BAX 326 Surgery Study

This study is currently recruiting participants.
Verified December 2013 by Baxter Healthcare Corporation
Sponsor:
Collaborator:
Baxter Innovations GmbH
Information provided by (Responsible Party):
Baxter Healthcare Corporation
ClinicalTrials.gov Identifier:
NCT01507896
First received: January 9, 2012
Last updated: December 2, 2013
Last verified: December 2013
  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 ]

Estimated Enrollment: 40
Study Start Date: December 2011
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2015 (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 Name: BAX326

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

Contacts
Contact: Christiane Thomasser, Clinical Project Manager christiane_thomasser@baxter.com

Locations
Argentina
Instituto de Hematología y Medicina Clínica Rubén Dávoli Not yet recruiting
Rosario, Argentina, 2000
Bulgaria
Specialized Haematological Hospital "Joan Pavel" Recruiting
Sofia, Bulgaria, 1233
Chile
Hospital Dr. Sotero del Rio Not yet recruiting
Santiago, Chile
Colombia
Centro Medico Imbanaco Recruiting
Cali, Colombia
Czech Republic
Klinika detska hematologie a onkologie Recruiting
Prague, Czech Republic, 150 06
Japan
Ogikubo Hospital, Department of Hematology and Pediatrics Withdrawn
Tokyo, Japan, 167-0035
Poland
Medical University Hospital - University Clinic Centre, Hematology and Transplantology Clinic Not yet recruiting
Gdansk, Poland, 80-952
Medical University Lodz, Copernicus Hospital, Department of Hematology Recruiting
Lodz, Poland, 93-510
Independent Public Pediatric Teaching Hospital, Clinical Department of Hematology and Pediatrics Not yet recruiting
Warsaw, Poland, 00-579
Institute of Haematology and Transfusion Medicine Recruiting
Warsaw, Poland, 02-776
Romania
Louis Turcanu Emergency Clinical Children´s Hospital Recruiting
Timisoara, Romania
Russian Federation
Federal State Institution Kirov, Hematology and Blood Transfusion Research Institute under the Federal Agency for High-Tech Medical Care Recruiting
Kirov, Russian Federation, 610027
Children's Territorial Clinical Hospital Not yet recruiting
Krasnodar, Russian Federation, 350007
Hematology Research Center RAMS Recruiting
Moscow, Russian Federation, 125167
Sweden
Malmö University Hospital, Department of Coagulation Disorders Not yet recruiting
Malmö, Sweden, 205 02
Ukraine
State Institution "Institute of Blood Pathology and Transfusion Medicine under the Academy of Medical Sciences of Ukraine" Recruiting
Lviv, Ukraine, 79044
United Kingdom
Royal Free Hopital Withdrawn
London, United Kingdom, NW3 2QG
Royal Manchester Children's Hospital, Department of Hematology Not yet recruiting
Manchester, United Kingdom, M13 9WL
Sponsors and Collaborators
Baxter Healthcare Corporation
Baxter Innovations GmbH
Investigators
Study Director: Brigitt Abbuehl, MD Baxter Innovations GmbH
  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: December 2, 2013
Health Authority: Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica
Bulgaria: Bulgarian Drug Agency
Chile: Instituto de Salud Publica 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

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

ClinicalTrials.gov processed this record on April 17, 2014