BAX 326 Surgery Study in Hemophilia B Patients

This study has been completed.
Sponsor:
Collaborator:
Baxter Innovations GmbH
Information provided by (Responsible Party):
Baxalta US Inc.
ClinicalTrials.gov Identifier:
NCT01507896
First received: January 9, 2012
Last updated: June 26, 2015
Last verified: May 2015

January 9, 2012
June 26, 2015
December 2011
May 2014   (final data collection date for primary outcome measure)
  • Intraoperative hemostatic efficacy [ Time Frame: At completion of surgery ] [ Designated as safety issue: No ]

    Assessment on a 4 point ordinal scale:

    • Excellent
    • Good
    • Fair
  • Actual intraoperative blood loss [ Time Frame: At completion of surgery ] [ Designated as safety issue: No ]
    Actual intraoperative blood loss compared to average and maximum blood loss predicted preoperatively by the operating surgeon
  • Intraoperative hemostatic efficacy [ Time Frame: At completion of surgery ] [ Designated as safety issue: No ]
    Assessment on a scale of "excellent", "good", "fair" and "none"
  • Actual intraoperative blood loss [ Time Frame: At completion of surgery ] [ Designated as safety issue: No ]
    Actual intraoperative blood loss compared to average and maximum blood loss predicted preoperatively by the operating surgeon
Complete list of historical versions of study NCT01507896 on ClinicalTrials.gov Archive Site
  • Postoperative hemostatic efficacy- 72 hours postoperatively [ Time Frame: At time of drain removal, if applicable, or approximately 72 hours postoperatively ] [ Designated as safety issue: No ]

    Assessment on a 4 point ordinal scale:

    • Excellent
    • Good
    • Fair
  • Postoperative Hemostatic Efficacy on Day of Discharge [ Time Frame: From initiation of the surgery until the time of discharge (minor surgery 1-3 days, major surgery average approximately 2 weeks ] [ Designated as safety issue: No ]

    Assessment on a 4 point ordinal scale:

    • Excellent
    • Good
    • Fair
  • Actual postoperative blood loss compared to maximum blood loss [ Time Frame: At time of drain removal, if applicable, or approximately 72 hours postoperatively ] [ Designated as safety issue: No ]
    Actual postoperative blood loss until drain removal, if applicable, compared to maximum blood loss predicted preoperatively by the operating surgeon
  • Daily weight-adjusted dose of BAX326 per participant [ Time Frame: From initiation of the surgery until the time of discharge (minor surgery 1-3 days, major surgery average approximately 2 weeks) ] [ Designated as safety issue: No ]
  • Total weight-adjusted dose of BAX326 per participant [ Time Frame: From initiation of the surgery until the time of discharge (minor surgery 1-3 days, major surgery average approximately 2 weeks) ] [ Designated as safety issue: No ]
  • Number of units of blood product transfused [ Time Frame: From initiation of the surgery until the time of discharge (minor surgery 1-3 days, major surgery average approximately 2 weeks) ] [ Designated as safety issue: No ]
  • Amount of blood product transfused (in mL) [ Time Frame: From initiation of the surgery until the time of discharge (minor surgery 1-3 days, major surgery average approximately 2 weeks) ] [ Designated as safety issue: No ]
  • Development of inhibitory and total binding antibodies to FIX [ Time Frame: 3 years (at study completion) ] [ Designated as safety issue: Yes ]
  • Adverse events related to BAX326 [ Time Frame: 3 years (at study completion) ] [ Designated as safety issue: Yes ]
  • Occurrence of thrombotic events [ Time Frame: 3 years (at study completion) ] [ Designated as safety issue: Yes ]
  • Presurgical Pharmacokinetics (PK): Area under the plasma concentration versus time curve from 0 to 72 hours post-infusion per dose [ Time Frame: 0.5 hour (h) before start of infusion to 72 h ± 2 h following infusion ] [ Designated as safety issue: No ]
  • Presurgical Pharmacokinetics (PK): Total Area under the plasma concentration versus time curve per dose (Total AUC/dose) [ Time Frame: 0.5 hour (h) before start of infusion to 72 h ± 2 h following infusion ] [ Designated as safety issue: No ]
  • Presurgical Pharmacokinetics (PK): Mean residence time (MRT) [ Time Frame: 0.5 hour (h) before start of infusion to 72 h ± 2 h following infusion ] [ Designated as safety issue: No ]
  • Presurgical Pharmacokinetics (PK): Factor IX (FIX) Clearance(CL) [ Time Frame: 0.5 hour (h) before start of infusion to 72 h ± 2 h following infusion ] [ Designated as safety issue: No ]
  • Presurgical Pharmacokinetics (PK): Incremental recovery (IR) [ Time Frame: 0.5 hour (h) before start of infusion, and at 0.5 h ± 5 minutes following infusion. ] [ Designated as safety issue: No ]
  • Presurgical Pharmacokinetics (PK): Elimination phase half-life (T 1/2) [ Time Frame: 0.5 hour (h) before start of infusion to 72 h ± 2 h following infusion ] [ Designated as safety issue: No ]
  • Presurgical Pharmacokinetics (PK): Volume of distribution at steady state (Vss) [ Time Frame: 0.5 hour (h) before start of infusion to 72 h ± 2 h following infusion ] [ Designated as safety issue: No ]
  • Incremental recovery (IR) at 15±5 Minutes Following Loading Dose Prior to Surgery [ Time Frame: Within 60 minutes prior to surgery and 15 ± 5 minutes after loading dose/rebolus, if applicable. ] [ Designated as safety issue: No ]
  • Postoperative hemostatic efficacy [ Time Frame: At time of drain removal, if applicable, or approx. 72 hours postoperatively ] [ Designated as safety issue: No ]
    Assessment on a scale of "excellent", "good", "fair" and "none"
  • Actual postoperative blood loss [ Time Frame: At time of drain removal, if applicable, or approx. 72 hours postoperatively ] [ Designated as safety issue: No ]
    Actual postoperative blood loss until drain removal, if applicable, compared to average and maximum blood loss predicted preoperatively by the operating surgeon
  • Development of inhibitory and total binding antibodies to FIX [ Time Frame: 3 years (at study completion) ] [ Designated as safety issue: Yes ]
  • Adverse events related to BAX326 [ Time Frame: 3 years (at study completion) ] [ Designated as safety issue: Yes ]
  • Occurrence of thrombotic events [ Time Frame: 3 years (at study completion) ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
 
BAX 326 Surgery Study in Hemophilia B Patients
BAX 326 (Recombinant Factor IX): A Phase 3 Prospective, Multicenter Study Evaluating Efficacy and Safety in Previously Treated Patients With Severe (FIX Level < 1%) or Moderately Severe (FIX Level 1-2%) Hemophilia B Undergoing Surgical or Other Invasive Procedures
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.
Not Provided
Interventional
Phase 3
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Hemophilia B
Biological: Recombinant factor IX
Following a loading dose with BAX326, participants will receive BAX326 as a bolus infusion. The treatment regimen will be determined by the intensity and duration of the hemostatic challenge and the institution´s standard of care. The dose will be tailored to raise FIX concentration to at least 80%-100% of normal for major surgeries and to at least 30%-60% of normal for minor surgeries.
Other Names:
  • BAX326
  • RIXUBIS
Experimental: BAX326 in Surgery
Intervention: Biological: Recombinant factor IX
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
41
May 2014
May 2014   (final data collection date for primary outcome measure)

Main Inclusion Criteria:

  • Participant and/or legal representative has/have voluntarily provided signed informed consent.
  • Participant has severe (FIX level < 1%) or moderately severe (FIX level 1-2%) hemophilia B (based on the one stage activated partial thromboplastin time (aPTT) assay), as tested at screening at the central laboratory.
  • Participant requires surgery
  • Participant has previously been treated with plasma-derived and/or recombinant FIX concentrate(s) for a minimum of 150 exposure days
  • Participant has no evidence of a history of FIX inhibitors
  • Participant is immunocompetent as evidenced by a CD4 count ≥ 200 cells/mm3.
  • Participant is human immunodeficiency (HIV) negative or is HIV+ with a viral load < 200 particles/μL ~ < 400,000 copies/mL.

Main Exclusion Criteria:

  • Participant has a history of FIX inhibitors with a titer ≥ 0.6 Bethesda Units (BU) (as determined by the Nijmegen modification of the Bethesda assay or the assay employed in the respective local laboratory) at any time prior to screening.
  • Participant has a detectable FIX inhibitor at screening, with a titer ≥0.6 Bethesda Units (BU) as determined by the Nijmegen modification of the Bethesda assay in the central laboratory.
  • Participant has a history of allergic reaction or evidence of an ongoing or recent thrombotic disease, fibrinolysis or disseminated intravascular coagulation (DIC).
  • Known hypersensitivity to hamster proteins or recombinant furin.
  • Evidence of an ongoing or recent thrombotic disease, fibrinolysis or disseminated intravascular coagulation (DIC).
  • Abnormal renal function
  • Severe chronic liver disease
  • Active hepatic disease with ALT or AST levels > 5 times the upper limit of normal.
  • Diagnosis of an iherited or acquired hemostatic defect other than hemophilia B.
  • Platelet count < 100,000/mL.
Both
12 Years to 65 Years   (Child, Adult)
No
Contact information is only displayed when the study is recruiting subjects
Argentina,   Bulgaria,   Chile,   Colombia,   Czech Republic,   Poland,   Romania,   Russian Federation,   Ukraine,   United Kingdom
Brazil,   Japan,   Sweden
 
NCT01507896
251002, 2011-000413-39
Yes
Not Provided
Not Provided
Baxalta US Inc.
Baxalta US Inc.
Baxter Innovations GmbH
Study Director: Eva-Maria Poellabauer, MD Baxter Innovations GmbH
Baxalta US Inc.
May 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP