BAX 326 (recombinant coagulation factor nine): Continuation of a study of the safety and efectiveness of the product in previously treated patients with severe or moderately severe hemophilia B.
- Conditions
- Previously treated patients with severe (FIX level < 1%) or moderately severe (FIX level = 2%) hemophilia B.MedDRA version: 14.1 Level: LLT Classification code 10018939 Term: 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-GB
- Lead Sponsor
- Baxter Innovations GmbH
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 117
• The subject and/or legal representative has/have voluntarily provided signed informed consent.
• The subject has completed Baxter Pivotal Study 250901 or Pediatric Study 251101.
• The subject was aged 12 to 65 years old at the time of screening for 250901 or <12 years old at the time of screening for Pediatric Study 251101.
• The subject has not developed an inhibitory FIX antibody during Baxter Pivotal Study 250901 or Pediatric Study 251101.
• The subject is human immunodeficiency (HIV) negative or is HIV+ with a viral load < 200 particles/µL ~ < 400,000 copies/mL.
• The 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.
• The 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: 30
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 70
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 protocol 250901 or Pediatric Study 251101.
• The subject has been diagnosed with an acquired hemostatic defect other than hemophilia B.
• For subjects transferring from Pivotal Study 250901: The subject’s weight is < 35 kg or > 120 kg.
4. 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 a-interferon) other than antiretroviral
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
- Secondary Outcome Measures
Name Time Method