Trial intelligence / Profile preview

Phase 3 open-label safety study of Jivi (BAY 94-9027) in children with severe hemophilia A

2023-504388-18-00Phase 3Completed

Sponsor
Bayer
Start
Sep 2022
Modality
Recombinant Proteins and Enzymes, Biodegradable Polymers → Polymer-based Nanoparticles → Nanoparticles → Drug Delivery Systems
Countries
7
01

Overview

Phase 3, open-label, single-arm trial of damoctocog alfa pegol in hemophilia A, sponsored by Bayer. Primary endpoint: AESI (hypersensitivity and loss of efficacy) associated with the first 4 exposure days leading to discontinuation. Started Sep 2022; status: completed.

02

Drugs

damoctocog alfa pegol
03

Conditions

hemophilia A

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