BAX 326 Surgery Study

This study has been completed.
Sponsor:
Collaborator:
Baxter Innovations GmbH
Information provided by (Responsible Party):
Baxter Healthcare Corporation
ClinicalTrials.gov Identifier:
NCT01507896
First received: January 9, 2012
Last updated: May 28, 2014
Last verified: May 2014
  Purpose

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 ≤ 2%) hemophilia B undergoing major or minor elective or emergency surgical, dental or other invasive procedures.


Condition Intervention Phase
Hemophilia B
Biological: Recombinant factor IX
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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 ≤ 2%) Hemophilia B Undergoing Surgical or Other Invasive Procedures

Resource links provided by NLM:


Further study details as provided by Baxter Healthcare Corporation:

Primary Outcome Measures:
  • Intraoperative hemostatic efficacy [ Time Frame: At completion of surgery ] [ Designated as safety issue: No ]

    Assessment on a 4 point ordinal scale:

    • Excellent
    • Good
    • Fair
    • 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


Secondary Outcome Measures:
  • 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
    • None

  • 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
    • None

  • 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 ]

Enrollment: 41
Study Start Date: December 2011
Study Completion Date: May 2014
Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: BAX326 in Surgery 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 80%-100% of normal for major surgeries and to 30%-60% of normal for minor surgeries.
Other Names:
  • BAX326
  • RIXUBIS

  Eligibility

Ages Eligible for Study:   12 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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 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).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01507896

Locations
Argentina
Instituto de Hematología y Medicina Clínica Rubén Dávoli
Rosario, Argentina, 2000
Bulgaria
Specialized Haematological Hospital "Joan Pavel"
Sofia, Bulgaria, 1233
Chile
Hospital Dr. Sotero del Rio
Santiago, Chile
Colombia
Centro Medico Imbanaco
Cali, Colombia
Czech Republic
Klinika detska hematologie a onkologie
Prague, Czech Republic, 150 06
Poland
Medical University Hospital - University Clinic Centre, Hematology and Transplantology Clinic
Gdansk, Poland, 80-952
Medical University Lodz, Copernicus Hospital, Department of Hematology
Lodz, Poland, 93-510
Institute of Haematology and Transfusion Medicine
Warsaw, Poland, 02-776
Independent Public Pediatric Teaching Hospital, Clinical Department of Hematology and Pediatrics
Warsaw, Poland, 00-579
Romania
Louis Turcanu Emergency Clinical Children´s Hospital
Timisoara, Romania
Russian Federation
Federal State Institution Kirov, Hematology and Blood Transfusion Research Institute under the Federal Agency for High-Tech Medical Care
Kirov, Russian Federation, 610027
Children's Territorial Clinical Hospital
Krasnodar, Russian Federation, 350007
Hematology Research Center RAMS
Moscow, Russian Federation, 125167
Sweden
Malmö University Hospital, Department of Coagulation Disorders
Malmö, Sweden, 205 02
Ukraine
State Institution "Institute of Blood Pathology and Transfusion Medicine under the Academy of Medical Sciences of Ukraine"
Lviv, Ukraine, 79044
United Kingdom
Royal Manchester Children's Hospital, Department of Hematology
Manchester, United Kingdom, M13 9WL
Sponsors and Collaborators
Baxter Healthcare Corporation
Baxter Innovations GmbH
Investigators
Study Director: Srilatha Tangada, PhD Baxter Healthcare Corporation
  More Information

No publications provided

Responsible Party: Baxter Healthcare Corporation
ClinicalTrials.gov Identifier: NCT01507896     History of Changes
Other Study ID Numbers: 251002, 2011-000413-39
Study First Received: January 9, 2012
Last Updated: May 28, 2014
Health Authority: Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica
Bulgaria: Bulgarian Drug Agency
Chile: Instituto de Salud Pública de Chile
Colombia: INVIMA Instituto Nacional de Vigilancia de Medicamentos y Alimentos
Czech Republic: State Institute for Drug Control
Japan: Pharmaceuticals and Medical Devices Agency
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Romania: National Medicines Agency
Russia: FSI Scientific Center of Expertise of Medical Application
Sweden: Medical Products Agency
Ukraine: State Pharmacological Center - Ministry of Health
United Kingdom: Medicines and Healthcare Products Regulatory Agency
United States: Food and Drug Administration

Additional relevant MeSH terms:
Hemophilia B
Blood Coagulation Disorders
Blood Coagulation Disorders, Inherited
Coagulation Protein Disorders
Genetic Diseases, Inborn
Genetic Diseases, X-Linked
Hematologic Diseases
Hemorrhagic Disorders

ClinicalTrials.gov processed this record on October 30, 2014