NCT00157105已完成2 期
Recombinant Antihemophilic Factor (rAHF PFM) Manufactured and Formulated Without Added Human or Animal Proteins: Evaluation of Safety and Efficacy in Hemophilia A Patients Undergoing Surgical or Invasive Procedures
Baxalta now part of Shire19 个研究点 分布在 1 个国家目标入组 59 人开始时间: 2001年2月12日最近更新:
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 59
- 试验地点
- 19
- 主要终点
- Percent of participants experiencing treatment-related adverse experiences (AEs)
研究概览
简要总结
The purpose of this study is to evaluate whether rAHF-PFM is safe and effective in the treatment of hemophilia A patients undergoing surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 5 Years 至 —（Child, Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Age >= 5 years
- •The subject has severe or moderately severe hemophilia A defined by a baseline factor VIII level <= 2% of normal documented at screening or historically (e.g., at hemophilia diagnosis)
- •Subjects may enroll regardless of their serologic status for human immunodeficiency virus (HIV-1) and hepatitis C virus (HCV)
- •The subject requires a surgical, dental or other invasive procedure--either elective or emergency
- •The subject has a history of at least 150 exposure days for all other factor VIII products (as estimated by the study site investigator) prior to study entry
- •The subject has a life expectancy of at least 28 days from the day of surgery
- •The subject has been informed of the nature of the study, agreed to its provisions, and signed and dated the informed consent form approved by the appropriate IRB/IEC and Baxter BioScience
排除标准
- •The subject has a detectable inhibitor to factor VIII in the local hemostasis laboratory at the investigative site at the time of enrollment
- •The subject has a history of inhibitor to factor VIII > 1.0 BU. Note: If the subject has a history of an inhibitor titer > 1.0 BU at any time prior to enrollment but demonstrated expected clinical responses to conventional doses of factor VIII therapy, the subject may enroll
- •The subject has known hypersensitivity to Recombinate
- •The subject is currently participating in another investigational drug study, or has participated in any clinical trial involving an investigational drug within 30 days of study entry
- •The subject has clinical and/or laboratory evidence of abnormal hemostasis from causes other than hemophilia A (e.g., late-stage chronic liver disease, immune thrombocytopenic purpura, disseminated intravascular coagulation)
- •The subject is identified by the investigator as being unable or unwilling to cooperate with study procedures.
结局指标
主要结局
Percent of participants experiencing treatment-related adverse experiences (AEs)
时间窗: Throughout the study period of approximately 3.5 years
次要结局
未报告次要终点
研究者
研究点 (19)
Loading locations...
相似试验
已完成
2 期
Study of Pharmacokinetics, Efficacy, and Safety of a Recombinant and Protein-Free Factor VIII (rAHF-PFM) in Pediatric Patients With Hemophilia AHemophilia ANCT00157040Baxalta now part of Shire50
已完成
2 期
Efficacy and Safety Study of a Recombinant and Protein-Free Factor VIII (rAHF-PFM) in Pediatric Patients in Canada With Hemophilia A - A Continuation of Baxter Study 060101Hemophilia ANCT00189982Baxalta now part of Shire4
已完成
3 期
Efficacy and Safety Study of a Recombinant Protein-Free Manufactured Factor VIII (rAHF-PFM) in Previously Untreated Hemophilia A PatientsHemophilia ANCT00157157Baxalta now part of Shire66
已完成
2 期
Study of Pharmacokinetics, Efficacy and Safety of a Recombinant and Protein-Free Factor VIII (rAHF-PFM) in Hemophilia A Patients - A Continuation of Clinical Study 069901Hemophilia ANCT00157053Baxalta now part of Shire82
已完成
1 期
Pharmacokinetic Study of ADVATE Reconstituted in 2 mL Sterile Water for InjectionHemophilia ANCT00952822Baxalta now part of Shire52