EUCTR2015-002136-40-IT进行中（未招募）1 期
A study of safety, effect on the immune system and blood clotting ofBAX855 (factor VIII of blood clotting) in pediatric patients who have not received or received minimal treatment for their severe hemophilia A. - BAX855 PUP study
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 120
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
- All
入选标准
- •1. Subject is < 6 years old at the time of screening
- •2. Subject is previously untreated with <3 EDs to ADVATE, BAX 855 or fresh frozen plasma (FFP) at any time prior to screening
- •3. Subject has severe hemophilia A (FVIII < 1%) as determined by the central laboratory, or a historical FVIII level < 1% as determined at any local laboratory and an optional additional FVIII gene mutation consistent with severe hemophilia A
- •4. Subject is immune competent with a CD4+ count > 200 cells/mm3, as confirmed by central laboratory at screening
- •5. Parent or legally authorized representative is willing and able to comply with the requirements of the protocol.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) no
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. Subject has detectable FVIII inhibitory antibodies (= 0.6 BU using the Nijmegen modification of the Bethesda assay) as confirmed by central laboratory at screening
- •2. Subject has a history of FVIII inhibitory antibodies (= 0.6 BU using the Nijmegen modification of the Bethesda assay or the Bethesda assay) at any time prior to screening
- •3. Subject has been diagnosed with an inherited or acquired hemostatic defect other than hemophilia A (eg, qualitative platelet defect or von Willebrand's disease)
- •4. Subject has been previously treated with cryoprecipitate or any type of FVIII concentrate other than ADVATE or BAX 855, or was administered ADVATE or BAX 855 for = 3 EDs at any time prior to
- •5. Subject has received any kind of blood-transfusion such as packed red blood cells (PRBC), platelets or plasma at any time prior to screening
- •6. The subject's weight is < 5 kg (If a subject is close to weighing 5 kg at screening and will have reached a weight of at least 5 kg at the baseline visit, the subject is eligible for participation.)
- •7. Subject's platelet count is < 100,000/mL
- •8. Subject has known hypersensitivity towards mouse or hamster proteins, PEG or Tween 80
- •9. Subject has severe chronic hepatic dysfunction [eg, > 5 times upper limit of normal alanine aminotransferase (ALT), aspartate aminotransferase (AST), or a documented INR > 1.5] in his medical
- •history or at the time of screening
- •10. Subject has severe renal impairment (serum creatinine > 1.5 times the upper limit of normal)
- •11. Subject has current or recent (< 30 days) use of other PEGylated drugs prior to study participation or is scheduled to use such drugs during study participation
- •12. Subject is scheduled to receive during the course of the study a systemic immunomodulating drug (e.g. corticosteroid agents at a dose
- •equivalent to hydrocortisone greater than 10 mg/day, or a-interferon) other than antiretroviral
- •chemotherapy
- •13. Subject has participated in another clinical study involving an IP or investigational device within 30 days prior to enrollment or is scheduled to participate in another clinical study involving an IP or investigational device during the course of this study
- •14. Parent or legally authorized representative has a medical, psychiatric, or cognitive illness or recreational drug/alcohol use that, in the opinion of the investigator, would affect subject safety or compliance
- •15. Parent, legally authorized representative or subject are a member of the team conducting this study or is in a dependent relationship with one
- •of the study team members. Dependent relationships include close relatives (ie, children, partner/spouse, siblings, parents) as well as
- •employees of the investigator or site personnel conducting the study.
研究者
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