Takeda
The main aim of the study is to determine how well Adynovate works to decrease bleeding in previously treated Chinese men and boys with severe hemophilia A when given prophylactically. Participants will be treated with Adynovate twice a week for 26 weeks or until participants have received 50 days of treatment with Adynovate (whichever takes longer). Participants will need to visit their study clinic several times during their participation.
Hemophilia A
Adynovate
Phase 3
Study Type : | Interventional |
Estimated Enrollment : | 37 participants |
Masking : | None (Open Label) |
Primary Purpose : | Treatment |
Official Title : | A Phase 3, Prospective, Multicenter, Open-label Study of Efficacy, Safety, and Pharmacokinetics of PEGylated Recombinant Factor VIII (ADYNOVATE) Administered for Prophylaxis and Treatment of Bleeding in Chinese Previously Treated Patients With Severe Hemophilia A (FVIII <1%) |
Actual Study Start Date : | March 27, 2023 |
Estimated Primary Completion Date : | October 8, 2024 |
Estimated Study Completion Date : | October 8, 2024 |
Arm | Intervention/treatment |
---|---|
Experimental: Adynovate 45±5 IU/kg Participants will receive prophylactic treatment with Adynovate (45 [±5] international units per kilogram [IU/kg]), infusion, intravenously, twice-weekly, over a period of 26 weeks or at least 50 EDs, whichever occurs last. |
Biological: Adynovate |
Ages Eligible for Study: | 12 Years to 65 Years |
Sexes Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |
Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.
Not yet recruiting
Beijing Children's Hospital, Capital Medical University
Beijing, China,
Not yet recruiting
Peking Union Medical College Hospital, Chinese Academy of Medical Sciences
Beijing, China,
Not yet recruiting
Xiangya Hospital of Central South University
Changsha, China,
Not yet recruiting
Fujian Medical University Union Hospital
F U axis, China,
Not yet recruiting
Nanfang Hospital Southern Medical University
Guangzhou, China,
Not yet recruiting
Anhui Province Hospital
Hefei, China,
Not yet recruiting
Jinan Central Hospital
women, China,
Not yet recruiting
Shenzhen Second People's Hospital
Shenzhen, China,
Not yet recruiting
The First Affiliated Hospital of Soochow University
Suzhou, China,
Not yet recruiting
Institute of Hematology and Blood Diseases Hospital Chinese Academy of Medical Sciences
Tianjin, China,
Not yet recruiting
Tongji Hospital Tongji Medical College Huazhong University of Science and Technology
Wuhan, China,
Not yet recruiting
Union Hospital Tongji Medical College Huazhong University of Science and Technology
Wuhan, China,