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This study is a single arm, open, multicenter clinical trial in which the previous treated severe hemophilia A patients receive recombinant human coagulation factor VIII for injection to evaluate the efficacy and safety of on-demand treatment in the event of new bleeding events. If evaluable surgical cases occur, the overall efficacy and safety of recombinant human coagulation factor VIII for injection as a replacement therapy for severe hemophilia A PTPs during the perioperative period will be evaluated.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Recombinant human activated coagulation factor Ⅷ for injection | Experimental | Each subject in this study receive on-demand treatment with recombinant human coagulation factor VIII for injection for 180 days, with an increase in medication frequency based on the relief after medication. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Recombinant human activated coagulation factor VIII for injection | Drug | Recombinant human coagulation factor VIII for injection is a recombinant DNA product with functional characteristics comparable to endogenous factor VIII. |
| Measure | Description | Time Frame |
|---|---|---|
| The proportion of on-demand treatment improvement for newly occurring bleeding events | Evaluate the hemostatic efficacy of the patient after each new bleeding event (including new bleeding events during visits and new bleeding events during home treatment), and calculate the proportion of improvement as excellent+good to the total number of on-demand treatment evaluations. | For each new bleeding event, assessed within 72 hours after initial treatment |
| Activity recovery | The activity of Recombinant human coagulation factor VIII measured at 15 minutes after infusion minus the baseline Recombinant human coagulation factor VIII activity divided by the expected improvement in Recombinant human coagulation factor VIII activity, which reflects the improvement in Recombinant human coagulation factor VIII levels after infusion. | 15 minutes after infusion |
| Measure | Description | Time Frame |
|---|---|---|
| The proportion of effective surgical hemostasis | Assess the hemostatic efficacy of injecting recombinant human coagulation factor VIII during and after surgery. The effective ratio is the proportion of excellent or good to the total times of the surgical evaluation of hemostatic efficacy | Within 72 hours after surgery |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fuyang Hospital Affiliated to Anhui Medical University | Fuyang | Anhui | 236000 | China | ||
| Anhui Provincial Hospital |
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| Annualized bleeding rate (ABR) |
Including spontaneous and traumatic bleeding, as well as total bleeding; ABR can be calculated using the following formula: bleeding frequency/(treatment period days/365.25). |
| Up to 180 days. |
| The incidence of Less Han Expected Thermal Effect | Without the influence of confounding factors, continuously infuse Recombinant human coagulation factor VIII twice within 24 hours for on-demand treatment, with no response to the same bleeding event. | For each new bleeding event, assessed within 24 hours after initial treatment |
| The injection times of recombinant human coagulation factor VIII | The injection times of recombinant human coagulation factor VIII for each new bleeding event. | Up to 180 days. |
| The dosage of recombinant human coagulation factor VIII | The dosage of recombinant human coagulation factor VIII (including average and total doses) for each new bleeding event | Up to 180 days. |
| Changes of Haemophilia Joint Health Score before and after on-demand treatment | 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. | Up to 180 days. |
| Changes of Quality of Life Assessment before and after on-demand treatment | Quality of Life Assessment 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. | Up to 180 days. |
| The incidence of recombinant human coagulation factor VIII inhibitors | The incidence of recombinant human coagulation factor VIII inhibitors | Up to 180 days |
| Incremental recovery in non-bleeding state | Calculated from the peak FVIII activity (expressed as Cmax) measured within 1 hour after the end of infusion. | Within 1 hour after infusion |
| The incidence of adverse events was assessed by vital signs | The incidence of adverse events was assessed by vital signs. | Up to 180 days |
| The incidence of adverse events was assessed by physical examination | The incidence of adverse events was assessed by physical examination. | Up to 180 days |
| The incidence of adverse events was assessed by electrocardiogram | The incidence of adverse events was assessed by electrocardiogram. | Up to 180 days |
| The incidence of adverse events was assessed by laboratory tests | The incidence of adverse events was assessed by laboratory tests. | Up to 180 days |
| Hefei |
| Anhui |
| 230002 |
| China |
| The Second Affiliated Hospital of Chongqing Medical University | Chongqing | Chongqing Municipality | 400010 | China |
| The First Hospital of Lanzhou University | Lanzhou | Gansu | 730013 | China |
| Nanfang Hospital, Southern Medical University | Guangzhou | Guangdong | 510515 | China |
| The First Affiliated Hospital of Guangxi Medical University | Nanning | Guangxi | 530021 | China |
| Henan Tumor Hospital | Zhengzhou | Henan | 450003 | China |
| Xiangya Hospital Central South University | Changsha | Hunan | 410008 | China |
| Nanjing Drug Tower Hospital | Nanjing | Jiangsu | 210008 | China |
| Jiangxi Provincial People's Hospital | Nanchang | Jiangxi | 330006 | China |
| Hematology Hospital of Chinese Academy of Medical Sciences | Tianjin | Tianjin Municipality | 300020 | China |
| The Second Affiliated Hospital of Kunming Medical University | Kunming | Yunnan | 650106 | 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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