nctId: NCT06297655 id: TQG202-III-01 briefTitle: A Clinical Study of Recombinant Human Coagulation Factor VIII for Injection in Patients With Severe Hemophilia A overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2025-04 date: 2025-04 date: 2024-03-07 date: 2024-03-07 name: Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd. class: INDUSTRY briefSummary: This study is a single arm, open, multicenter clinical trial in which the previous treated severe hemophilia A patients receive recombinant human coagulation factor VIII for injection to evaluate the efficacy and safety of on-demand treatment in the event of new bleeding events. If evaluable surgical cases occur, the overall efficacy and safety of recombinant human coagulation factor VIII for injection as a replacement therapy for severe hemophilia A PTPs during the perioperative period will be evaluated. conditions: Hemophilia A studyType: INTERVENTIONAL phases: PHASE3 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 60 type: ESTIMATED name: Recombinant human activated coagulation factor VIII for injection measure: The proportion of on-demand treatment improvement for newly occurring bleeding events measure: Activity recovery measure: The proportion of effective surgical hemostasis measure: Annualized bleeding rate (ABR) measure: The incidence of Less Han Expected Thermal Effect measure: The injection times of recombinant human coagulation factor VIII measure: The dosage of recombinant human coagulation factor VIII measure: Changes of Haemophilia Joint Health Score before and after on-demand treatment measure: Changes of Quality of Life Assessment before and after on-demand treatment sex: ALL minimumAge: 12 Years maximumAge: 65 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Anhui Provincial Hospital city: Hefei state: Anhui zip: 230002 country: China name: Juan Tong, Doctor role: CONTACT phone: 13955114442 email: tongj5200@163.com lat: 31.86389 lon: 117.28083 facility: The Second Affiliated Hospital of Chongqing Medical University city: Chongqing state: Chongqing zip: 400010 country: China name: Shu Chen, Master role: CONTACT phone: 13983420188 email: chenshu921@163.com lat: 29.56278 lon: 106.55278 facility: The First Hospital of Lanzhou University city: Lanzhou state: Gansu zip: 730013 country: China name: Yaming Xi, Doctor role: CONTACT phone: 13919110815 email: xiyaming02@163.com lat: 36.05701 lon: 103.83987 facility: Nanfang Hospital, Southern Medical University city: Guangzhou state: Guangdong zip: 510515 country: China name: Jing Sun, Doctor role: CONTACT phone: 13316202696 email: jsun-cn@qq.com lat: 23.11667 lon: 113.25 facility: The First Affiliated Hospital of Guangxi Medical University city: Nanning state: Guangxi zip: 530021 country: China name: Peng Cheng, Master role: CONTACT phone: 13977166448 email: 13977166448@163.com lat: 22.81667 lon: 108.31667 facility: Henan Tumor Hospital city: Zhengzhou state: Henan zip: 450003 country: China name: Hu Zhou, Doctor role: CONTACT phone: 13939068863 email: papertigerhu@163.com lat: 34.75778 lon: 113.64861 facility: Xiangya Hospital Central South University city: Changsha state: Hunan zip: 410008 country: China name: Jie Peng, Doctor role: CONTACT phone: 13974802938 email: pengjie-0728@163.com lat: 28.19874 lon: 112.97087 facility: Nanjing Drug Tower Hospital city: Nanjing state: Jiangsu zip: 210008 country: China name: Rongfu Zhou, Doctor role: CONTACT phone: 13605142342 email: rfzhoucn@163.com lat: 32.06167 lon: 118.77778 facility: Jiangxi Provincial People's Hospital city: Nanchang state: Jiangxi zip: 330006 country: China name: Chenghao Jin, Doctor role: CONTACT phone: 13699500207 email: Jinch227@aliyun.com lat: 28.68396 lon: 115.85306 facility: Hematology Hospital of Chinese Academy of Medical Sciences city: Tianjin state: Tianjin zip: 300020 country: China name: Lei Zhang, Doctor role: CONTACT phone: 13502118379 email: zhanglei1@ihcams.ac.cn lat: 39.14222 lon: 117.17667 facility: The Second Affiliated Hospital of Kunming Medical University city: Kunming state: Yunnan zip: 650106 country: China name: Zeping Zhou, Doctor role: CONTACT phone: 18788571605 email: 18788571605@163.com lat: 25.03889 lon: 102.71833 hasResults: False