CTRI/2012/08/002877已完成2 期
A Phase 2/3 prospective, uncontrolled, multicenter study evaluating pharmacokinetics, efficacy, safety and immunogenicity in previously treated pediatric patients with severe (FIX level less than 1%) or moderately severe (FIX level less than and equal to 2%) hemophilia B
Baxter Innovation GmBH0 个研究点目标入组 24 人开始时间: 待定最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 24
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •Subject and/or legal representative has/have voluntarily provided signed informed consent
- •Subject has severe (FIX level < 1%) or moderately severe (FIX level <= 2%) hemophilia B based on the one-stage activated partial thromboplastin time (aPTT) assay, as determined by the central laboratory
- •Subject is < 12 years old at the time of screening
- •Subject 6 to <12 years of age is previously treated with plasma-derived and/or recombinant FIX concentrate(s) for a minimum of 150 EDs (based on the subjectâ??s medical records).
- •If a subject does not have a verifiable, documented history of 150 EDs, s/he can be enrolled if the following criteria are met:
- •1) there are an estimated 100 - 150 EDs to any FIX product (plasma-derived or recombinant FIX concentrate(s), prothrombin complex concentrate ï??PCCï?? or fresh frozen plasma ï??FFPï?? that are not fully documented (assumption based on the severity of disease and treatment history), and
- •2) s/he has participated in Immunine Study 050901 and accumulated either at least 50 EDs to Immunine or a total of at least 150 EDs to a plasma-derived and/or recombinant FIX concentrate prior to enrollment
- •Subject < 6 years of age is previously treated with plasma-derived and/or recombinant FIX concentrate(s) for > 50 EDs (based on the subjectâ??s medical records).
- •If a subject does not have a verifiable, documented history of >50 EDs, s/he can be enrolled if the following criteria are met:
- •1) there are approximately 20 - 50 EDs to any FIX product (plasma-derived or recombinant FIX concentrate(s), PCC or FFP) that are not fully documented, and
- •2) s/he has participated in Immunine Study 050901 and accumulated a minimum of 30 EDs to Immunine or a total of > 50 EDs to a plasma-derived and/or recombinant FIX concentrate prior to enrollment
- •Subject has no evidence of a history of FIX inhibitors (based on the subjectâ??s medical records). If a verifiable, documented history is unavailable, the subject can be enrolled if s/he has participated in Study 050901 for at least 30 EDs ( < 6 years of age) or at least 50 EDs (6 to < 12 years of age) to Immunine prior to enrollment
- •Subject and/or legal representative accepts prophylactic treatment over a period of 6 months
排除标准
- •Subject has a history of FIX inhibitors with a titer >= 0.6 BU (as determined by the Nijmegen modification of the Bethesda assay or the assay employed in the respective local laboratory with the corresponding detection limit) at any time prior to screening
- •Subject has a detectable FIX inhibitor at screening, with a titer >= 0.6 BU as determined by the Nijmegen modification of the Bethesda assay in the central laboratory
- •Subject has a history of allergic reaction, e.g. anaphylaxis, following exposure to FIX concentrate(s)
- •Subject has a known hypersensitivity to hamster proteins or rFurin
- •Subject has evidence of an ongoing or recent thrombotic disease, fibrinolysis or disseminated intravascular coagulation (DIC)
- •Subject has an abnormal renal function (serum creatinine 1.5 times the upper limit of normal)
- •Subject has an International Normalized Ratio (INR) 1.4
- •Subject has active hepatic disease with alanine aminotransferase (ALT) or aspartate aminotransferase (AST) levels 5 times the upper limit of normal
- •Subject has been diagnosed with an inherited or acquired hemostatic defect other than hemophilia B
- •Subjectâ??s platelet count is 100,000/mL
- •Subject has a clinically significant medical, psychiatric, or cognitive illness, that, in the opinion of the Investigator, would affect subjectâ??s safety or compliance
- •Subject is currently receiving, or 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 α-interferon) other than anti-retroviral chemotherapy
- •Subject has participated in another investigational study within 30 days of enrollment. However, participation in Study 050901 with Immunine is allowed.
研究者
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