N/A
Completed N=6
RIXUBIS Drug Use-Result Survey (Japan)
Source: ClinicalTrials.gov NCT02937831 ↗Enrolled (actual)
6
Serious AEs
0.0%
Results posted
Jul 2024
Primary outcomePrimary: Number of Participants Who Discontinued the Use of Nonacog Gamma (Genetical Recombination) — 1 Participants
Summary
The purpose of this survey is to understand the following items observed in the actual clinical use of RIXUBIS.
1. Unexpected adverse drug reactions
2. Occurrence of adverse drug reactions in the actual clinical use
3. Factors that may affect safety and effectiveness
4. Occurrence of Factor IX (FIX) inhibitor development in patients with coagulation FIX deficiency
5. Safety and effectiveness for hemophilia B patients who received routine prophylactic therapy, on-demand therapy and perioperative therapy
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants Who Discontinued the Use of Nonacog Gamma (Genetical Recombination) |
1 | — |
| PRIMARY Number of Participants Who Developed a Factor IX (FIX) Inhibitor |
— | — |
| PRIMARY Annual Bleed Rate (ABR): Number of Times of Bleeding During the Study |
— | — |
| PRIMARY Number of Doses to Treat A Bleed of Participants on An On-Demand Regimen |
1 | — |
| PRIMARY Hemostatic Effectiveness of Rixubis for Participants on An On-Demand Regimen Based on a 4-Point Ordinal Scale (Excellent, Moderate, Good, Poor) |
1; 0; 0; 0 | — |
| PRIMARY Hemostatic Effectiveness of Rixubis in Surgery-Perioperative and Postoperative Based on a 4-Point Ordinal Scale (Excellent, Moderate, Good, Poor) for Participants Who Received Perioperative Therapy During the Study |
— | — |
| SECONDARY Number of Participants Who Experienced Adverse Events of Shock or Anaphylaxis |
— | — |
| SECONDARY Number of Participants Who Experienced Adverse Events of Thromboembolism |
— | — |
Eligibility Criteria
Inclusion Criteria
- Patients with hemophilia B scheduled to receive treatment with RIXUBIS
Exclusion Criteria
- Patients not administered RIXUBIS
Data sourced from ClinicalTrials.gov (NCT02937831). 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.