EUCTR2009-014295-21-PL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
Biogen Idec Inc., 9 Fourth Avenue,Waltham, MA 02451, USA0 个研究点目标入组 123 人开始时间: 2010年5月17日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 123
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. Able to understand the purpose and risks of the study and provide signed and dated informed consent and authorization to use protected health information (PHI) in accordance with national and local subjects privacy regulations. If the subject is younger than 18 years old, then a parent or guardian needs to sign the informed consent form (ICF) and the subject needs to sign the assent form as consistent with local authorities.
- •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 110
- •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 of the investigator, makes the subject unsuitable for enrollment
- •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
相似试验
进行中（未招募）
1 期
A clinical study involving people with severe haemophilia B to look at how safe an experimental replacement factor IX protein (known as rFIXFc) is to take and how well it works to prevent and stop bleeds.EUCTR2009-014295-21-GBBiogen Idec Hemophilia Inc.123
进行中（未招募）
1 期
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-LongThe medical condition to be investigated is Hemophilia B, or Christmas disease. Hemophilia B is a deficiency in the clotting FIX and is a recessively inherited coagulation disorder due to an X-chromosome mutation carried by females and expressed mainly by males, affecting approximately 80,000 people worldwide.MedDRA version: 12.1Level: LLTClassification code 10053754Term: Hemophilia B without inhibitorsEUCTR2009-014295-21-FRBiogen Idec, Inc.123
进行中（未招募）
不适用
A clinical study involving people with severe haemophilia B to look at how safe an experimental replacement factor IX protein (known as rFIXFc) is to take and how well it works to prevent and stop bleeds.EUCTR2009-014295-21-DEBiogen Idec Inc.100
进行中（未招募）
不适用
A clinical study involving people with severe haemophilia B to look at how safe an experimental replacement factor IX protein (known as rFIXFc) is to take and how well it works to prevent and stop bleeds.EUCTR2009-014295-21-SEBiogen Idec Hemophilia Inc.123
进行中（未招募）
1 期
A clinical study involving people with severe haemophilia B to look at how safe an experimental replacement factor IX protein (known as rFIXFc) is to take and how well it works to prevent and stop bleeds.The medical condition to be investigated is Hemophilia B, or Christmas disease. Hemophilia B is a deficiency in the clotting FIX and is a recessively inherited coagulation disorder due to an X-chromosome mutation carried by females and expressed mainly by males, affecting approximately 80,000 people worldwide.MedDRA version: 14.1Level: LLTClassification code 10053754Term: Hemophilia B without inhibitorsSystem Organ Class: 10010331 - Congenital, familial and genetic disordersEUCTR2009-014295-21-BEBiogen Idec Hemophilia Inc.123