Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Primary objective: To assess the pharmacokinetics of Recombinant Human Coagulation Factor VIII, Fc Fusion Protein for Injection (FRSW107) Secondary objectives: To assess Safety and Tolerability by monitoring FVIII recovery and adverse events in Severe Hemophilia A.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1 | Experimental | Subjects(up to 12 years of age) received two treatments: 50 IU/kg ADVATE in the first period, followed by 50 IU/kg FRSW107 in the second period. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ADVATE | Drug | 50 international units (IU)/kg, a single dose. |
| |
| FRSW107 |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum measured concentration of FVIII:C (Cmax) | Measured by aPTT Clotting Assay. | Pre-dose and post dose up to 8 days. |
| Time required for the concentration of the drug to reach half of its original value (T1/2) | Measured by aPTT Clotting Assay. | Pre-dose and post dose up to 8 days |
| Area Under the Curve to Infinity (AUC) | Measured by aPTT Clotting Assay. | Pre-dose and post dose up to 8 days. |
| The measure of the efficiency of the body to remove the drug and the unit is the volume of the plasma or blood cleared of drug per unit time (CL). | Measured by aPTT Clotting Assay. | Pre-dose and post dose up to 8 days. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with treatment-related adverse events as assessed by CTCAE V5.0. | Adverse events related to Recombinant Human Coagulation Factor VIII-Fc fusion protein for Injection according to Common Terminology Criteria for Adverse Events (CTCAE) NCI.V5.0. | Post dose up to 32 days. |
| Development of Inhibitor |
Not provided
Key Inclusion Criteria:
Key Exclusion Criteria:
Hemophilia A is an X-chromosome-linked recessive inherited bleeding disorder caused by a deficiency of coagulation factor VIII (FVIII).
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Runhui Wu, PhD | Beijing Children's Hospital | Principal Investigator |
| Xiaoling Wang, MA.Sc | Beijing Children's Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Children's Hospital,Capital Medical University | Beijing | Beijing Municipality | 100045 | China | ||
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Drug |
50 IU/kg, a single dose. |
|
|
Measured by the Nijmegen-Modified Bethesda Assay. |
| Pre-dose and post dose up to 32 days. |
| Shenzhen Children's Hospita |
| Shenzhen |
| Guangdong |
| 518000 |
| China |
| Nanfang Hospital of Southern Medical University | Guangzhou | Guangzhou | 510515 | China |
| Tongji Hospital, Tongji Medical College, Huazhong University of Science & Technology | Wuhan | Hubei | 430000 | China |
| The Affiliated Hospital of Qingdao University | Qingdao | Shandong | 266000 | China |
| Chengdu Women's and Children's Central Hospital | Chengdu | Sichuan | 610000 | China |
| ID | Term |
|---|---|
| D006467 | Hemophilia A |
| ID | Term |
|---|---|
| D025861 | Blood Coagulation Disorders, Inherited |
| D001778 | Blood Coagulation Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D020147 | Coagulation Protein Disorders |
| D006474 | Hemorrhagic Disorders |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
Not provided
Not provided
| ID | Term |
|---|---|
| D005169 | Factor VIII |
| D007267 | Injections |
| ID | Term |
|---|---|
| D001779 | Blood Coagulation Factors |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D011498 | Protein Precursors |
| D001685 | Biological Factors |
| D004333 | Drug Administration Routes |
| D004358 | Drug Therapy |
| D013812 | Therapeutics |
Not provided
Not provided