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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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25 March 2013 |
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Main ID: |
NCT01286779 |
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Date of registration:
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26/01/2011 |
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Primary sponsor: |
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Public title:
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BAX 326 (rFIX) Continuation Study
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Scientific title:
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BAX 326 (Recombinant Factor IX): Evaluation of Safety, Immunogenicity, and Hemostatic Efficacy in Previously Treated Patients With Severe (FIX Level < 1%) or Moderately Severe (FIX Level <= 2%) Hemophilia B - A Continuation Study |
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Date of first enrolment:
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April 2011 |
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Target sample size:
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100 |
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Recruitment status: |
Recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT01286779 |
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Study type:
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Interventional |
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Study design:
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Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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Countries of recruitment
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Argentina
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Brazil
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Bulgaria
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Chile
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Colombia
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Czech Republic
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Germany
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Japan
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Poland
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Romania
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Russian Federation
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Spain
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Sweden
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Ukraine
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United Kingdom
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Contacts
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Name:
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Susanne Schmiedl, Clinical Project Manager |
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Address:
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Telephone:
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Email:
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susanne_schmiedl@baxter.com |
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Affiliation:
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Name:
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Brigitt Abbuehl, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Baxter Innovations GmbH |
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Key inclusion & exclusion criteria
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Main Inclusion Criteria:
- Subject and/or legal representative has/have voluntarily provided signed informed
consent
- Subject has completed Baxter clinical study 250901 (pivotal study) or Baxter clinical
study 251101 (pediatric study)
- Subject was 12 to 65 years old at the time of screening for Study 250901 or < 12
years old at the time of screening for Study 251101
- Subject 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
- Subject has not developed an inhibitory FIX antibody during Baxter Pivotal Study
250901 or Pediatric Study 251101
Main Exclusion Criteria:
- Subject received factor IX product(s) other than BAX 326 upon completion of Baxter
Pivotal Study 250901 or Pediatric Study 251101
- Subject has been diagnosed with an acquired hemostatic defect other than hemophilia B
- For subjects transferring from Pivotal Study 250901: Subject's weight is < 35 kg or >
120 kg
- Subject is planned to take part in any other clinical study, with the exception of
BAX 326 Surgery study as described in this protocol, during the course of the
Continuation Study
Age minimum:
N/A
Age maximum:
65 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Hemophilia B
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Intervention(s)
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Biological: BAX 326 (Recombinant factor IX)
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Primary Outcome(s)
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Adverse events possibly or probably related to the investigational product
[Time Frame: Assessed (based on patient diary) every 3 months until study completion]
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Secondary ID(s)
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2010-022726-33
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251001
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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