Open-label safety study in adults and adolescents with haemophilia A with and without FVIII inhibitors switching directly from emicizumab prophylaxis to NNC0365-3769 (Mim8) prophylaxis.

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2022-502450-13-00

Acronym

NN7769-4728

Enrollment

Registered

2023-06-20

Start date

2023-07-21

Completion date

2024-06-17

Last updated

2025-11-17

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

Conditions

Haemophilia A with or without coagulation factor VIII (FVIII) inhibitors.

Brief summary

Number of treatment-emergent adverse events (TEAEs).

Detailed description

Device handling experience using haemophilia device assessment tool (H-DAT) questionnaire., Change in participants’ treatment burden using the haemophilia treatment experience measure (Hemo-TEM) total score.

Interventions

DRUGdenecimig

Eligibility

Sex/Gender

All

Age

0 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Number of treatment-emergent adverse events (TEAEs).	—

Secondary

Measure	Time frame
Device handling experience using haemophilia device assessment tool (H-DAT) questionnaire., Change in participants’ treatment burden using the haemophilia treatment experience measure (Hemo-TEM) total score.	—

Countries

Austria, Belgium, France, Germany, Italy, Spain

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026