EUCTR2012-004434-42-GB进行中（未招募）1 期
A multi-center, phase III, non-controlled, open-label trial to evaluate the pharmacokinetics,safety, and efficacy of BAY 94-9027 for prophylaxis and treatment of bleeding in previouslytreated children (age <12 years) with severe hemophilia A - PROTECT KIDS
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- Bayer AG
- 入组人数
- 61
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
- •1. Male, age <12 years to be enrolled in 2 subgroups:
- •- age 6 to <12 years
- •- age < 6 years
- •Subjects in the expansion group are to be <6 years of age.
- •2. Severe hemophilia A defined as < 1% factor VIII concentration (FVIII:C) by measurement at the time of screening or from reliable prior documentation (eg, measurement in other clinical trials, results from approved clinical laboratory, or
- •diagnostic genetic testing)
- •3. > 50 ED with any FVIII concentrate(s) (plasma derived or recombinant)
- •4. Willingness and ability of subjects and/or parents to complete training in the use of the
- •EPD and to document infusions during the study
- •5. Written informed consent by parent/legal representative. Assent should be sought from
- •subjects, if appropriate
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 60
- •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. Current evidence of inhibitor to FVIII measured using the Nijmegen-modified Bethesda assay (>0.6 BU/mL) at the time of screening (central laboratory). Subjects should not have received FVIII within 72 h prior to the collection of screening
- •samples and should have had FVIII administered within the prior 2-3 weeks.
- •2. History or presence of Factor VIII inhibitors. Inhibitor to FVIII is defined as a titer
- •>0.6 BU/mL or clinical history suggestive of inhibitor requiring modification of treatment. (Subjects with a maximum historical titer of <1.0 BU on no more than 1 occasion with the classical Bethesda assay but at least 3 subsequent negative results [<0.6 BU] are eligible.)
- •3. Any other inherited or acquired bleeding disorder in addition to hemophilia A
- •4. Platelet count < 100,000/mm3
- •5. Creatinine > 2x upper limit of normal
- •6. Aspartate aminotransferase (AST) or Alanine aminotransferase (ALT) > 5x upper
- •limit of normal
- •7. Known hypersensitivity to the drug substance, or any of its components (eg, mouse or
- •hamster protein)
- •8. The subject is currently participating in another investigational drug study, or has participated in a clinical study involving an investigational drug within 30 days of study entry. Subjects who are currently participating in an investigational study in
- •which they are treated with a currently marketed FVIII concentrate are not excluded. Subjects currently treated with BAY 81-8973 may continue treatment with the product
- •up to the start of Visit 1.
- •9. Any individual who is receiving chemotherapy, immune modulatory drugs other than anti-retroviral chemotherapy, or chronic use of oral or intravenous (IV) corticosteroids (> 14 days) within the last 3 months.
- •10. The subject is identified by the investigator as being unable or unwilling to perform study procedures.
- •Subjects should not be enrolled with clinical history suggestive of an inhibitor. Clinical history suggestive of an inhibitor may include known history of reduced recovery or shortened half-lives, or the need to modify treatment on the basis of a positive inhibitor test.
- •11. Previous assignment to treatment during this study.
研究者
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A multi-center, phase III, non-controlled, open-label trial to evaluate the pharmacokinetics, safety, and efficacy of BAY 94-9027 for prophylaxis and treatment of bleeding in previously treated children (age < 12 years) with severe hemophilia A.10064477Hemophilia ANL-OMON45210Bayer5