EUCTR2008-008435-29-GR进行中（未招募）1 期
A Non-Randomized, Open-Label Study to Evaluate the Pharmacokinetics, Safety, and Efficacy of ReFacto AF in Previously Treated Pediatric Subjects Less Than Twelve Years of Age With Severe Hemophilia A (FVIII:C <1%)
Wyeth Research Division of Wyeth Pharmaceuticals Inc. Clinical Research and Development0 个研究点目标入组 50 人开始时间: 2009年10月6日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 50
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 subjects <12 years of age with a documented history of severe hemophilia A (FVIII:C <1%).
- •a) Subjects who are <6 years of age must have had at least 1 exposure day to prior FVIII products (including blood products).
- •b) Subjects who are =6 years of age must have had greater than 150 exposure days to prior FVIII products (including blood products)
- •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) For laboratory assessments, any measured Bethesda inhibitor titer =0.6 BU, regardless of the laboratory normal range, or any Bethesda inhibitor titer > ULN for the testing laboratory at the time of screening.
- •2) Any other bleeding disorder in addition to hemophilia A.
- •3) Treatment with any investigational drug or device within 28 days before the time of signing the parental informed consent/assent form.
- •4) Major surgery planned to occur during the course of the study.
- •5) Regular (e.g., daily; every other day) use of agents or medications known to influence platelet function such as aspirin or certain nonsteroidal anti-inflammatory drugs (NSAIDS).
- •6) Regular, concomitant therapy with immunomodulating drugs (e.g., intravenous immunoglobulin [IVIG], routine systemic corticosteroids), or currently receiving immune tolerance induction (ITI) for inhibitor treatment.
- •7) The subject is receiving treatment for HIV or hepatitis infection (exceptions may be made for subjects on a stable antiviral regimen [i.e., consistent treatment regimen for at least 3 months before signing the parental informed consent/assent form]).
- •8) Platelet count <100,000/µL.
- •9) Prothrombin time (PT) =1.25 x ULN, or international normalized ratio (INR) =1.5.
- •10) Known hypersensitivity to hamster protein.
- •11) Any condition(s) that compromises the subject’s ability to comply with and/or perform study-related activities or that poses a clinical contraindication to study participation (these conditions include, but are not limited to, inadequate medical history available to assure study eligibility; inability to properly store study medication; expectation of poor compliance in study related documentation; poor venous access), in the opinion of the investigator.
- •12) Unwilling or unable to follow the terms of the protocol.
研究者
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A Non-Randomized, Open-Label Study to Evaluate the Pharmacokinetics, Safety, and Efficacy of ReFacto AF in Previously Treated Pediatric Subjects Less Than Twelve Years of Age With Severe Hemophilia A (FVIII:C <1%)Severe hemophilia A (FVIII:C <1%) in male subjects <12 years of age.MedDRA version: 9.1Level: LLTClassification code 10018937Term: Haemophilia AEUCTR2008-008435-29-CZWyeth Pharmaceuticals Inc. Acting through its division Wyeth Research, a Pfizer Company50
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A Non-Randomized, Open-Label Study to Evaluate the Pharmacokinetics, Safety, and Efficacy of ReFacto AF in Previously Treated Pediatric Subjects Less Than Twelve Years of Age With Severe Hemophilia A (FVIII:C <1%). - NDSevere hemophilia A (FVIII:C <1%) in male subjects <12 years of age.MedDRA version: 9.1Level: LLTClassification code 10018937EUCTR2008-008435-29-ITWyeth Research Division of Wyeth Pharmaceuticals Inc. Clinical Research & Development50
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The main purpose of this study is to gather information regarding the safety of ReFacto AF, and how well it works (effectiveness) in children with severe Hemophilia A under the age of 12. Approximately 50 subjects, will take part in this study. 25 subjects will be 0-6 years of age and 25 subjects will be 6 to 12 years of age.Severe hemophilia A (FVIII:C <1%) in male subjects <12 years of age.MedDRA version: 14.0Level: LLTClassification code 10018937Term: Haemophilia ASystem Organ Class: 10010331 - Congenital, familial and genetic disordersEUCTR2008-008435-29-FRWyeth Pharmaceuticals Inc. Acting through its division Wyeth Research, a Pfizer Company50
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The main purpose of this study is to gather information regarding the safety of ReFacto AF, and how well it works (effectiveness) in children with severe Hemophilia A under the age of 12. Approximately 50 subjects, will take part in this study. 25 subjects will be 0-6 years of age and 25 subjects will be 6 to 12 years of age.Severe hemophilia A (FVIII:C <1%) in male subjects <12 years of age.MedDRA version: 17.0Level: LLTClassification code 10018937Term: Haemophilia ASystem Organ Class: 100000004850EUCTR2008-008435-29-BGWyeth Pharmaceuticals Inc. Acting through its division Wyeth Research, a Pfizer Company50
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The main purpose of this study is to gather information regarding the safety of ReFacto AF, and how well it works (effectiveness) in children with severe Hemophilia A under the age of 12. Approximately 50 subjects, will take part in this study. 25 subjects will be 0-6 years of age and 25 subjects will be 6 to 12 years of age.Severe hemophilia A (FVIII:C <1%) in male subjects <12 years of age.MedDRA version: 14.1Level: LLTClassification code 10018937Term: Haemophilia ASystem Organ Class: 10010331 - Congenital, familial and genetic disordersEUCTR2008-008435-29-SEWyeth Pharmaceuticals Inc. Acting through its division Wyeth Research, a Pfizer Company50