Pharmacokinetic (PK)Research on Chinese Children of Hemophilia

Pharmacokinetics Clinical Trial

— PK  

Official title:

Capital Characteristic Application: Pharmacokinetic（PK） Research on Chinese Children of Hemophilia

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03622476
• Other study ID #: BCH-PK-20180630
• Status: Recruiting
• Phase: Phase 4
• Start date: June 30, 2018
• Est. completion date: August 30, 2021

Study information

• Verified date: August 2018
• Source: Beijing Children's Hospital
• Contact: chen zhen ping, Ph.D
• Phone: 15011221677
• Email: chenzhenping[@]outlook.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 155
• Est. completion date: August 30, 2021
• Est. primary completion date: July 30, 2021
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 1 Year to 14 Years

Eligibility

Inclusion Criteria:

• F?<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

Related Conditions & MeSH terms

• Hemophilia A
• Pharmacokinetics

Intervention

Drug:
• concentrated FVIII
Intervention if the assessment considers that the treatment is inadequate

Locations

Country	Name	City	State
China	Beijing Children's Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Beijing Children's Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Secondary	Annualized Bleeding Rate	How many times for all types of bleeding	3 years
Secondary	Annualized Joint Bleeding Rate	How many times for joint bleeding	3 years