Phase 3 N=30 Treatment

BAX 326 Surgery Study in Hemophilia B Patients

Hemophilia B

Bottom Line

View on ClinicalTrials.gov: NCT01507896 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Feb 2017

Primary outcome: Primary: Intraoperative Hemostatic Efficacy — 37; 20; 17; 1 surgeries

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: Recombinant factor IX (Biological)
Age: Pediatric, Adult, Older Adult · 12+ yrs
Sex: All
Sponsor: Baxalta now part of Shire
Primary completion: May 2014

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	—

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.

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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01507896). 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.