence of otherwise unexplained splenomegaly and history of esophageal varices.
* The subject has been diagnosed with an inherited or acquired hemostatic defect other than hemophilia A (e.g., qualitative platelet defect or von Willebrand's Disease)
* The subject has been treated during the last sixty (60) days prior to or is being treated at screening/enrollment with an immunomodulating drug.
* The subject has participated in another investigational study within thirty (30) days of enrollment
* The subject has previously participated in a clinical study with rAHF-PFM
* The subject's clinical condition may require a major surgery (defined as moderate to critical risk and perioperative blood loss ≥ 500 mL) during the period of the subject's participation in the study
* The subject is female of childbearing potential with a positive pregnancy test
C: Inclusion Criteria:

* Male, aged 12 to 65 years
* Severe hemophilia A
* History of more than 150 exposure days (ED) with clotting factor concentrates
* Currently receiving episodic treatment with FVIII; no regular prophylaxis for more than 6 consecutive months in the past 5 years
* No current Factor VIII inhibitor or history of inhibitor
* Willing to use electronic patient diary

Exclusion Criteria:

* Presence of another bleeding disease that is different from hemophilia A
* Thrombocytopenia
* Abnormal renal function
* Presence of active liver disease
* Known hypersensitivity to FVIII
D: Inclusion Criteria:

* Documented history of moderately severe or severe hemophilia B (FIX:C less than or equal to 2%)
* Male subjects, aged 6 years to 65 years.
* Subjects with a minimum of 12 bleeding episodes, 6 of which must be joint bleeds, in the 12 months before screening.

Exclusion Criteria:

* Subjects currently utilizing FIX primary prophylaxis.
* Subjects with HIV+ who have a CD4 count less than 200
* Subjects with hepatic or renal impairment.
* Prothrombin time or International Normalized Ration more than 1.5 times the upper limit of normal.
* Major surgery or an orthopedic surgical procedure within the past 3 months or is planned within the duration of participation in this study.
* Past history of, or current FIX inhibitor.
* Hypersensitivity to any FIX product or hamster protein.
* Exposure to any investigational drug, except for rFIX-R, or device within 30 days of providing consent/assent (as appropriate) for this study.
* Bleeding disorders other than hemophilia B.
* Concurrent inflammatory disease that in the investigator's judgment could confound the study results.

Answer: B