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Primary objective: To assess the pharmacokinetics, Safety and immunogenicity of Repeat Dosing of PEG Recombinant Human Coagulation Factor VIII-Fc Fusion Protein for Injection With Severe Hemophilia A(FRSW117) Secondary objectives: To assess Preliminary efficacy of Repeat Dosing of PEG Recombinant Human Coagulation Factor VIII-Fc Fusion Protein for Injection With Severe Hemophilia A.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1 prophylaxis treatment | Experimental | Subjects of high dose group are being received four doses of FRSW117. dosing on day1(ED1), day8(ED2), day15(ED3), day22(ED4) respectively. Subjects of low dose group are being received four doses of FRSW117. dosing on day1(ED1), day8(ED2), day15(ED3), day22(ED4) respectively. All subjects are being received PK assessment in ED1 and ED4. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| FRSW117 | Drug | Subjects of high dose group are being received four doses(50 IU/kg,once a week or every 7 days) of FRSW117. Subjects of low dose group (40 IU/kg,once a week or every 7 days)are being received four doses of FRSW117. |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum measured concentration of FVIII:C (Cmax) | Measured by One-Stage Clotting Assay | Pre-dose and post dose up to 10 days |
| Time required for the concentration of the drug to reach half of its original value (T1/2) | Measured by One-Stage Clotting Assay | Pre-dose and post dose up to 10 days |
| Area Under the Curve to Infinity (AUC) | Measured by One-Stage Clotting Assay | Pre-dose and post dose up to 10 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 One-Stage Clotting Assay | Pre-dose and post dose up to 10 days |
| Evaluation of the level of anti-PEG-rFâ…§Fc antibody production in participants | Pre-dose and post dose up to 36 days | |
| Evaluation of the level of anti-PEG antibody production in participants | Pre-dose and post dose up to 36 days |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with treatment-related adverse events as assessed by CTCAE V5.0 | Adverse events related to PEG Recombinant Human Coagulation Factor VIII-Fc Fusion Protein according to Common Terminology Criteria for Adverse Events (CTCAE) NCI.V5.0. | Pre-dose and post dose up to 36 days |
| Development of Inhibitor |
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Key Inclusion Criteria:
Key Exclusion Criteria:
Other protocol-defined inclusion/exclusion Criteria May Apply.
Hemophilia A is an X-chromosome-linked recessive inherited bleeding disorder caused by a deficiency of coagulation factor VIII (FVIII)
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| Name | Affiliation | Role |
|---|---|---|
| Renchi Yang, PhD | Institute of Hematology & Blood Diseases Hospital Chinese Academy of Medical Sciences & Peking Union Medical College. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| People'S Hospital of Zhengzhou | Zhengzhou | Henan | 450000 | China | ||
| Affiliated Hospital of Jiangnan University |
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| ID | Term |
|---|---|
| D006467 | Hemophilia A |
| ID | Term |
|---|---|
| D025861 | Blood Coagulation Disorders, Inherited |
| D001778 | Blood Coagulation Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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| ID | Term |
|---|---|
| D007267 | Injections |
| ID | Term |
|---|---|
| D004333 | Drug Administration Routes |
| D004358 | Drug Therapy |
| D013812 | Therapeutics |
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|
Measured by the Nijmegen-Modified Bethesda Assay |
| Pre-dose and post dose up to 36 days |
| score of bleeding symptoms and Vital signs | Response to treatment with PEG Recombinant Human Coagulation Factor VIII-Fc Fusion Protein for bleeding episodes, using the 4-point bleeding response scale | Pre-dose and post dose up to 36 days |
| Wuxi |
| Jiangsu |
| 214100 |
| China |
| The Affiliated Hospital of Qingdao University | Qingdao | Shandong | 266000 | China |
| People'S Hospital of Rizhao | Rizhao | Shandong | 276800 | China |
| Institute of Hematology & Blood Diseases Hospital Chinese Academy of Medical Sciences & Peking Union Medical College. | Tianjin | Tianjin Municipality | 300020 | China |
| D020147 | Coagulation Protein Disorders |
| D006474 | Hemorrhagic Disorders |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |