Study identification

PURI

https://redirect.ema.europa.eu/resource/49016

EU PAS number

EUPAS23177

Study ID

49016

Official title and acronym

Surveillance Of Emicizumab-Treated Patients: An Analysis of the EUHASS Pharmacovigilance Registry (Emicizumab Pharmacovigilance: EUHASS registry)

DARWIN EU® study

No

Study countries

Austria
Belgium
Bulgaria
Croatia
Cyprus
Czechia
Denmark
Finland
France
Germany
Greece
Hungary
Ireland
Italy
Latvia
Lithuania
Malta
Netherlands
Norway
Poland
Portugal
Romania
Russian Federation
Slovakia
Slovenia
Spain
Sweden
Switzerland
Türkiye
United Kingdom

Study description

This is a cohort-surveillance, secondary data use, non-interventional, post authorization safety study (PASS) based on data collected by the European Haemophilia Safety Surveillance System (EUHASS) from participating centers. The main goal of this study is to assess the incidence of thromboembolism (TE), thrombotic microangiopathy (TMA), and anaphylaxis under real-world conditions in patients exposed to emicizumab with or without coagulation factor products. Secondary objectives are: to estimate the incidence of TE and TMA in patients exposed to emicizumab alone and concomitantly with each of the following drugs: activated prothrombin complex concentrate (aPCC), recombinant activated factor VII (rFVIIa), and factor VIII (FVIII) product, to describe individual cases of TE and TMA identified in EUHASS, to summarize the frequency of other adverse events collected by EUHASS in patients exposed to emicizumab, and to describe individual cases of “unexpected poor efficacy” reported to EUHASS based on the available information.

Study status

Ongoing
Research institutions and networks

Institutions

Networks

EUHASS

Contact details

Letizia Polito

Primary lead investigator
Study timelines

Date when funding contract was signed

Actual:

Study start date

Planned:
Actual:

Data analysis start date

Planned:

Date of final study report

Planned:
Sources of funding
Pharmaceutical company and other private sector 

More details on funding

F. Hoffmann-La Roche, Ltd.
Study protocol
Initial protocol

Prot GO40162 Hemlibra v1_Redacted

English (983.2 KB - PDF)View document
Updated protocol

GO40162- Protocol v4_Redacted.pdf

English (1.36 MB - PDF)View document
Regulatory

Was the study required by a regulatory body?

No

Is the study required by a Risk Management Plan (RMP)?

EU RMP category 3 (required)