Multicenter observation study to examine the usefulness of transgenic blood coagulation factor VIII Fc fusion protein (rFVIIIFc) preparation for domestic pediatric hemophilia A patients

Multicenter observation study to examine the usefulness of transgenic blood coagulation factor VIII Fc fusion protein (rFVIIIFc) preparation for domestic pediatric hemophilia A patients - Fc Adolescent and Children Treatment study (FACTs)

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000028834

Enrollment

Registered

2017-09-01

Start date

2017-09-01

Completion date

Unknown

Last updated

2026-06-29

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

Conditions

hemophilia A

Interventions

Blood coagulation preparation rFVIIIFc over 2 years 25-65 IU/kg/dose The dosing interval ranges from 3 to 5 days

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Hemophilia A patients who are planning to administer rFVIIIFc or have started administration within the past 12 months

Exclusion criteria

Exclusion criteria: Patients who are unable or unwilling to provide informed consent

Design outcomes

Primary

Measure	Time frame
Number of annual spontaneous bleeding episodes over 2 years from registration	—

Countries

Japan

Contacts

Public ContactYasutomo Funakoshi

Nagasaki University Hospital Department of pediatrics

funakoshi@nagasaki-u.ac.jp095-819-7298

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026