Study identification

EU PAS number

EUPAS31973

Study ID

45710

Official title and acronym

A Post-Authorisation Safety Study Patient Registry of patients with high-risk neuroblastoma being treated with the monoclonal antibody dinutuximab beta (EUSA DB 0001)

DARWIN EU® study

No

Study countries

Austria
France
Germany
Italy
Poland
Spain
United Kingdom

Study description

EUSA DB 0001 is a non-interventional, multi-national, observational, prospective registry designed to capture data from real-world clinical practice to further evaluate efficacy and safety of dinutuximab beta

Study status

Ongoing
Research institutions and networks

Institutions

EUSA Pharma
First published:
01/02/2024
Institution
Gustave Roussy
France
First published:
01/02/2024
Institution Educational Institution Hospital/Clinic/Other health care facility
St. Anna Kinderspital Austria, Hospital Universitario y Politécnico la Fe Valencia, Spain, Institut Gustave Roussy Villejulf, France, Institut Curie Paris, France, Centre Oscar Lambret Lille, France, Hopital de la Timone Enfants, Marseille Marseille, France, Universitätsmedizin Greifswald Greifswald, Germany, Charité – Universitätsmedizin Berlin Berlin, Germany, Szpital Uniwersytecki Krakowie Ul. Wielicka 265 Krakow, Poland, IRCCS Istituto Giannina Gaslini Genova, Italy

Networks

Paediatric Oncology for the Treatment of Neuroblastoma (SIOPEN)

Contact details

Jose-Luis Garcia

Primary lead investigator

Study timelines

Date when funding contract was signed

Planned:
Actual:

Study start date

Planned:
Actual:

Data analysis start date

Planned:

Date of interim report, if expected

Planned:

Date of final study report

Planned:
Sources of funding
Pharmaceutical company and other private sector 

More details on funding

EUSA Pharma
Regulatory

Was the study required by a regulatory body?

Yes

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

EU RMP category 2 (specific obligation of marketing authorisation)