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正在招募II 期 / III 期编号 NCT06111638
Evaluation of the Safety and Efficacy of Hemophilia A Gene Therapy Drugs
报名条件(概要)
- 年龄:18 Years – 不限
- 性别:男性
- 健康志愿者:不接受
完整入排标准请以官方页面为准。
开展国家/地区
China
研究药物 / 干预措施
Single dose intravenous injection of BBM-H803
申办方
Shanghai Xinzhi BioMed Co., Ltd.
研究简介(原文)
This is a multi-center, Phase 1/2/3, single-arm, open-label, single-dose treatment clinical study to evaluate the safety, tolerability and efficacy of BBM-H803 injection in severe Hemophilia A subjects. BBM-H803 is an adeno-associated viral (AAV) vector derived from recombinant DNA techniques to contain an expression cassette of the human factor VIII transgene and raises circulating levels of endogenous FVIII.
适应症
Hemophilia A
主动联系研究团队
总联系人(申办方/研究总部)
- Wenqi Shao, Masterra@beliefbiomed.com13636317441
中国/港澳台研究中心
- Peking Union Medical College Hospital, Chinese Academy of Medical SciencesBeijing,Beijing Municipality,China
- Southern Hospital, Southern Medical UniversityGuangzhou,Guangdong,China
- Affiliated Hospital of Guizhou Medical UniversityGuiyang,Guizhou,China
- Wuhan Union Hospital Affiliated to Huazhong University of Science and TechnologyWuhan,Hubei,China
- Xiangya Hospital Central South UniversityChangsha,Hunan,China
- The First Affiliated Hospital of Soochow UniversitySuzhou,Jiangsu,China
问自己是否符合条件、如何预筛
我的病情档案
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英文版(发给研究团队)
Dear Study Team, I am a patient in China and I am interested in participating in your clinical trial: Study Title: Evaluation of the Safety and Efficacy of Hemophilia A Gene Therapy Drugs ClinicalTrials.gov Identifier: NCT06111638 Sponsor: Shanghai Xinzhi BioMed Co., Ltd. Investigational product: Single dose intravenous injection of BBM-H803 About me: - Age: (please fill in) - Sex: (please fill in) - Confirmed diagnosis and stage: (please fill in) - Biomarkers / genetic testing: not available - Prior and current treatments: (please fill in) - Performance status (ECOG): not assessed - Current location: China - Travel ability: (please fill in) Could you please let me know: 1. Whether I might be eligible for this study; 2. Which site would be closest and most practical for me, and whether remote pre-screening is possible; 3. What documents (medical records, pathology or imaging reports, recent labs) I should prepare for pre-screening. I can provide English translations of my medical records. Thank you very much for your time and help. Kind regards, (your name) (your email / phone with country code)
中文对照(供您核对)
尊敬的研究团队: 我是一位来自中国的患者,希望咨询参加以下临床试验的可能: 研究名称:Evaluation of the Safety and Efficacy of Hemophilia A Gene Therapy Drugs 试验编号:NCT06111638 申办方:Shanghai Xinzhi BioMed Co., Ltd. 研究药物:Single dose intravenous injection of BBM-H803 我的基本情况: - 年龄:(请填写) - 性别:(请填写) - 确诊疾病与分期:(请填写) - 基因/标志物检测:暂无 - 既往及当前治疗:(请填写) - 体能状态(ECOG):未评估 - 目前所在城市:中国 - 可前往范围:(请填写) 想请教三个问题: 1. 我是否可能符合本研究的入组标准? 2. 哪个中心对我最方便可行?能否远程预筛? 3. 预筛需要准备哪些资料(病历、病理、影像、近期化验)? 我可以提供英文翻译版病历。感谢您的时间与帮助。 顺祝安康 (您的姓名) (您的邮箱/带国际区号的电话)
提示:请与主治医生一起发信——由医生署名的申请,回复率远高于患者单独发信。首封邮件不要附身份证号等敏感信息。研究团队通常在 3–10 个工作日内回复,两周无回音可礼貌追问一次。
下一步怎么做?
- 把本页信息带给您的主治医生,评估是否适合参加。
- 点击下方按钮打开官方注册页,查看研究中心联系方式。
- 直接联系研究团队咨询报名事宜(通常有中文同声翻译服务可协助沟通)。