protocolSection identificationModule nctId: NCT06289166, orgStudyIdInfo id: STSP-0601-04, briefTitle: Safety and Efficacy of STSP-0601 in Adult Patients With Hemophilia A or B With Inhibitor, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-18, primaryCompletionDateStruct date: 2025-02, completionDateStruct date: 2025-02, studyFirstPostDateStruct date: 2024-03-01, lastUpdatePostDateStruct date: 2024-04-03, sponsorCollaboratorsModule leadSponsor name: Staidson (Beijing) Biopharmaceuticals Co., Ltd, class: INDUSTRY, descriptionModule briefSummary: This study will assess the safety and efficacy of multiple-dose of STSP-0601 for the treatment of bleeding episodes in hemophilia A or B patients with inhibitor., conditionsModule conditions: Hemophilia, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: NA, interventionModel: SEQUENTIAL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 25, type: ESTIMATED, armsInterventionsModule interventions name: STSP-0601 for Injection, outcomesModule primaryOutcomes measure: Incidence of adverse events, primaryOutcomes measure: Proportion of successfully treated bleeding episodes, secondaryOutcomes measure: Proportion of successfully treated bleeding episodes, secondaryOutcomes measure: Proportion of bleeding episodes received salvage treatment, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 70 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Anhui Provincial Hospital, status: NOT_YET_RECRUITING, city: Hefei, state: Anhui, zip: 230000, country: China, contacts name: Changcheng Zheng, role: CONTACT, phone: 13956961162, email: zhengchch1123@163.com, geoPoint lat: 31.86389, lon: 117.28083, locations facility: The Second Affiliated Hospital of Chongqing Medical University, status: NOT_YET_RECRUITING, city: Chongqing, state: Chongqing, zip: 400000, country: China, contacts name: Shu Chen, role: CONTACT, phone: 13983420188, email: chenshu921@163.com, geoPoint lat: 29.56278, lon: 106.55278, locations facility: Fujian Medical University Affiliated Union Medical College Hospital, status: NOT_YET_RECRUITING, city: Fuzhou, state: Fujian, zip: 350005, country: China, contacts name: Fenge Yang, role: CONTACT, phone: 13635250168, email: 339694677@qq.com, geoPoint lat: 26.06139, lon: 119.30611, locations facility: Lanzhou University First Hospital, status: NOT_YET_RECRUITING, city: Lanzhou, state: Gansu, zip: 730000, country: China, contacts name: Yaming Xi, role: CONTACT, phone: 13919110815, email: ncuyfygcp2018@163.com, geoPoint lat: 36.05701, lon: 103.83987, locations facility: Southern Medical University Southern Hospital, status: NOT_YET_RECRUITING, city: Guangzhou, state: Guangdong, zip: 510000, country: China, contacts name: Jing Sun, role: CONTACT, phone: 13316202696, email: jsun-cn@qq.com, geoPoint lat: 23.11667, lon: 113.25, locations facility: Shenzhen Second People's Hospital, status: NOT_YET_RECRUITING, city: Shenzhen, state: Guangdong, zip: 518000, country: China, contacts name: Xin Du, role: CONTACT, phone: 13602523722, email: duxingz@medmail.com.cn, geoPoint lat: 22.54554, lon: 114.0683, locations facility: Guizhou Medical University Affiliated Hospital, status: NOT_YET_RECRUITING, city: Guiyang, state: Guizhou, zip: 550000, country: China, contacts name: Jishi Wang, role: CONTACT, phone: 13312233711, email: wjiayu1399@163.com, geoPoint lat: 26.58333, lon: 106.71667, locations facility: Harbin First Hospital Hematology Tumor Research Center, status: NOT_YET_RECRUITING, city: Harbin, state: Heilongjiang, zip: 150000, country: China, contacts name: Jun Ma, role: CONTACT, phone: 0451-84883471, geoPoint lat: 45.75, lon: 126.65, locations facility: Henan Cancer Hospital, status: NOT_YET_RECRUITING, city: Zhengzhou, state: Henan, zip: 450000, country: China, contacts name: Hu Zhou, role: CONTACT, phone: 13939068863, email: papertigerhu@163.com, geoPoint lat: 34.75778, lon: 113.64861, locations facility: Xiangya Hospital of Central South University, status: NOT_YET_RECRUITING, city: Changsha, state: Hunan, zip: 410000, country: China, contacts name: Jie Peng, role: CONTACT, phone: 13974802938, email: pengjie-0728@csu.edu.cn, geoPoint lat: 28.19874, lon: 112.97087, locations facility: Nanjing University School of Medicine Affiliated Gulou Hospital, status: NOT_YET_RECRUITING, city: Nanjing, state: Jiangsu, zip: 210000, country: China, contacts name: Rongfu Zhou, role: CONTACT, phone: 13605142342, email: rfzhoucn@163.com, geoPoint lat: 32.06167, lon: 118.77778, locations facility: The First Affiliated Hospital of Nanchang University, status: NOT_YET_RECRUITING, city: Nanchang, state: Jiangxi, zip: 330038, country: China, contacts name: Ruibin Huang, role: CONTACT, phone: 13970006820, email: rbhuang69@163.com, geoPoint lat: 28.68396, lon: 115.85306, locations facility: The first hospital of Jilin University, status: NOT_YET_RECRUITING, city: Changchun, state: Jilin, zip: 130000, country: China, contacts name: Sujun Gao, role: CONTACT, phone: 158430732085, email: sujung1963@163.com, geoPoint lat: 43.88, lon: 125.32278, locations facility: Shengjing Hospital Affiliated to China Medical University, status: NOT_YET_RECRUITING, city: Shenyang, state: Liaoning, zip: 110000, country: China, contacts name: Wei Yang, role: CONTACT, phone: 18940259033, email: yangw@sj-hospital.org, geoPoint lat: 41.79222, lon: 123.43278, locations facility: Affiliated Hospital of Qingdao University, status: NOT_YET_RECRUITING, city: Qingdao, state: Shandong, zip: 266000, country: China, contacts name: Zhongguang Cui, role: CONTACT, phone: 18661809137, email: cuizhguang@163.com, geoPoint lat: 36.06488, lon: 120.38042, locations facility: Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine, status: NOT_YET_RECRUITING, city: Shanghai, state: Shanghai, zip: 200000, country: China, contacts name: Xuefeng Wang, role: CONTACT, phone: 18917762601, email: 13641653074@139.com, geoPoint lat: 31.22222, lon: 121.45806, locations facility: Xi'an Central Hospital, status: NOT_YET_RECRUITING, city: Xi'an, state: Shanxi, zip: 710000, country: China, contacts name: Yanping Song, role: CONTACT, phone: 13572973308, email: xjtusyp@163.com, geoPoint lat: 34.25833, lon: 108.92861, locations facility: West China Hospital of Sichuan University, status: NOT_YET_RECRUITING, city: Chengdu, state: Sichuan, zip: 610000, country: China, contacts name: Yuping Gong, role: CONTACT, phone: 15680990805, email: Liy1905@sina.com, geoPoint lat: 30.66667, lon: 104.06667, locations facility: Hospital of Hematology, Chinese Academy of Medical Sciences, status: RECRUITING, city: Tianjin, state: Tianjin, zip: 300020, country: China, contacts name: Lei Zhang, role: CONTACT, phone: 022-23909095, email: zhanglei1@ihcams.ac.cn, geoPoint lat: 39.14222, lon: 117.17667, locations facility: The Second Affiliated Hospital of Kunming Medical University, status: NOT_YET_RECRUITING, city: Kunming, state: Yunnan, zip: 650000, country: China, contacts name: Zeping Zhou, role: CONTACT, phone: 18788571605, email: zhouzeping@kmmu.edu.cn, geoPoint lat: 25.03889, lon: 102.71833, hasResults: False