Phase 3
Completed N=115
BAX 326 (rFIX) Continuation Study
Source: ClinicalTrials.gov NCT01286779 ↗Enrolled (actual)
115
Serious AEs
7.8%
Results posted
Sep 2018
Primary outcomePrimary: Adverse Events Possibly or Probably Related to the Investigational Product — 2 Adverse Events
◆ Published Evidence
Emerging
4citations · ~1 / year
Safety, Immunogenicity, and Hemostatic Efficacy of Nonacog Gamma in Patients With Severe or Moderately Severe Hemophilia B: A Continuation Study.
Summary
The purpose of this BAX 326 Continuation Study is to further investigate incremental recovery over time, the hemostatic efficacy, the safety, immunogenicity, and health-related quality of life (HR QoL) of BAX 326 in previously treated patients (PTPs) with severe and moderately severe hemophilia B who participated in BAX 326 pivotal study 250901 or BAX 326 pediatric study 251101.
Linked Publications
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Safety, Immunogenicity, and Hemostatic Efficacy of Nonacog Gamma in Patients With Severe or Moderately Severe Hemophilia B: A Continuation Study.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Adverse Events Possibly or Probably Related to the Investigational Product |
2 | — |
| SECONDARY Treatment of Bleeding Episodes: Number of Infusions Per Bleeding Episode Required Until Bleed Resolution |
1.8; 2.1; 1.9; 1.3; 2.0; 1.5 | — |
| SECONDARY Treatment of Bleeding Episodes: Overall Hemostatic Efficacy Rating at Resolution of Bleed |
341; 168; 51; 0; 219; 122 | — |
| SECONDARY Annualized Bleed Rate During Prophylaxis Treatment |
1.3; 1.4; 1.9; 1.3 | — |
| SECONDARY Consumption of BAX 326: Number of Infusions Per Month and Per Year |
8.5; 10.8; 4.0; 8.4; 3.6; 101.8 | — |
| SECONDARY Consumption of BAX 326: Weight Adjusted Consumption Per Month and Per Year |
462.3; 684.4; 250.9; 464.2; 199.8; 5547.8 | — |
| SECONDARY Consumption of BAX326: Weight Adjusted Consumption Per Bleeding Episode |
124.2; 114.8; 67.4; 122.0; 82.6 | — |
| SECONDARY Development of Inhibitory and Total Binding Antibodies to Factor IX |
0; 0; 0; 0 | — |
| SECONDARY Development of Antibodies to Chinese Hamster Ovary Proteins (CHO Proteins) and rFurin |
0; 0; 4; 4 | — |
| SECONDARY Occurrence of Severe Allergic Reactions and Thrombotic Events |
0; 0 | — |
| SECONDARY Clinical Significant Changes in Routine Laboratory Parameters and Vital Signs |
2; 1; 1; 3; 0 | — |
| SECONDARY Pharmacokinetics: Incremental Recovery (IR) Over Time |
0.85; 0.85; -0.005 | — |
| SECONDARY Pharmacokinetics: Area Under the Plasma Concentration Versus Time Curve From Time 0 to Infinity (AUC 0-∞) |
1335.56 | — |
| SECONDARY Pharmacokinetics: Elimination Phase Half-life (T1/2) |
28.52 | — |
| SECONDARY Pharmacokinetics: Mean Residence Time (MRT) |
29.97 | — |
| SECONDARY Pharmacokinetics: Systemic Clearance (CL) |
0.06 | — |
| SECONDARY Pharmacokinetics: Volume of Distribution at Steady State (Vss) |
1.78 | — |
| SECONDARY Pharmacokinetics: Incremental Recovery (IR) |
0.85 | — |
| SECONDARY Changes in Health Related Quality of Life (HR QoL) Based on Questionnaire SF-36 |
6.7; 3.2; 0.7; 0.8; 4.2; 5.7 | — |
| SECONDARY Changes in Health Related Quality of Life Using the Peds QL |
-2.3; 3.8; 1.6 | — |
| SECONDARY Changes in Health Related Quality of Life (HR QoL) Based on Questionnaire Haemo-QoL and Haem-A-QoL |
-3.0; -0.7 | — |
| SECONDARY Changes in Health Related Quality of Life (HR QoL) Based on Questionnaire EQ-5D and Pain Score. |
0.0; 5.1; -8.0 | — |
Eligibility Criteria
Main Inclusion Criteria:
- Subject and/or legal representative has/have voluntarily provided signed informed consent
- Subject has completed Baxter clinical study 250901 (pivotal study) or Baxter clinical study 251101 (pediatric study)
- Subject was 12 to 65 years old at the time of screening for Study 250901 or 120 kg
- Subject is planned to take part in any other clinical study, with the exception of BAX 326 Surgery study as described in this protocol, during the course of the Continuation Study
Data sourced from ClinicalTrials.gov (NCT01286779) and the linked publication. 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.