BAX 326 (recombinant coagulation factor nine): Continuation of a studyof the safety and effectiveness of the product in previously treatedpatients with severe or moderately severe hemophilia B.
- Conditions
- Previously treated patients (PTPs) with severe (FIX level < 1%) or moderately severe (FIXlevel 2%) hemophilia BMedDRA version: 14.0Level: LLTClassification code 10018939Term: Haemophilia B (Factor IX)System Organ Class: 10010331 - Congenital, familial and genetic disordersTherapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]
- Registration Number
- EUCTR2010-022726-33-ES
- Lead Sponsor
- Baxter Innovations GmbH
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 60
? The subject and/or legal representative has/have voluntartily
provided signed informed consent.
? Subject has completed Baxter clinical study 250901.
? Subject was 12 to 65 years old at the time of screening for 250901
study.
? Subject has severe (FIX level < 1%) or moderately severe (FIX level
? 2%) hemophilia B (based on the one stage activated partial
thromboplastin time (aPTT) assay), as tested at screening at the central
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laboratory.
? Subject has not developed an inhibitory FIX antibody during Baxter
clinical study 250901.
? Subject is human immunodeficiency (HIV) negative or is HIV+ with a
viral load < 200 particles/?L ~ <400,000 copies/mL
? Subject is immunocompetent as evidenced by a CD4 count ? 200
cells/mm3.
? If female of childbearing potential, subject presents with a negative
pregnancy test and agrees to continue employing adequate birth control
measures for the duration of the study.
? Subject is willing and able to comply with the requirements of the
protocol.
Are the trial subjects under 18? yes
Number of subjects for this age range: 1
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 1
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
? The subject received factor IX product(s) other than BAX 326 upon
completion of Baxter pivotal study 250901.
? The subject has been diagnosed with an acquired hemostatic defect
other than hemophilia B.
? The subject's weight is < 35 kg or > 120 kg.
? The subject's platelet count is < 100,000/mL.
? The subject has an abnormal renal function (serum creatinine > 1.5
times the upper limit of normal).
? The subject has active hepatic disease with alanine aminotransferase
(ALT) or aspartate aminotransferase (AST) levels ? 5 times the upper
limit of normal.
? The subject is scheduled to receive during the course of the study, an
immunomodulating drug (e.g. corticosteroid agents at a dose equivalent
to hydrocortisone greater than 10 mg/day, or ?-interferon) other than
anti-retroviral chemotherapy.
? The subject has a clinically significant medical, psychiatric, or
cognitive illness, or recreational drug/alcohol use that, in the opinion of
the investigator, would affect subject's safety or compliance.
? The 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.
? The subject is a member of the team conducting this study or is in a
dependent relationship with one of the study team members. Dependent
relationships include close relatives (i.e., children, partner/spouse,
siblings, parents) as well as employees of the investigator or site
personnel conducting the study.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To further evaluate safety, immunogenicity, and hemostatic efficacy of BAX 326 in those<br>subjects who completed pivotal study 250901, until BAX 326 is licensed in the subjects<br>country or until the total accumulation of at least 100 exposure days (EDs) of treatment with<br>BAX 326, whichever occurs last<br> To monitor incremental recovery of BAX 326 over time<br> To evaluate changes in health-related quality of life (HR QoL) and health resource use;Secondary Objective: n.a.;Primary end point(s): Adverse events possibly or probably related to IP;Timepoint(s) of evaluation of this end point: end of the trial
- Secondary Outcome Measures
Name Time Method Secondary end point(s): Safety and immunogenicity<br>Pharmacokinetics<br>Hemostatic efficacy<br>Health related Quality of Life and Health Resource Use;Timepoint(s) of evaluation of this end point: end of the trial