Pharmacokinetic (PK)Research on Chinese Children of Hemophilia (PK)
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|ClinicalTrials.gov Identifier: NCT03622476|
Recruitment Status : Recruiting
First Posted : August 9, 2018
Last Update Posted : August 14, 2018
|Condition or disease||Intervention/treatment||Phase|
|Pharmacokinetics||Drug: concentrated FVIII||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||155 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Capital Characteristic Application: Pharmacokinetic（PK） Research on Chinese Children of Hemophilia|
|Actual Study Start Date :||June 30, 2018|
|Estimated Primary Completion Date :||July 30, 2021|
|Estimated Study Completion Date :||August 30, 2021|
Experimental: PK research
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.
Drug: concentrated FVIII
Intervention if the assessment considers that the treatment is inadequate
- Ultrasound evaluation [ Time Frame: 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 [ Time Frame: 3 years ]the imaging specialist will use MRI to assess whether the patient's joint lesions are more severe than when they were enrolled.
- Annualized Bleeding Rate [ Time Frame: 3 years ]How many times for all types of bleeding
- Annualized Joint Bleeding Rate [ Time Frame: 3 years ]How many times for joint bleeding
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03622476
|Contact: chen zhen ping, Ph.Demail@example.com|
|Beijing Children's Hospital||Recruiting|
|Beijing, Beijing, China, 100045|
|Contact: chen zhenping, Ph.D|