An Open-Label, Multicenter Evaluation of the Long-Term Safety and Efficacy of Recombinant Human Coagulation Factor VIII Fusion Protein (rFVIIIFc) in the Prevention and Treatment of Bleeding Episodes in Previously Treated Subjects With Hemophilia A
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 194
- 试验地点
- 5
- 主要终点
- •Number of hospitalizations, excluding planned hospitalizations, elective surgery documented at Visit 1, and emergent surgery
研究概览
简要总结
8HA01EXT is an extension study designed to assess the long-term safety and efficacy of recombinant factor VIII fusion (rFVIIIFc) in previously treated subjects with hemophilia A. Male subjects of all ages who have completed the preceding study of rFVIIIFc (997HA301 [A‑LONG]) may be eligible for enrollment in this study.xml:namespace prefix = o ns = "urn:schemas-microsoft-com:office:office" /
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Not Applicable
入排标准
- 年龄范围
- 18.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- Male
入选标准
- •1.Ability to understand the purpose and risks of the study and provide signed and dated informed consent and authorization to use protected health information (PHI) in accordance with national and local subject privacy regulations.
- •Parental or guardian consent is required for subjects who are less than 18 years of age or unable to give consent, or as applicable per local laws.
- •2.Subjects who have completed Study 997HA301.
排除标准
- •1.Confirmed positive high-titer inhibitor test (≥5.00 BU/mL) 2.Medical or other reasons that, in the opinion of the Investigator, make the subject unsuitable for enrollment.
结局指标
主要结局
•Number of hospitalizations, excluding planned hospitalizations, elective surgery documented at Visit 1, and emergent surgery
时间窗: •Number of hospitalizations, excluding planned hospitalizations, elective surgery documented at Visit 1, and emergent surgery | •Number of emergency room visits | •Number of physician visits, excluding study visits | •Number of hospitalization days | •Number of days off work or school | •Number of days off work for a parent/caregiver (demographic data for parents/caregivers will be collected at Visit 1)
•Number of emergency room visits
时间窗: •Number of hospitalizations, excluding planned hospitalizations, elective surgery documented at Visit 1, and emergent surgery | •Number of emergency room visits | •Number of physician visits, excluding study visits | •Number of hospitalization days | •Number of days off work or school | •Number of days off work for a parent/caregiver (demographic data for parents/caregivers will be collected at Visit 1)
•Number of physician visits, excluding study visits
时间窗: •Number of hospitalizations, excluding planned hospitalizations, elective surgery documented at Visit 1, and emergent surgery | •Number of emergency room visits | •Number of physician visits, excluding study visits | •Number of hospitalization days | •Number of days off work or school | •Number of days off work for a parent/caregiver (demographic data for parents/caregivers will be collected at Visit 1)
•Number of hospitalization days
时间窗: •Number of hospitalizations, excluding planned hospitalizations, elective surgery documented at Visit 1, and emergent surgery | •Number of emergency room visits | •Number of physician visits, excluding study visits | •Number of hospitalization days | •Number of days off work or school | •Number of days off work for a parent/caregiver (demographic data for parents/caregivers will be collected at Visit 1)
•Number of days off work or school
时间窗: •Number of hospitalizations, excluding planned hospitalizations, elective surgery documented at Visit 1, and emergent surgery | •Number of emergency room visits | •Number of physician visits, excluding study visits | •Number of hospitalization days | •Number of days off work or school | •Number of days off work for a parent/caregiver (demographic data for parents/caregivers will be collected at Visit 1)
•Number of days off work for a parent/caregiver (demographic data for parents/caregivers will be collected at Visit 1)
时间窗: •Number of hospitalizations, excluding planned hospitalizations, elective surgery documented at Visit 1, and emergent surgery | •Number of emergency room visits | •Number of physician visits, excluding study visits | •Number of hospitalization days | •Number of days off work or school | •Number of days off work for a parent/caregiver (demographic data for parents/caregivers will be collected at Visit 1)
次要结局
- The secondary objective of the study is to evaluate the efficacy of rFVIIIFc in the prevention and treatment of bleeding episodes in subjects with hemophilia A.(The number of annualized bleeding episodes (spontaneous and traumatic) per subject)