EUCTR2008-008435-29-IT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%). - ND
Wyeth Research Division of Wyeth Pharmaceuticals Inc. Clinical Research & Development0 个研究点目标入组 50 人开始时间: 2009年10月2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/?L. 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 subjects 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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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
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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-GRWyeth Research Division of Wyeth Pharmaceuticals Inc. Clinical Research and Development50