ArticleNature medicine2026
Factor IX Padua AAV gene therapy in adolescents with hemophilia B: a phase 1 trial.
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Authors and funding
23 authors.
Feng Xue *State Key Laboratory of Experimental Hematology, National Clinical Research Centre for Blood Diseases, Haihe Laboratory of Cell Ecosystem, Tianjin Key Laboratory of Gene Therapy for Blood Diseases, CAMS Key Laboratory of Gene Therapy for Blood Diseases, Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, Tianjin, China.ORCID http://orcid.org/0000-0002-5947-3924
Ai Zhang *Tongji Hospital affiliated to Tongji Medical College of Huazhong University of Science & Technology, Wuhan, China.
Mankai Ju *State Key Laboratory of Experimental Hematology, National Clinical Research Centre for Blood Diseases, Haihe Laboratory of Cell Ecosystem, Tianjin Key Laboratory of Gene Therapy for Blood Diseases, CAMS Key Laboratory of Gene Therapy for Blood Diseases, Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, Tianjin, China.ORCID http://orcid.org/0000-0002-3570-8389
Xia Wu *East China University of Science and Technology, Shanghai, China.
Bingqi Xu *State Key Laboratory of Experimental Hematology, National Clinical Research Centre for Blood Diseases, Haihe Laboratory of Cell Ecosystem, Tianjin Key Laboratory of Gene Therapy for Blood Diseases, CAMS Key Laboratory of Gene Therapy for Blood Diseases, Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, Tianjin, China.
Xiaolei PeiState Key Laboratory of Experimental Hematology, National Clinical Research Centre for Blood Diseases, Haihe Laboratory of Cell Ecosystem, Tianjin Key Laboratory of Gene Therapy for Blood Diseases, CAMS Key Laboratory of Gene Therapy for Blood Diseases, Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, Tianjin, China.
Yuhua WangState Key Laboratory of Experimental Hematology, National Clinical Research Centre for Blood Diseases, Haihe Laboratory of Cell Ecosystem, Tianjin Key Laboratory of Gene Therapy for Blood Diseases, CAMS Key Laboratory of Gene Therapy for Blood Diseases, Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, Tianjin, China.
Wei LiuState Key Laboratory of Experimental Hematology, National Clinical Research Centre for Blood Diseases, Haihe Laboratory of Cell Ecosystem, Tianjin Key Laboratory of Gene Therapy for Blood Diseases, CAMS Key Laboratory of Gene Therapy for Blood Diseases, Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, Tianjin, China.ORCID http://orcid.org/0000-0003-4713-2441
Aiguo LiuTongji Hospital affiliated to Tongji Medical College of Huazhong University of Science & Technology, Wuhan, China.
Wei JiangBelief BioMed Inc., Shanghai, China.
Xinyue DaiState Key Laboratory of Experimental Hematology, National Clinical Research Centre for Blood Diseases, Haihe Laboratory of Cell Ecosystem, Tianjin Key Laboratory of Gene Therapy for Blood Diseases, CAMS Key Laboratory of Gene Therapy for Blood Diseases, Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, Tianjin, China.
Yunfei ChenState Key Laboratory of Experimental Hematology, National Clinical Research Centre for Blood Diseases, Haihe Laboratory of Cell Ecosystem, Tianjin Key Laboratory of Gene Therapy for Blood Diseases, CAMS Key Laboratory of Gene Therapy for Blood Diseases, Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, Tianjin, China.ORCID http://orcid.org/0000-0001-7309-8545
Xiaofan LiuState Key Laboratory of Experimental Hematology, National Clinical Research Centre for Blood Diseases, Haihe Laboratory of Cell Ecosystem, Tianjin Key Laboratory of Gene Therapy for Blood Diseases, CAMS Key Laboratory of Gene Therapy for Blood Diseases, Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, Tianjin, China.
Rongfeng FuState Key Laboratory of Experimental Hematology, National Clinical Research Centre for Blood Diseases, Haihe Laboratory of Cell Ecosystem, Tianjin Key Laboratory of Gene Therapy for Blood Diseases, CAMS Key Laboratory of Gene Therapy for Blood Diseases, Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, Tianjin, China.ORCID http://orcid.org/0000-0001-5442-1028
Ting SunState Key Laboratory of Experimental Hematology, National Clinical Research Centre for Blood Diseases, Haihe Laboratory of Cell Ecosystem, Tianjin Key Laboratory of Gene Therapy for Blood Diseases, CAMS Key Laboratory of Gene Therapy for Blood Diseases, Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, Tianjin, China.
Wenjing GuState Key Laboratory of Experimental Hematology, National Clinical Research Centre for Blood Diseases, Haihe Laboratory of Cell Ecosystem, Tianjin Key Laboratory of Gene Therapy for Blood Diseases, CAMS Key Laboratory of Gene Therapy for Blood Diseases, Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, Tianjin, China.
Jing ZhengBelief BioMed Inc., Shanghai, China.
Zengmin DuBelief BioMed Inc., Shanghai, China.
Caifeng YangBelief BioMed Inc., Shanghai, China.
Xiao XiaoEast China University of Science and Technology, Shanghai, China. xiaoxiao@beliefbiomed.cn.ORCID http://orcid.org/0009-0002-2975-5725
Renchi YangState Key Laboratory of Experimental Hematology, National Clinical Research Centre for Blood Diseases, Haihe Laboratory of Cell Ecosystem, Tianjin Key Laboratory of Gene Therapy for Blood Diseases, CAMS Key Laboratory of Gene Therapy for Blood Diseases, Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, Tianjin, China. rcyang@ihcams.ac.cn.ORCID http://orcid.org/0000-0003-3741-8518
Qun HuTongji Hospital affiliated to Tongji Medical College of Huazhong University of Science & Technology, Wuhan, China. qunhu2013@163.com.ORCID http://orcid.org/0000-0002-1508-2796
Lei ZhangState Key Laboratory of Experimental Hematology, National Clinical Research Centre for Blood Diseases, Haihe Laboratory of Cell Ecosystem, Tianjin Key Laboratory of Gene Therapy for Blood Diseases, CAMS Key Laboratory of Gene Therapy for Blood Diseases, Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, Tianjin, China. zhanglei1@ihcams.ac.cn.ORCID http://orcid.org/0000-0001-7769-7377
Funding
No grant is acknowledged in the PubMed record.
Abstract
Adeno-associated virus (AAV)-mediated factor IX Padua gene therapy has demonstrated good safety and efficacy in adult patients with hemophilia B, but its safety and efficacy in adolescent patients with hemophilia B remain unknown. Here we report a multicenter, single-arm, phase 1 study involving 11 adolescent participants (aged 12-18 years) with severe or moderately severe hemophilia B (factor IX coagulant activity (FIX:C) ≤2 IU dl
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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.