protocolSection identificationModule nctId: NCT06297655, orgStudyIdInfo id: TQG202-III-01, briefTitle: A Clinical Study of Recombinant Human Coagulation Factor VIII for Injection in Patients With Severe Hemophilia A, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2025-04, completionDateStruct date: 2025-04, studyFirstPostDateStruct date: 2024-03-07, lastUpdatePostDateStruct date: 2024-03-07, sponsorCollaboratorsModule leadSponsor name: Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd., class: INDUSTRY, descriptionModule 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., conditionsModule conditions: Hemophilia A, designModule studyType: INTERVENTIONAL, phases: PHASE3, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 60, type: ESTIMATED, armsInterventionsModule interventions name: Recombinant human activated coagulation factor VIII for injection, outcomesModule primaryOutcomes measure: The proportion of on-demand treatment improvement for newly occurring bleeding events, primaryOutcomes measure: Activity recovery, secondaryOutcomes measure: The proportion of effective surgical hemostasis, secondaryOutcomes measure: Annualized bleeding rate (ABR), secondaryOutcomes measure: The incidence of Less Han Expected Thermal Effect, secondaryOutcomes measure: The injection times of recombinant human coagulation factor VIII, secondaryOutcomes measure: The dosage of recombinant human coagulation factor VIII, secondaryOutcomes measure: Changes of Haemophilia Joint Health Score before and after on-demand treatment, secondaryOutcomes measure: Changes of Quality of Life Assessment before and after on-demand treatment, eligibilityModule sex: ALL, minimumAge: 12 Years, maximumAge: 65 Years, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Anhui Provincial Hospital, city: Hefei, state: Anhui, zip: 230002, country: China, contacts name: Juan Tong, Doctor, role: CONTACT, phone: 13955114442, email: tongj5200@163.com, geoPoint lat: 31.86389, lon: 117.28083, locations facility: The Second Affiliated Hospital of Chongqing Medical University, city: Chongqing, state: Chongqing, zip: 400010, country: China, contacts name: Shu Chen, Master, role: CONTACT, phone: 13983420188, email: chenshu921@163.com, geoPoint lat: 29.56278, lon: 106.55278, locations facility: The First Hospital of Lanzhou University, city: Lanzhou, state: Gansu, zip: 730013, country: China, contacts name: Yaming Xi, Doctor, role: CONTACT, phone: 13919110815, email: xiyaming02@163.com, geoPoint lat: 36.05701, lon: 103.83987, locations facility: Nanfang Hospital, Southern Medical University, city: Guangzhou, state: Guangdong, zip: 510515, country: China, contacts name: Jing Sun, Doctor, role: CONTACT, phone: 13316202696, email: jsun-cn@qq.com, geoPoint lat: 23.11667, lon: 113.25, locations facility: The First Affiliated Hospital of Guangxi Medical University, city: Nanning, state: Guangxi, zip: 530021, country: China, contacts name: Peng Cheng, Master, role: CONTACT, phone: 13977166448, email: 13977166448@163.com, geoPoint lat: 22.81667, lon: 108.31667, locations facility: Henan Tumor Hospital, city: Zhengzhou, state: Henan, zip: 450003, country: China, contacts name: Hu Zhou, Doctor, role: CONTACT, phone: 13939068863, email: papertigerhu@163.com, geoPoint lat: 34.75778, lon: 113.64861, locations facility: Xiangya Hospital Central South University, city: Changsha, state: Hunan, zip: 410008, country: China, contacts name: Jie Peng, Doctor, role: CONTACT, phone: 13974802938, email: pengjie-0728@163.com, geoPoint lat: 28.19874, lon: 112.97087, locations facility: Nanjing Drug Tower Hospital, city: Nanjing, state: Jiangsu, zip: 210008, country: China, contacts name: Rongfu Zhou, Doctor, role: CONTACT, phone: 13605142342, email: rfzhoucn@163.com, geoPoint lat: 32.06167, lon: 118.77778, locations facility: Jiangxi Provincial People's Hospital, city: Nanchang, state: Jiangxi, zip: 330006, country: China, contacts name: Chenghao Jin, Doctor, role: CONTACT, phone: 13699500207, email: Jinch227@aliyun.com, geoPoint lat: 28.68396, lon: 115.85306, locations facility: Hematology Hospital of Chinese Academy of Medical Sciences, city: Tianjin, state: Tianjin, zip: 300020, country: China, contacts name: Lei Zhang, Doctor, role: CONTACT, phone: 13502118379, email: zhanglei1@ihcams.ac.cn, geoPoint lat: 39.14222, lon: 117.17667, locations facility: The Second Affiliated Hospital of Kunming Medical University, city: Kunming, state: Yunnan, zip: 650106, country: China, contacts name: Zeping Zhou, Doctor, role: CONTACT, phone: 18788571605, email: 18788571605@163.com, geoPoint lat: 25.03889, lon: 102.71833, hasResults: False