(21824) A phase 3, single group treatment, open-label study to evaluate the safety of BAY 94-9027 infusions for prophylaxis and treatment of bleeding in previously treated children aged 7 to <12 years with severe hemophilia A

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2023-504388-18-00

Acronym

BAY 94-9027/21824

Enrollment

Registered

2024-03-12

Start date

2022-09-26

Completion date

2025-03-10

Last updated

2024-10-25

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

Conditions

Severe hemophilia A (<1% FVIII:C)

Brief summary

AESI (hypersensitivity and LOE) associated with the first 4 EDs leading to discontinuation

Detailed description

Adverse drug reactions (ADRs), Anti-drug antibody (ADA) development, Inhibitor development, Annualized bleeding rate (ABR), BAY94-9027 consumption, Number of infusions/month and year (Annualized Infusion Rate)

Interventions

DRUGJivi 500 IU powder and solvent for solution for injection

DRUGJivi 1000 IU powder and solvent for solution for injection

Eligibility

Sex/Gender

Male

Age

0 Years to 17 Years

Design outcomes

Primary

Measure	Time frame
AESI (hypersensitivity and LOE) associated with the first 4 EDs leading to discontinuation	—

Secondary

Measure	Time frame
Adverse drug reactions (ADRs), Anti-drug antibody (ADA) development, Inhibitor development, Annualized bleeding rate (ABR), BAY94-9027 consumption, Number of infusions/month and year (Annualized Infusion Rate)	—

Countries

Italy, Norway

Outcome results

None listed

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