A Postauthorization Safety Surveillance Study Of Xyntha In Usual Care Settings
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 发起方
- Pfizer
- 入组人数
- 12
- 试验地点
- 7
- 主要终点
- Percentage of Participants With Factor VIII (FVIII) Inhibitor Development
研究概览
简要总结
The purpose of this study is to collect safety information associated with the use of Xyntha in a usual care setting. Upon meeting eligibility criteria, patients will be required to have approximately 5 study visits over a 2 year period. Procedures completed throughout the study include collection of vital signs, physical exams, and laboratory assessments. Patients will be required to complete an infusion log for each Xyntha infusion.
详细描述
The study was terminated on May 12, 2011 due to poor enrollment prospects and the study's similarity to another ongoing trial with ReFacto AF.
The termination of this study has no impact on subject safety or well being. The decision to terminate the trial was not based on any safety concerns.
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
- 12 Years 至 —（Child, Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Male patients 12 years of age and older.
- •Patients transitioned to Xyntha from other recombinant or plasma-derived FVIII replacement products.
- •Treatment history of 150 or greater exposure days to any FVIII products prior to Enrollment visit.
- •Negative inhibitor at screening or documentation of negative inhibitor titer within 6 weeks or less prior to study entry except for patients entering the study on immune tolerance induction therapy.
排除标准
- •Bleeding disorder other than hemophilia A.
- •Inhibitor titer greater than or equal to 0.6 BU during screening except for patients on immune tolerance induction therapy.
- •Immunomodulatory therapy during screening period.
- •Known hypersensitivity to hamster protein.
研究组 & 干预措施
Moroctocog alfa(AF-CC)
干预措施: Moroctocog alfa(AF-CC) (Biological)
Moroctocog alfa(AF-CC)
干预措施: Blood draw for laboratory testing (Procedure)
结局指标
主要结局
Percentage of Participants With Factor VIII (FVIII) Inhibitor Development
时间窗: Month 24 or early withdrawal
FVIII inhibitor development was defined as an inhibitor titer of more than or equal to 0.6 Bethesda Units (BU) using the Nijmegen modification of the Bethesda assay and confirmed by the central laboratory.
次要结局
未报告次要终点