Phase 3
Completed N=30
BAX 326 Surgery Study in Hemophilia B Patients
Source: ClinicalTrials.gov NCT01507896 ↗Enrolled (actual)
30
Serious AEs
0.0%
Results posted
Feb 2017
Primary outcomePrimary: Intraoperative Hemostatic Efficacy — 37; 20; 17; 1 surgeries
◆ Published Evidence
Established
26citations · ~2 / year
Efficacy and safety of a recombinant factor IX (Bax326) in previously treated patients with severe or moderately severe haemophilia B undergoing surgical or other invasive procedures: a prospective, open-label, uncontrolled, multicentre, phase III study.
Summary
The purpose of the study is to assess the hemostatic efficacy and safety of BAX 326 in subjects with severe (FIX level < 1%) or moderately severe (FIX level 1-2%) hemophilia B undergoing major or minor elective or emergency surgical, dental or other invasive procedures.
Linked Publications (2)
-
Efficacy and safety of a recombinant factor IX (Bax326) in previously treated patients with severe or moderately severe haemophilia B undergoing surgical or other invasive procedures: a prospective, open-label, uncontrolled, multicentre, phase III study.
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Phase 3 Clinical Trial: Perioperative Use of Nonacog Gamma, a Recombinant Factor IX, in Previously Treated Patients With Moderate/Severe Hemophilia B.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Intraoperative Hemostatic Efficacy |
37; 20; 17; 1; 1; 0 | — |
| PRIMARY Actual Intraoperative Blood Loss |
191.1; 344.9; 1.2 | — |
| PRIMARY Actual Intraoperative Blood Loss Compared to Average and Maximum Blood Loss Predicted Preoperatively by the Operating Surgeon |
-27.0; -50.9; 2.4; 128.3; 222.0; 12.5 | — |
| PRIMARY Postoperative Hemostatic Efficacy at Drain Removal |
10; 4; 0; 0 | — |
| PRIMARY Postoperative Hemostatic Efficacy at Postoperative Day 3 |
7; 6; 1; 1; 1; 0 | — |
| PRIMARY Postoperative Hemostatic Efficacy on Day of Discharge |
29; 12; 17; 7; 7; 0 | — |
| PRIMARY Actual Postoperative Blood Loss |
603.6 | — |
| PRIMARY Actual Postoperative Blood Loss Compared to Average and Maximum Blood Loss Predicated Preoperatively by the Operating Surgeon |
-221.4; 147.1 | — |
| PRIMARY Daily Weight-Adjusted Dose of BAX326 Per Participant |
144.8; 191.5; 87.2; 103.9; 136.7; 63.5 | — |
| PRIMARY Total Weight-Adjusted Dose of BAX326 Per Participant |
145; 191; 87; 808; 1350; 138 | — |
| PRIMARY Number of Units of Blood Product Transfused |
2.8; 1.5 | — |
| PRIMARY Volume of Blood Product Transfused |
834.3; 414.0 | — |
| PRIMARY Safety: Number of Participants Who Developed Inhibitory Antibodies to Factor IX (FIX) |
— | — |
| PRIMARY Safety: Number of Participants Who Developed Total Binding Antibodies to Factor IX (FIX) |
— | — |
| PRIMARY Safety: Number of Adverse Events Related to BAX326 |
1 | — |
| PRIMARY Safety: Occurence of a Thrombotic Event |
— | — |
| PRIMARY Pre-Surgical Pharmacokinetics (PK): Area Under the Plasma Concentration Versus Time Curve (AUC) From 0 to 72 Hours Post-infusion Per Dose |
18.48 | — |
| PRIMARY Pre-Surgical Pharmacokinetics (PK): Total Area Under the Plasma Concentration Versus Time Curve Per Dose (Total AUC/Dose) |
20.60 | — |
| PRIMARY Pre-Surgical Pharmacokinetics (PK): Mean Residence Time (MRT) |
27.17 | — |
| PRIMARY Pre-Surgical Pharmacokinetics (PK): Factor IX (FIX) Clearance (CL) |
0.0523 | — |
| PRIMARY Pre-Surgical Pharmacokinetics (PK): Incremental Recovery (IR) at 30 Min |
1.00 | — |
| PRIMARY Pre-Surgical Pharmacokinetics (PK): Elimination Phase Half-life (T 1/2) |
23.60 | — |
| PRIMARY Pre-Surgical Pharmacokinetics (PK): Volume of Distribution at Steady State (Vss) |
1.41 | — |
| PRIMARY Incremental Recovery (IR) at 15±5 Minutes Following Loading Dose Prior to Surgery |
0.910 | — |
Eligibility Criteria
Main Inclusion Criteria:
- Participant and/or legal representative has/have voluntarily provided signed informed consent.
- Participant has severe (FIX level 5 times the upper limit of normal.
- Diagnosis of an iherited or acquired hemostatic defect other than hemophilia B.
- Platelet count < 100,000/mL.
Data sourced from ClinicalTrials.gov (NCT01507896) 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.