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BAX 326 Surgery Study

This study is currently recruiting participants.
Verified July 2012 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: July 19, 2012
Last verified: July 2012
History of Changes
  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:

Drug Information available for: Factor IX
U.S. FDA Resources

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 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


Secondary Outcome Measures:
  • 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 BAX 326 [ 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 ]

Estimated Enrollment: 30
Study Start Date: December 2011
Estimated Study Completion Date: March 2015
Estimated Primary Completion Date: March 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, subjects will receive BAX 326 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: BAX 326

  Eligibility

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

Main Inclusion Criteria:

  • Subject and/or legal representative has/have voluntarily provided signed informed consent.
  • Subject has severe (FIX level < 1%) or moderately severe (FIX level 1-2%) hemophilia B (based on the one stage aPTT assay), as tested at screening at the central laboratory.
  • Subject is immunocompetent as evidenced by a CD4 count >= 200 cells/mm3.
  • Subject is human immunodeficiency (HIV) negative or is HIV+ with a viral load < 200 particles/μL ~ < 400,000 copies/mL.

Main Exclusion Criteria:

  • The subject 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.
  • The subject has a detectable FIX inhibitor at screening, with a titer ≥0.6 BU as determined by the Nijmegen modification of the Bethesda assay in the central laboratory.
  • The subject 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: Katharina Trinks, Clinical Project Manager katharina_trinks@baxter.com

  Show 25 Study Locations
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: July 19, 2012
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
India: Drugs Controller General of India
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
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 May 23, 2013