Phase 3
Completed N=35
Study Evaluating On-Demand Treatment With BeneFIX In Chinese Subjects
Source: ClinicalTrials.gov NCT00866606 ↗Enrolled (actual)
35
Serious AEs
5.7%
Results posted
Jan 2011
Primary outcomePrimary: Investigator Hemostatic Efficacy Assessment of Participants After 8 Hours Post Infusion — 1.70 Units on a scale
Summary
This study will evaluate the safety and efficacy of on-demand treatment with BeneFIX in Chinese hemophilia B subjects.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Investigator Hemostatic Efficacy Assessment of Participants After 8 Hours Post Infusion |
1.70 | — |
| PRIMARY Investigator Hemostatic Efficacy Assessment of Participants After 24 Hours Post Infusion |
1.58 | — |
| PRIMARY Percentage of Participants With FIX Inhibitor Development |
2.86; 4.17; 0 | — |
| SECONDARY Number of Infusions Required to Treat Each Bleed |
1.20 | — |
| SECONDARY FIX Incremental Recovery |
0.760; 0.727 | — |
| SECONDARY Percentage of Participants With Less Than Expected Therapeutic Effect (LETE) |
— | — |
| SECONDARY Percentage of Participants With Allergic-Type Allergic Reactions |
— | — |
| SECONDARY Percentage of Participants With Thrombosis |
— | — |
| SECONDARY Percentage of Participants With Red Blood Cell (RBC) Agglutination |
— | — |
Eligibility Criteria
Inclusion Criteria
- Subjects equal or more than 6 years of age with mild, moderate or severe hemophilia B (FIX activity: more than 5%, 1-5%, or less than 1%, respectively)
- Subjects with previous exposure to FIX replacement therapy
- If HIV positive, documented CD4 count more than 200/µL within 6 months of study entry
Exclusion Criteria
- Diagnosed with any bleeding disorder in addition to hemophilia B
- Current FIX inhibitor or history of FIX inhibitor (defined as >ULN of the reporting laboratory)
- Subject has no history of exposure to FIX products (previously untreated patient [PUP])
- Subject is currently utilizing primary FIX prophylaxis
- Subjects anticipating elective surgery that may be planned to occur in the 6 months following study entry
- Treated with immunomodulatory therapy within 30 days prior to study entry or planned use for the duration of their study participation
- Participated in another investigational drug or device study within 30 days prior to study entry or planned participation for the duration of their study participation
- Subjects with a known hypersensitivity to hamster protein
- Significant hepatic or renal impairment (ALT and AST >5 x ULN, bilirubin >2 mg/dL or serum creatinine >1.25 x ULN)
- Prothrombin Time >1.5 x ULN
- Platelet count <80,000/µL
- Pregnant or breastfeeding women
- Unwilling or unable to follow the terms of the protocol
- Any condition which may compromise the subject's ability to comply with and/or perform study-related activities or that poses a clinical contraindication to study participation, in the opinion of the Investigator or Sponsor
Data sourced from ClinicalTrials.gov (NCT00866606). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.