Pharmacokinetic (PK)Research on Chinese Children of Hemophilia

NCT ID: NCT03622476

Last Updated: 2018-08-14

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 155 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-06-30
• Study Completion Date: 2021-08-30

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.

Conditions

Pharmacokinetics

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

concentrated FVIII

Intervention Type: DRUG

Intervention if the assessment considers that the treatment is inadequate

Interventions

concentrated FVIII

Intervention if the assessment considers that the treatment is inadequate

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 1 Year
• Maximum Eligible Age: 14 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Beijing Children's Hospital

OTHER

Sponsor Role: lead

Responsible Party

Runhui WU

Capital Medical Univercity

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Beijing Children's Hospital

Beijing, Beijing Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

chen zhen ping, Ph.D

Role: CONTACT

chenzhenping@outlook.com

15011221677

Facility Contacts

chen zhenping, Ph.D

Role: primary

Other Identifiers

BCH-PK-20180630

Identifier Type: -

Identifier Source: org_study_id