Health Condition 1: null- Previously treated patients (PTPs) with severe (FIX level 1%) or moderately severe (FIX level â?¤ 2%) hemophilia B
Conditions
Interventions
Intervention1: _ Standard Prophylactic treatment: twice weekly: Modified Prophylactic treatment:As determined by the investigator.Subjects will undergo a pharmacokinetic evaluation with recombinant F
Sponsors
Baxter Innovation GmBH
Eligibility
Inclusion criteria
Inclusion criteria: Modified Prophylactic treatment:As determined by the investigator.Subjects will undergo a pharmacokinetic evaluation with recombinant Factor IX before starting the prophylactic treatment,or _On-demand treatment: Dose for on-demand treatment depends on the severity of the bleed.
Exclusion criteria
Exclusion criteria: Exclusion criteria: • The subject received factor IX product(s) other than BAX326 upon completion of Baxter Pivotal Study 250901 or Pediatric Study 251101. • The subject has been diagnosed with an acquired hemostatic defect other than hemophilia B. • For subjects transferring from Pivotal Study 250901: The subjectâ??s weight is 35 kg or 120 kg. • The subjectâ??s platelet count is 100,000/mL. • The subject has an abnormal renal function (serum creatinine 1.5 times the upper limit of normal). • The subject has active hepatic disease with alanine aminotransferase (ALT) or aspartate aminotransferase (AST) levels >= 5 times the upper limit of normal. • The subject is scheduled to receive during the course of the study, an 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. • The subject has a clinically significant medical, psychiatric, or cognitive illness, or recreational drug/alcohol use that, in the opinion of the investigator, would affect subjectâ??s safety or compliance. • The subject is planned to take part in any other clinical study, with the exception of BAX326 Surgery Study as described in this protocol, during the course of the Continuation Study. • The subject 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 (i.e., children, partner/spouse, siblings, parents) as well as employees of the investigator or site personnel conducting the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| All AEs possibly or probably related to BAX326Timepoint: 8 months | — |
Secondary
| Measure | Time frame |
|---|---|
| ï?§ Safety and Immunogenicity ï?§ PK â?¢ Incremental recovery over time ï?§ Hemostatic efficacy ï?§ Health Related Quality of Life and Pharmacoeconomic Parameters Timepoint: 8 months | — |
Countries
Argentina, Brazil, Bulgaria, Chile, Colombia, Czech Republic, India, Japan, Poland, Romania, Sweden, United Kingdom
Contacts
Public ContactSharad Jain
Baxter (India) Pvt. Ltd.
Outcome results
None listed