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The study start on June 30, 2018. The Severe(F â…§<1%) hemophilia A children without F â…§ inhibitor combining were recruited to Test the concentration of the drug in the blood to provide better treatment.
Through the integration of two technologies, pharmacokinetics and comprehensive evaluation system, we can improve the individualized prevention and treatment of hemophilia in Chinese children and achieve precise customization of treatment plans. Rational use of medical resources, but also fully achieve the prevention and treatment goals.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PK research | Experimental | Interventional studies were performed in the 1-7 year old subgroup, and the children received a comprehensive assessment and PK test every 3 months. After the 72-hour washout period, 50 IU/kg of concentrated FVIII was administered in a single dose, and blood was taken within half an hour before the infusion and 1 h, 9 h, 24 h, and 48 h after the infusion, and the samples were centrifuged. If the assessment considers that the treatment is inadequate, then the valley concentration target is upgraded. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| concentrated FVIII | Drug | Intervention if the assessment considers that the treatment is inadequate |
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| Measure | Description | Time Frame |
|---|---|---|
| Ultrasound evaluation | the sonographer will use ultrasound to assess whether the patient's joint lesions become more severe than when they were enrolled. | 3 years |
| Imaging evaluation | the imaging specialist will use MRI to assess whether the patient's joint lesions are more severe than when they were enrolled. | 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| Annualized Bleeding Rate | How many times for all types of bleeding | 3 years |
| Annualized Joint Bleeding Rate | How many times for joint bleeding |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| chen zhen ping, Ph.D | Contact | 15011221677 | chenzhenping@outlook.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Children's Hospital | Recruiting | Beijing | Beijing Municipality | 100045 | China |
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| 3 years |