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This is a multi-center, open-label, single-arm trial to evaluate the efficacy and safety of Recombinant Coagulation Factor VIII in patients with hemophilia A . Recombinant Coagulation Factor VIII is prophylactic administrated 25 - 35 IU/kg once every other day or three times per week which should be continuous for 24 weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Prophylactic therapy | Experimental | Subjects received Recombinant Human Coagulation FVIII for prophylactic therapy with 25 - 35 IU/kg injection once every other day or three times per week for 6 months. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Recombinant Human Coagulation FVIII | Drug | A kind of Recombinant Coagulation Factor VIII Injection produced by sponsor. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Annualized joint bleeding rate | Annualized joint bleeding rate(AJBR) can be calculated using the following formula: Number of joint bleeding events during efficacy evaluation period/(number of days in treatment period/365.25). | up to 24 weeks |
| Incremental Recovery of the First Dose | Peak activity of FVIII (as Cmax) measured within 1 hour after the end of injection | After the first dose on day 1 |
| Measure | Description | Time Frame |
|---|---|---|
| Bleeding Event Treatment Efficacy | The investigator shall evaluate the hemostatic effect after the treatment of every bleeding event of subjects based on a four-point scale(excellent, good, moderate, not relieved). | up to 24 weeks |
| Monthly Average Number of Bleedings |
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Inclusion Criteria:
4)Has received FVIII treatment and the treatment exposure days ≥100. 5)Has bleeding treatment records of at least 3 months before randomization. 6)FVIII inhibitor assay results is negative. 7) Subjects should agree to use an adequate method of contraception during the study.
8)Understood and Signed an informed consent form.
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Lei Zhang, Doctor | Contact | 022-20909240 | zhanglei1@ihcams.ac.cn |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| AnHui Provincial Hospital | Recruiting | Hefei | Anhui | 230001 | China |
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Number of bleeding events in each month. |
| up to 24 weeks |
| The number and dose of injection of Recombinant Human Coagulation FVIII required per bleeding episode | The number and dose of injection of Recombinant Human Coagulation FVIII required per bleeding episode | up to 24 weeks |
| Incremental Recovery of Duplicated Dose | Peak activity of FVIII (as Cmax) measured within 1 hour after the end of injection. | up to 12 weeks, 24 weeks |
| Hemophilia Joint Health Score (HJHS) | The scale assesses the functional status of the six major joints of the elbow, knee, and ankle, including: joint swelling, swelling duration, muscle atrophy, muscle strength, joint friction, joint pain, joint extension, joint flexion Degree decline, overall gait, etc. | Baseline, week 24 |
| Assess the impact of Recombinant Human Coagulation FVIII following Patient Reported Outcome (PRO) EQ-5D | EQ-5D is a general questionnaire designed to measure health status on a scale of 0-100 with the higher value representing a better outcome and record the participants' current health state in 5 domains mobility, selfcare, usual activities, pain, anxiety. | Baseline, week 24 |
| The Second Affiliated Hospital of Chongqing Medical University | Recruiting | Chongqing | Chongqing Municipality | 400010 | China |
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| FuJian Medical University Union Hospital | Recruiting | Fuzhou | Fujian | 350001 | China |
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| The First Hospital of LanZhou University | Recruiting | Lanzhou | Gansu | 730000 | China |
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| The First Affiliated Hospital of Guangxi Medical University | Recruiting | Nanning | Guangxi | 530021 | China |
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| HeNan Provincial Peoples Hospital | Recruiting | Zhengzhou | Henan | 450003 | China |
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| HeNan Cancer Provincial Hospital | Recruiting | Zhengzhou | Henan | 450008 | China |
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| Xiangya Hospital Central South University | Recruiting | Changsha | Hunan | 410013 | China |
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| Nanjing Drum Tower Hospital | Recruiting | Nanjing | Jiangsu | 210008 | China |
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| Jiangxi Provincial People's Hospital | Recruiting | Nanchang | Jiangxi | 330006 | China |
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| Hematology and Blood Diseases Hospital, Chinese Academy of Medical Sciences | Recruiting | Tianjin | Tianjin Municipality | 300020 | China |
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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 |
| D020147 | Coagulation Protein Disorders |
| D006474 | Hemorrhagic Disorders |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
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