RIXUBIS PMS India (RIXUBIS PMS)
Condition: Hemophilia B
MeSH terms: Hemophilia A; Hemophilia B
Intervention: RIXUBIS: On-Demand; RIXUBIS: Prophylaxis
Intervention description: RIXUBIS used under standard clinical practice in India: On-Demand treatment.; RIXUBIS used under standard clinical practice in India: Prophylaxis treatment.
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 25.0
Sex: All
Healthy volunteers: No

Summary:

      The purpose of this study is to characterize the safety and describe the effectiveness of
      RIXUBIS in routine clinical practice.
    

Eligibility criteria:

        Inclusion Criteria

          1. The participant or legally authorized representative (in case of study participants
             <18 years of age) gave written informed consent to participate in the study.

          2. Participant has hemophilia B.

          3. Participant is defined as previously-treated patient (PTP):

               -  Participant aged ≥ 6 years that has been previously treated with plasma-derived
                  and/or recombinant factor IX (FIX) concentrate(s) for a minimum of 150 exposure
                  days (EDs).

               -  Participant aged < 6 years that has been previously treated with plasma-derived
                  and/or recombinant FIX concentrate(s) for a minimum of 50 EDs.

          4. Participant has no evidence of a history of FIX inhibitors.

          5. Participant is human immunodeficiency virus negative (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 or PCR testing (if
             positive, antibody titer will be confirmed by polymerase chain reaction (PCR)), as
             confirmed by central laboratory at screening; or HCV+ with chronic stable hepatitis.

          7. The participant is willing and able to comply with the requirements of the protocol.

        Exclusion Criteria

          1. Participant has known hypersensitivity or presence of any contraindication to RIXUBIS
             or its excipients including hamster protein.

          2. Participant has evidence of an ongoing or recent thrombotic disease, fibrinolysis or
             disseminated intravascular coagulation (DIC).

          3. Participant has a history of FIX inhibitors with a titer ≥ 0.6 Bethesda Units (BU) (as
             determined by the Nijmegen modification of the Bethesda assay or the assay, employed
             in the respective local laboratory) at any time prior to screening.

          4. Participant has a detectable FIX inhibitor at screening, with a titer ≥ 0.6 BU as
             determined by the Nijmegen modification of the Bethesda assay in the central
             laboratory.

          5. Participant 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.

          6. Participant has severe chronic hepatic dysfunction [eg, ≥ 5 times upper limit of
             normal alanine aminotransferase (ALT), as confirmed by central laboratory at
             screening, or a documented INR > 1.5].

          7. Participant has severe renal impairment (serum creatinine > 2.0 mg/dL), as confirmed
             by central laboratory at screening.

          8. Participant has been diagnosed with an inherited or acquired hemostatic defect other
             than hemophilia B.

          9. Participant's platelet count is < 100,000/mL.

         10. 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.

         11. Participant is currently receiving, or is scheduled to receive during the course of
             the study, an immunomodulating drug (eg, corticosteroid agents at a dose equivalent to
             hydrocortisone greater than 10 mg/day, or α-interferon) other than antiretroviral
             chemotherapy.

         12. Participant has participated in another clinical study involving an investigational
             product (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.

         13. Participant is a family member or employee of the investigator.