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A multicenter prospective observational study on the prevention or suppression of progress of hemophilic arthropathy in hemophilia patients with inhibitors undergoing prophylaxis of Byclot.

A multicenter prospective observational study on the prevention or suppression of progress of hemophilic arthropathy in hemophilia patients with inhibitors undergoing prophylaxis of Byclot.

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
JPRN
Registry ID
JPRN-jRCT1031240268
Enrollment
10
Registered
2024-08-09
Start date
2024-07-11
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/B inhibitor

Interventions

None listed

Sponsors

hagiwara tsuyoshi
Lead Sponsor
KM Biologics Co.,Ltd.
Collaborator

Eligibility

Sex/Gender
Male

Inclusion criteria

Inclusion criteria: 1) hemophilia Patients with inhibitors who are undergoing prophylaxis with Byclot(regardless of age) 2) Patients who have given written consent to this study from themselves or their legal guardian

Exclusion criteria

Exclusion criteria: 1) Patients whose joints cannot be evaluated 2) Patients with a history of joint surgery within the past 6 months from the date of informed consent 3) Patients judged to be inappropriate to participate in this study by the principal investigator

Design outcomes

Primary

MeasureTime frame
1) Joint function evaluation by Haemophilia Jpoint Health Score (HJHS) (Changes in HJHS scores over time from the start to 3 years later)

Secondary

MeasureTime frame
1) Changes in joint image evaluation (X-ray:Pettersson score, ultrasound: HEAD-US score) over time . 2) Changes in annual bleeding rate (ABR) and annual joint bleeding rate (AjBR) over time. 3) Clinical test values: APTT, PT, FVIII activity and FVIII inhibitor titer for hemophilia A inhibitor patients, FIX activity and FIX inhibitor titer changes over time for hemophilia B inhibitor patients.

Contacts

Public Contacttsuyoshi hagiwara

Ogikubo hospital

thagi@tokyo-med.ac.jp+81-3-3399-1101

Outcome results

None listed

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