EUCTR2009-014295-21-DE进行中（未招募）不适用
B-LONG: An Open-label, Multicenter Evaluation of the Safety, Pharmacokinetics, and Efficacy of Recombinant, Long-acting Coagulation Factor IX Fc fusion protein (rFIXFc) in the Prevention and Treatment of Bleeding in Previously Treated Subjects With Severe Hemophilia B - B-Long
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 100
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- Male
入选标准
- •To be eligible to participate in this study, candidates must meet the following eligibility criteria at Screening:
- •1. 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
- •2. Male and =12 years of age and weigh at least 40 kg
- •3. Have severe hemophilia B defined as =2 IU/dL (=2%) endogenous FIX activity as determined from the central laboratory at the time of screening. If the screening result is >2%, then the severity of hemophilia B may be confirmed by documented historical evidence from a certified clinical laboratory demonstrating =2% FIX:C from the medical record or from a documented genotype known to produce severe hemophilia B;
- •4. Be a previously treated subject, defined as having at least 100 prior EDs to any recombinant or plasma-derived FIX product (fresh frozen plasma treatment must not be considered in the count of the documented EDs)
- •5. Have had bleeding events and/or treatment with FIX during the prior 12 weeks, as documented in the subjects’ medical record
- •6. =8 bleeds in the 52 weeks prior to enrollment on the study if currently treating with an on-demand regimen
- •7. A platelet count =100,000 cells/µL
- •8. Immunocompetent as determined by the investigator’s review of the subject’s medical history
- •9. Viral load of <400 copies/mL, if human immunodeficiency virus (HIV) antibody positive;
- •10. An international normalized ratio (INR) <1.40 as defined by the testing laboratory’s normal range.
- •11. For subjects entering directly into Treatment Arm 4 (Surgery), the subject meets all other eligibility criteria AND requires major elective surgery.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 20
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 78
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 2
排除标准
- •Candidates will be excluded from study entry if any of the following exclusion criteria exist at Screening:
- •1. Prior history of, or currently detectable inhibitor as defined by the reporting laboratory (family history of inhibitors will not exclude the subject. A positive inhibitor value is =0.6 BU/mL (=1.0 BU/mL only for laboratories with a historical lower sensitivity cut-off for inhibitor detection of 1.0 BU/mL).
- •2. Other coagulation disorder(s) in addition to hemophilia B;
- •3. Prior history of anaphylaxis associated with any FIX or IV immunoglobulin administration
- •4. Abnormal renal function defined as serum creatinine >2.0 mg/dL
- •5. Active hepatic disease defined as an aspartate aminotransferase (AST) or alanine aminotransferase (ALT) greater than 5 times the upper limit of normal
- •6. For the Sequential PK subgroup receiving BeneFIX: allergy to Chinese Hamster proteins
- •7. Any concurrent clinically significant major disease that, in the opinion
- •8. Subjects who are unable or unwilling to refrain from taking additional prophylactic doses of FIX prior to sports activity or increased physical activity
- •9. Concurrent systemic treatment with immunosuppressant drugs within the last 12 weeks prior to the study entry (Exceptions: ribavirin, treatment of hepatitis C virus [HCV] and HIV and/or systemic steroids [a total of 2 pulse treatments within 7 days =1mg/kg] and/or inhaled steroids)
- •10. Current enrollment within the past 30 days in any other clinical study involving investigational drugs.
- •11. Unable to enter accurate and timely information regarding injections and bleeding episodes into an electronic patient diary and without adequate parental/caregiver support to manage this (per the Investigator’s judgment).
研究者
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