ISRCTN58752772进行中（未招募）未知
on-interventional study to investigate the effectiveness of emicizumab under real-world conditions in pediatric, adolescent, adult and elderly patients with hemophilia A with and without FVIII inhibitors
Roche (Germany)0 个研究点目标入组 168 人开始时间: 2022年2月9日最近更新:
试验速览
- 阶段
- 未知
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 168
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational
入排标准
- 性别
- Male
入选标准
- •1. Participants of any age with congenital severe haemophilia A with or without FVIII inhibitors
- •2. Participants undergoing treatment with emicizumab according to Summary of Product Characteristics (SPC) (start of treatment with emicizumab maximum 3 months prior to study entry)
- •3. Must sign informed consent by the legal representative or participant or both, as required
- •4. Selection criteria for Cohort A include participants diagnosed with severe congenital haemophilia A (<1% FVIII activity) and no present FVIII inhibitor at the start of emicizumab treatment, patients who completed successful ITI before the start of Emicizumab treatment are eligible.
- •5. Selection criteria for Cohort B include participants diagnosed with congenital haemophilia A (any severity) with FVIII inhibitor activity at the start of emicizumab treatment or ongoing ITI at the start of emicizumab treatment
排除标准
- •1. Participants having bleeding disorder other than congenital haemophilia A
- •2. Treatment with emicizumab outside of the SPC at study entry
- •3. Any contraindication for treatment with emicizumab according to current SPC
- •4. Current participation in an interventional study
研究者
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