BAX 326 Surgery Study
This study is currently recruiting participants.
Verified July 2012 by Baxter Healthcare Corporation
Sponsor:
Baxter Healthcare Corporation
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
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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:
Genetics Home Reference related topics:
hemophilia
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
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Contacts
| Contact: Katharina Trinks, Clinical Project Manager | katharina_trinks@baxter.com |
Hide Study LocationsLocations
| Argentina | |
| Instituto de Hematología y Medicina Clínica Rubén Dávoli | Not yet recruiting |
| Rosario, Argentina, 2000 | |
| Brazil | |
| UNIFESP - Universidade Estadual de Sao Paulo | Recruiting |
| Sao Paulo, Brazil, 040024-002 | |
| Bulgaria | |
| Specialized Haematological Hospital "Joan Pavel" | Recruiting |
| Sofia, Bulgaria, 1233 | |
| Chile | |
| Hospital Dr. Sotero del Rio | Not yet recruiting |
| Santiago, Chile | |
| Colombia | |
| Hospital de San Jose | Not yet recruiting |
| Bogotá, Colombia | |
| Centro Medico Imbanaco | Not yet recruiting |
| Cali, Colombia | |
| Czech Republic | |
| Klinika detska hematologie a onkologie UK 2. LF a FN Motol | Not yet recruiting |
| Prague, Czech Republic, 150 06 | |
| Japan | |
| Hiroshima University Hospital, Department of Internal Medicine | Not yet recruiting |
| Hiroshima, Japan | |
| Nara Medical University Hospital, Department of Pediatrics | Not yet recruiting |
| Nara, Japan, 634-8251 | |
| Jichi Medical University Hospital | Not yet recruiting |
| Tochigi, Japan, 329-0498 | |
| Tokyo Medical University Hospital | Not yet recruiting |
| Tokyo, Japan, 160-0023 | |
| Ogikubo Hospital, Department of Hematology and Pediatrics | Not yet recruiting |
| Tokyo, Japan, 167-0035 | |
| Poland | |
| Medical University Hospital - University Clinic Centre, Hematology and Transplantology Clinic | Recruiting |
| Gdansk, Poland, 80-952 | |
| Medical College of the Jagiellonian University | Recruiting |
| Krakow, Poland, 31-501 | |
| Medical University Lodz, Copernicus Hospital, Department of Hematology | Recruiting |
| Lodz, Poland, 93-510 | |
| Institute of Haematology and Transfusion Medicine | Recruiting |
| Warsaw, Poland, 02-776 | |
| Independent Public Pediatric Teaching Hospital, Clinical Department of Hematology and Pediatrics | Recruiting |
| Warsaw, Poland, 00-576 | |
| Romania | |
| Prof. Dr. C.T. Nicolau National Institute for Transfusional Hematology | Recruiting |
| Bucharest, Romania, 11156 | |
| 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 | |
| Hematology Research Center RAMS | Recruiting |
| Moscow, Russian Federation, 125167 | |
| Republican Center for Hemophilia Treatment | Recruiting |
| St. Petersburg, Russian Federation, 195213 | |
| 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 | |
| Katharine Dormandy Haemophilia Centre and Haemostasis Unit, Royal Free Hospital | Not yet recruiting |
| London, United Kingdom, NW3 2 QG | |
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 June 18, 2013