Condition: Severe Hemophilia A · Sponsor: Hangzhou Gensciences Biopharmaceutical Co., Ltd.
The indication for this product is to control bleeding in patients with hemophilia A (congenital deficiency of factor VIII). The primary objective: Evaluation of the efficacy of recombinant human coagulation factor VIII-Fc fusion protein for injection (FRSW107) as an on-demand treatment in previously treated patients with severe hemophilia A. Secondary objectives: Evaluation of the safety and immunogenicity of FRSW107 as an on-demand therapy in previously treated patients with severe hemophilia A. Evaluate the on-demand treatment's PK profile of FRSW107 in previously treated patients with severe hemophilia A based on population pharmacokinetic (PopPK) methods ; preliminarily investigate the exposure-response (E-R) relationship of FRSW107 on-demand treatment in these patients if data permit.
This description comes directly from the study's public registry record.
Lijia Liu · + 86 1645377793 · lijialiu@gensciences.cn
Always discuss trial participation with your own doctor first.
| Institute of Hematology & Blood Diseases Hospital Chinese Academy of Medical Sciences & Peking Union Medical College | Tianjin, Tianjin Municipality, China | Recruiting |
| Fuyang Hospital, Affiliated to Anhui Medical University | Fuyang, China | Not Yet Recruiting |
| Fujian Medical University Union Hospital | Fuzhou, China | Not Yet Recruiting |
| Ganzhou People's Hospital | Ganzhou, China | Not Yet Recruiting |
| Nanfang Hospital of Southern Medical University | Guangzhou, China | Not Yet Recruiting |
| Anhui Provincial Hospital | Hefei, China | Not Yet Recruiting |
| Huai'an Second People's Hospital | Huai'an, China | Not Yet Recruiting |
| Jinan central hospital | Jinan, China | Not Yet Recruiting |
| The Second Affiliated Hospital of Kunming Medical University | Kunming, China | Not Yet Recruiting |
| The First Affiliated Hospital of Guangxi Medical University | Nanning, China | Not Yet Recruiting |
| Affiliated Hospital of Nantong University | Nantong, China | Not Yet Recruiting |
| The First Affiliated Hospital of Nanyang Medical College | Nanyang, China | Not Yet Recruiting |
+ 12 more locations — full list on the registry record.
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Source record: clinicaltrials.gov/study/NCT07663903