B-LONG: An Open-label, Multicenter Evaluation of the Safety, Pharmacokinetics, and Efficacy of Recombinant, Long-acting Coagulation Factor IX Fc fusion (rFIXFc) in the Prevention and Treatment of Bleeding in Previously Treated Subjects With Severe Hemophilia B - B-Long

Biogen Idec, Inc.0 个研究点目标入组 75 人开始时间: 2010年9月29日最近更新: 2012年10月16日

试验速览

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•Given written informed consent and any authorizations required by local law (e.g., Protected Health Information). Parental or guardian consent is required for subjects who are less than 18 years; • Male and =12 years of age and weighs at least 40 kg; • Have severe hemophilia B defined as =2 IU/dL (=2%) endogenous FIX documented in the medical record; • Be a previously treated subject, defined as having at least 100 EDs to any FIX product Have had bleeding events and/or treatment with FIX during the last 3 months documented in the subjects’ medical record; • =4 bleeds in the 6 months prior to enrollment on the study if currently treating with an on-demand regimen; • It has been at least 4 days since the subject’s last dose of FIX; • A platelet count =100,000 cells/µL; • CD4 count =200 cells/ µL if subject is HIV antibody positive, based on recent lab result (within one year); • An INR =1.3 as defined by the testing laboratory’s normal range.
•Are the trial subjects under 18? yes
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range

•Prior history of, or currently detectable inhibitor as defined by the reporting laboratory (family history of inhibitors will not exclude the subject); • Other coagulation disorder(s) in addition to hemophilia B; • Prior history of anaphylaxis associated with any FIX or IV immunoglobulin administration; • Abnormal renal function defined as serum creatinine >2.0 mg/dL; • Active hepatic disease defined as an AST or ALT greater than 5 times the upper limit of normal; • For the Sequential PK subgroup receiving BeneFIX: allergy to Chinese Hamster proteins; • Any concurrent clinically significant major disease that, in the opinion of the Investigator makes the subject unsuitable for enrollment; • Concurrent systemic treatment with immunosuppressant drugs within the last 3 months prior to the study entry (allowed: interferon-a for hepatitis C, highly active antiretroviral treatment [HAART] for HIV and/or steroids [2 pulse treatments / 7 days =1mg/kg]); • Current enrollment or enrollment within the past 30 days in any other investigational drug treatment study.

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