Please select the eligibility criteria that correspond to the clinical trial below.
Title: An Open-label, Multicenter Evaluation of Safety, Pharmacokinetics and Efficacy of Recombinant Coagulation Factor IX Fc Fusion Protein, BIIB029, in the Prevention and Treatment of Bleeding Episodes in Pediatric Subjects With Hemophilia B
Brief Summary: The primary objective of the study is to evaluate the safety of Recombinant Human Coagulation Factor IX Fc Fusion Protein (rFIXFc) in previously treated pediatric subjects with hemophilia B. Secondary objectives of this study in this study population are as follows: to evaluate the efficacy of rFIXFc for prevention and treatment of bleeding episodes; to evaluate and assess the pharmacokinetics (PK) of rFIXFc; to evaluate rFIXFc consumption for prevention and treatment of bleeding episodes


Options:
A: INCLUSION CRITERIA:

* Participants transitioning from another BAX 855 study who meet ALL of the following criteria are eligible for this study:

  1. Participant has completed the end of study visit of a BAX 855 study or is transitioning from the ongoing Baxalta Continuation Study 261302.
  2. Participant is either receiving on-demand treatment or prophylactic treatment with BAX 855 and had an Annual Bleed Rate (ABR) of ≥ 2 documented and treated during the past 12 months.
  3. Participant is human immunodeficiency virus negative (HIV-); or HIV+ with stable disease and CD4+ count ≥ 200 cells/mm\^3, as confirmed by central laboratory.
  4. Participant is willing and able to comply with the requirements of the protocol.
* Newly recruited participants (ie not transitioning from another BAX 855 study) including BAX855 naïve participants who meet ALL of the following criteria are eligible for this study:

  1. Participant has severe hemophilia A (FVIII clotting activity \< 1%) as confirmed by central laboratory OR by historically documented FVIII clotting activity performed by a certified clinical laboratory, optionally supported by a FVIII gene mutation consistent with severe hemophilia A
  2. Participant has been previously treated with plasma-derived FVIII concentrates or recombinant FVIII for ≥ 150 documented exposure days (EDs)
  3. Participant is either receiving on-demand treatment or prophylactic treatment and had an annual bleeding rate of ≥ 2 documented and treated during the past 12 months.
  4. Participant has a Karnofsky performance score of ≥ 60 at screening
  5. Participant is HIV-; or HIV+ with stable disease and CD4+ count ≥ 200 cells/mm\^3, as confirmed by central laboratory at screening
  6. Participant is hepatitis C virus negative (HCV-) by antibody (if positive, additional PCR testing will be performed), as confirmed by central laboratory at screening; or HCV+ with chronic stable hepatitis
  7. If female of childbearing potential, participant presents with a negative urine pregnancy test and agrees to employ adequate birth control measures for the duration of the study
  8. Participant is willing and able to comply with the requirements of the protocol.

EXCLUSION CRITERIA:

* Participants transitioning from another BAX 855 study who meet ANY of the following criteria are not eligible for this study:

  1. Participant has developed a confirmed inhibitory antibody to FVIII with a titer of ≥ 0.6 BU using the Nijmegen modification of the Bethesda assay as determined at the central laboratory during the course of the previous BAX 855 study.
  2. Participant has been diagnosed with an acquired hemostatic defect other than hemophilia A.
  3. The participant's weight is \< 35 kg or \> 100 kg.
  4. Participant's platelet count is \< 100,000/mL.
  5. Participant has an abnormal renal function (serum creatinine \> 1.5 times the upper limit of normal).
  6. Participant has active hepatic disease with alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) levels ≥ 5 times the upper limit of normal.
  7. Participant is scheduled to receive a systemic immunomodulating drug (e.g. corticosteroid agents at a dose equivalent to hydrocortisone greater than 10 mg/day, or α-interferon) other than anti-retroviral chemotherapy during the study.
  8. Participant has a clinically significant medical, psychiatric, or cognitive illness, or recreational drug/alcohol use that, in the opinion of the investigator, would affect participant's safety or compliance.
  9. Participant is planning to take part in any other clinical study during the course of the study.
  10. Participant is a member of the team conducting this study or is in a dependent relationship with one of the study team members. Dependent relationships include close relatives (ie, children, partner/spouse, siblings, parents) as well as employees of the investigator or site personnel conducting the study.

Newly recruited participants (ie not transitioning from another BAX 855 study) who meet ANY of the following criteria are not eligible for this study:

1. Participant has detectable FVIII inhibitory antibodies (≥ 0.6 BU using the Nijmegen modification of the Bethesda assay) as confirmed by central laboratory at screening.
2. Participant has a history of confirmed FVIII inhibitors with a titer ≥ 0.6 Bethesda Units (BU) (as determined by the Nijmegen modification of the Bethesda assay or the assay employed with the respective cut-off in the local laboratory) at any time prior to screening.
3. Participant has been diagnosed with an inherited or acquired hemostatic defect other than hemophilia A (eg, qualitative platelet defect or von Willebrand's disease).
4. The participant's weight is \< 35 kg or \> 100 kg.
5. Participant's platelet count is \< 100,000/mL.
6. Participant has known hypersensitivity towards mouse or hamster proteins, PEG or Tween 80.
7. Participant has severe chronic hepatic dysfunction \[eg, ≥ 5 times upper limit of normal alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST), as confirmed by central laboratory at screening, or a documented INR \> 1.5\].
8. Participant has severe renal impairment (serum creatinine \> 1.5 times the upper limit of normal).
9. Participant has current or recent (\< 30 days) use of other pegylated drugs prior to study participation or is scheduled to use such drugs during study participation.
10. Participant is scheduled to receive during the course of the study, a systemic immunomodulating drug (e.g. corticosteroid agents at a dose equivalent to hydrocortisone greater than 10 mg/day, or α-interferon) other than anti-retroviral chemotherapy.
11. Participant has participated in another clinical study involving an IP or investigational device within 30 days prior to enrollment or is scheduled to participate in another clinical study involving an IP or investigational device during the course of this study.
12. Participant has a medical, psychiatric, or cognitive illness or recreational drug/alcohol use that, in the opinion of the investigator, would affect participant safety or compliance.
13. Participant is a member of the team conducting this study or is in a dependent relationship with one of the study team members. Dependent relationships include close relatives (ie, children, partner/spouse, siblings, parents) as well as employees of the investigator or site personnel conducting the study.
B: 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.
C: Key Inclusion Criteria:

* Severe hemophilia B defined as ≤ 2 IU/dl (≤ 2%) endogenous FIX
* Male \< 12 years and weight ≥ 13 kg
* History of at least 50 documented prior exposure days to FIX
* No history of, or currently detectable, inhibitor

Key Exclusion Criteria:

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

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

* Subjects who have completed previous rFVIIIFc studies (NCT01181128, NCT02083965, NCT01458106 and NCT02502149)
* Ability to understand purposes and risks of the study and to provide signed and dated informed consent (or assent, as applicable).

Key Exclusion Criteria:

* Confirmed positive high-titer inhibitor (≥5.00 BU/mL).

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply

Answer: C