Pharmacokinetics of human coagulation factor IX in children with hemophilia B in China

Status

Active, not recruiting

Phases

Phase 4

Study type

Observational

Source

ChiCTR

Registry ID

ChiCTR2200059494

Enrollment

Unknown

Registered

2022-05-02

Start date

2022-05-30

Completion date

Unknown

Last updated

2024-03-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

hemophilia B

Interventions

None listed

Eligibility

Sex/Gender

Male

Age

1 Years to 12 Years

Inclusion criteria

Inclusion criteria: 1. Children aged 1-12 years (weight >= 10 kg) with moderate to severe hemophilia B in China (coagulation factor IX activity 50 ED); 5. Evidence of an informed consent document signed and dated by the legal guardian, indicating that the subject has been informed of all relevant content of the study; 6. Subjects who are willing and able to comply with planned visits, treatment plans, laboratory tests and other test procedures.

Exclusion criteria

Exclusion criteria: 1. Existence of FIX inhibitors or history of inhibitors; 2. Subjects known to have hypersensitivity to the active ingredient of human coagulation factor IX or any excipients; 3. Unwillingness or inability to comply with program requirements.

Design outcomes

Primary

Measure	Time frame
pharmacokinetics;	—

Contacts

Public ContactGuoqing Liu

Beijing Children’s Hospital, Capital Medical University

982947192@qq.com+86 18810324215

Outcome results