A Patient Registry of patients with high-risk neuroblastoma being treated with the monoclonal antibody dinutuximab beta

Study summary

No information provided.

Study identification

• EU PAS number:
  EUPAS31973
• Study ID:
  45710
• Official title and acronym:
  A Patient Registry of patients with high-risk neuroblastoma being treated with the monoclonal antibody dinutuximab beta
• DARWIN EU® study:
  No
• Study countries:
  Austria

  France

  Germany

  Hungary

  Italy

  Poland

  Spain

  United Kingdom
• Study description:
  EUSA DB 0001 is a long-term non-interventional, multi-national, observational and prospective registry designed to capture data from real-world clinical practice to further evaluate efficacy and safety of the monoclonal antibody dinutuximab beta. This registry will provide information on pain severity and use of analgesics during treatment, incidence of neurotoxicity, visual impairment, capillary leak syndrome, cardiovascular events, hypersensitivity reactions, long-term safety and survival.
• Study status:
  Ongoing

Research institutions and networks

Institutions

Recordati

Austria
St. Anna Kinderspital
France
Institut Gustave Roussy
Centre Oscar Lambret
Hôpital de la Timone
Germany
Universitätsmedizin Greifswald
Universitätsmedizin Berlin
Italy
IRCCS Istituto Giannina Gaslini
Poland
Uniwersytecki Szpital Dzieciecy w Krakowie
Spain
Hospital Universitario I Politècnico de La Fe
Hospital Universitari Vall d'Hebron
United Kingdom
Southampton University Hospital NHS Foundation Trust
University Hospitals Birmingham NHS Foundation Trust
Tweddle Newcastle Hospitals NHS Foundation Trust
Hungary
Debreceni Egyetem Klinikai Kozpont

Networks

Paediatric Oncology for the Treatment of Neuroblastoma (SIOPEN)

Study timelines

Date when funding contract was signed

Planned:28/09/2015

Actual:28/09/2015

Study start date

Planned:19/09/2019

Actual:30/09/2019

Data analysis start date

Planned:01/07/2036

Date of interim report, if expected

Planned:17/09/2025

Date of final study report

Planned:15/12/2036

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Recordati UK Ltd.

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)

Other study registration identification numbers and links

Protocol number EUSA DB 0001