Male subjects, aged 6 years to 65 years, with a documented history of moderately severe or severe Hemophilia B (FIX:C=2%) and with a minimum of 12 bleeding episodes, of which 6 must be joint bleeds, in the 12 months before screening. MedDRA version: 8.1 Level: LLT Classification code 10060614 Term: Hemophilia B (Factor IX)
Conditions
Interventions
Trade Name: BeneFIX
Pharmaceutical Form: Powder and solvent for solution for injection
INN or Proposed INN: NONACOG ALFA
CAS Number: 181054955
Current Sponsor code: 3090A1
Other descriptive name: Reco
Sponsors
Wyeth Pharmaceuticals Inc. - Global Medical Affairs
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1. Documented history of moderately severe or severe hemophilia B (FIX:C = 2%) 2. Male subjects, aged 6 years to 65 years. 3. Subjects with a minimum of 12 bleeding episodes, 6 of which must be joint bleeds, in the 12 months before screening. 4. Written informed consent or assent, as applicable. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Subjects currently utilizing FIX primary prophylaxis 2. For documented HIV+ subjects, CD4 count 5xULN, bilirubin > 2mg/dL, serum albumin 1.25xULN) 4. Prothrombin time > 1.5xULN 5. Platelet count ULN of the reporting laboratory 9. Subjects with a known hypersensitivity to any FIX product or hamster protein 10. Exposure to any investigational drug, except for BeneFIX, or device within 30 days of providing consent/assent (as appropriate) for this study 11. Subjects with bleeding disorders other than hemophilia B 12. Documented concurrent inflammatory disease that in the investigator's judgment could confound the study results (eg: systemic lupus, rheumatoid arthritis or inflammatory bowel disease) 13. Subjects unwilling to adhere to the terms of this protocol 14. Subjects with poor venous access, or who are otherwise inappropriate candidates for this trial in the judgment of the investigator. 15. Subjects committed to an institution by virtue of an order issued by the courts or by a public authority.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the efficacy and safety of BeneFIX infused as prophylaxis regimens, compared with BeneFIX administered in an on-demand regimen only.;Secondary Objective: To evaluate and compare the efficacy, safety, and subject-reported outcomes of 2 BeneFIX prophylaxis regimens (100 IU/kg once weekly vs. 50 IU/kg twice weekly), as well as subject-reported outcomes between the prophylaxis regimen and the first on-demand regimen.;Primary end point(s): Primary Endpoint: 1. Annualized number of bleeding episodes Secondary end points: 2. Amount and quality of sleep after hemarthrosis (Sleep Diary) 3. Acute pain scale after hemarthrosis (Brief Pain Inventory) 4. Days lost from work or school after hemarthrosis (Health-related Productivity Questionnaire) 5. Physical functioning domain SF 36 Questionnaire | — |
Countries
Germany, Hungary, Italy
Outcome results
None listed