EUCTR2009-014295-21-NL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 SevereHemophilia B - B-Long
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 75
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 subject privacy regulations. If the subject is younger than 18 years old, then a parent or guardian needs to sign the ICF and the subject needs to sign the assent form as consistent with local authorities.
- •2-Male =12 years of age, and weigh at least 40 kg
- •3-Severe hemophilia B defined as =2 IU/dL (=2%) endogenous FIX documented in the medical record
- •4-A previously treated subject, defined as having at least 100 prior exposure days to any FIX product (historical data from subject records and/or subject history)
- •5-Bleeding events and/or treatment with FIX during the last 3 months as documented in the subjects’ medical records
- •6-Greater than or equal to 4 bleeds in the 6 months prior to enrollment in the study if currently treating with an on-demand regimen.
- •7-At least 4 days since the subject’s last dose of FIX.
- •8-A platelet count =100,000 cells/µL
- •9-CD4 count =200 cells/µL if subject is HIV antibody positive, based on recent lab result (within one year)
- •10-An INR =1.3 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 a major elective surgery defined as surgery that requires at least 4 days of FIX coverage.
- •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
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)
- •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 AST or ALT greater than 5 times the upper limit of normal
- •6. For Sequential PK subgroup: 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. 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 =1 mg/kg])
- •9. Current treatment with any investigational product or medical device within the past 30 days of the first dose of study treatment.
研究者
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