Pharmacokinetics
Conditions
Keywords
Hemophilia A，pharmacokinetics
Brief summary
The study start on June 30, 2018. The Severe(F Ⅷ\<1%) hemophilia A children without F Ⅷ inhibitor combining were recruited to Test the concentration of the drug in the blood to provide better treatment.
Detailed description
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.
Interventions
DRUGconcentrated FVIII
Intervention if the assessment considers that the treatment is inadequate
Sponsors
Beijing Children's Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
1 Years to 14 Years
Healthy volunteers
No
Inclusion criteria
* FⅧ\<1% , * 1-14years old, * There have been at least one history of bleeding in any joint of the knee, elbow, or ankle. * A blood product containing FVIII is applied. * There were no inhibitors at the time of enrollment, and there was no inhibitor-positive history and family history. * Clinical visits are available on a regular basis and data is available, and preventive treatment is available prior to enrollment. * The child was enrolled in the group and the guardian agreed.
Exclusion criteria
* Combining other disease researchers believes that it is not suitable for enrollment. * FVIII inhibitor was found. * Refuse to participate in research
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Ultrasound evaluation | 3 years | the sonographer will use ultrasound to assess whether the patient's joint lesions become more severe than when they were enrolled. |
| Imaging evaluation | 3 years | the imaging specialist will use MRI to assess whether the patient's joint lesions are more severe than when they were enrolled. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Annualized Bleeding Rate | 3 years | How many times for all types of bleeding |
| Annualized Joint Bleeding Rate | 3 years | How many times for joint bleeding |
Countries
China
Contacts
Primary Contactchen zhen ping, Ph.D
Outcome results
None listed