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| Name | Class |
|---|---|
| Hangzhou Gensciences Biopharmaceutical Co., Ltd. | INDUSTRY |
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The primary objectives of the study are to further evaluate the efficacy and safety of Recombinant Human Coagulation Factor VIII-Fc Fusion Protein for Injection (FRSW107) in adolescent and adult patients with hemophilia A.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1 | Experimental | Participants will receive prophylaxis treatment with Recombinant Human Coagulation Factor VIII-Fc fusion for 6 months. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Recombinant Human Coagulation Factor VIII-Fc Fusion Protein for Injection | Drug | Participants received prophylaxis treatment at 50 IU/ kg every three days.30-50 IU/kg is recommended to administration while bleeding occurs during the experiment. |
| Measure | Description | Time Frame |
|---|---|---|
| Annualized Bleeding Rates (ABR). | Annualized bleeding rate = (number of bleeding episodes during the efficacy, period/total number of days during the efficacy period)*365.25. The efficacy period begins with the first prophylactic dose of FRSW107 and ends with the last dose (for prophylaxis or a bleed). Surgery/rehabilitation periods are not included in the efficacy period. A bleeding episode started from the first sign of a bleed and ended no more than 72 hours after the last treatment for the bleed, within which any symptoms of bleeding at the same location or injections less than or equal to 72 hours apart were considered the same bleeding episode. Any injection to treat the bleeding episode taken more than 72 hours after the preceding one was considered the first injection to treat a new bleeding episode at the same location. Any bleeding at a different location was considered a separate bleeding episode, regardless of time from last injection. | For the duration of study participation, 6 months. |
| Number of target joints. | Describe the number and percentage of cases with target joints ≥1 and their 95% confidence intervals before and after drug administration, and compare the change in the number of target joints from baseline after treatment. | For the duration of study participation, 6 months. |
| Annualized Joint Bleeding Rate (AJBR) | Annualized joint bleeding rate(AJBR)can be calculated using the following formula: Number of joint bleeding episodesevents during efficacy evaluation period/(number of days in treatment period/365.25). | For the duration of study participation, 6 months. |
| Measure | Description | Time Frame |
|---|---|---|
| Total Dose Required for Resolution of a Bleeding Episode. | The total dose required to resolve a bleeding episode per participant, based on the efficacy period. The efficacy period begins with the first dose and ends with the last dose (for a bleed). For 'Per bleeding episode' values, for each bleeding episode, the total dose is the sum of the doses (IU/kg) administered across all injections given to treat that bleeding episode. For 'Per participant' values, the total dose (IU/kg) used to resolve each bleed is averaged across all bleeding episodes per participant. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Renchi Yang | Institute of Hematology & Blood Diseases Hospital Chinese Academy of Medical Sciences & Peking Union Medical College. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Anhui Provincial Hospital | Hefei | Anhui | 230001 | China | ||
| Capital Medical University affiliated Beijing Children's Hospital |
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| For the duration of study participation, 6 months. |
| Number of injections required to resolve a bleeding episode. | The number of injections required to resolve a bleeding episode per participant, based on the efficacy period. The efficacy period begins with the first dose and ends with the last dose (for a bleed). All injections given from the initial sign of a bleed, until the last date/time within the bleed window are counted. The resolution of a bleed is defined as no sign of bleeding following injection for the bleed. For 'Per participant' values, the number of injections required to resolve each bleed is averaged across all bleeding episodes per participant. | For the duration of study participation, 6 months. |
| Quality of life assessment. | Quality of life assessment by Haemophilia Joint Health Score(HJHS 2.1). | For the duration of study participation, 6 months. |
| Score of bleeding symptoms and Vital signs. | Response to treatment with rFVIIIFc for bleeding episodes, using the 4-point bleeding response scale. | For the duration of study participation, 6 months. |
| Number of participants with inhibitor development | Number of participants who developed a positive FVIII inhibitor level (≥0.6 Bethesda unit [BU]) during the study was summarized and classified as participants developing low titer inhibitor (i.e. ≤ 5.0 BU) and participants developing high titer inhibitor (i.e. > 5.0 BU). | For the duration of study participation, 6 months. |
| Number of Participants With Incidence of Antibody Formation to CHINESE HAMSTER OVARY (CHO). | A test to analyze the formation of antibodies to CHO. | For the duration of study participation, 6 months. |
| Number of Participants With Adverse Events (AEs) and Serious Adverse Events. (SAEs) as a Measure of Safety and Tolerability. | An AE is any untoward medical occurrence that does not necessarily have a causal relationship with this treatment. An SAE is any untoward medical occurrence that at any dose: results in death; in the view of the Investigator, places the participant at immediate risk of death (a life-threatening event); requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; results in a congenital anomaly/birth defect; any other medically important event that, in the opinion of the Investigator, may jeopardize the participant or may require intervention to prevent one of the other outcomes listed in the definition. | For the duration of study participation, 6 months. |
| Beijing |
| Beijing Municipality |
| 100045 |
| China |
| Chongqing Three Gorges Central Hospital | Chongqing | Chongqing Municipality | 404000 | China |
| The First Hospital of Lanzhou University | Lanzhou | Gansu | 730000 | China |
| The Second Affiliated Hospital of Guangzhou Medical University | Guangzhou | Guangzhou | 510260 | China |
| Nanfang Hospital of Southern Medical University | Guangzhou | Guangzhou | 510515 | China |
| The Affiliated Hospital of Guizhou Medical University | Guiyang | Guizhou | 550004 | China |
| Henan provincial People's Hospital | Zhengzhou | He'nan | 450003 | China |
| Henan Cancer Hospital | Zhengzhou | He'nan | 450008 | China |
| Xiangya Hospital of Central South University | Changsha | Hunan | 410013 | China |
| The Affiliated Hospital of Xuzhou Medical College | Xuzhou | Jiangsu | 221002 | China |
| Jiangxi Provincial People's Hospital | Nanchang | Jiangxi | 330006 | China |
| Jinan central hospital | Ji'nan | Shandong | 250013 | China |
| The Affiliated Hospital of Qingdao University | Qingdao | Shandong | 266000 | China |
| The Second Hospital of Shanxi Medical University | Taiyuan | Shanxi | 030001 | China |
| Institute of Hematology & Blood Diseases Hospital Chinese Academy of Medical Sciences & Peking Union Medical College. | Tianjin | Tianjin Municipality | 300020 | 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 |
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| ID | Term |
|---|---|
| D007267 | Injections |
| ID | Term |
|---|---|
| D004333 | Drug Administration Routes |
| D004358 | Drug Therapy |
| D013812 | Therapeutics |
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