Non-interventional, descriptive, retrospective study using data from the FranceCoag system in hemophilia A patients with anti-factor VIII inhibitors treated with Hemlibra®.

Progress

Inclusions closed on 10/29/2021
Analyses finalized on 07/25/2022
Article in submission

Presentation and objectives

The aim of this study is to describe the characteristics of the patients, their therapeutic management, their clinical course (occurrence of bleeding events and bleeding requiring treatment), and the events that occurred from the initiation of Hemlibra® prophylaxis.

Persons concerned
Type of data collected
(*data excluding FranceCoag)

Severe hemophilia A with inhibitor

Regulatory approvals
Information note

Favourable opinion from FranceCoag’s Scientific Committee
MR004 declared to the CNIL

NI Children
NI Adolescents
NI ParentsFavorable opinion of the FranceCoag Scientific Committee
MR004 declared to the CNIL

NI Adults and Parents

Project sponsor (financier)

Roche Laboratory