NN7999-4413: Adverse Event Data Collection from External Registries on Nonacog Beta Pegol

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/27138
• EU PAS number:
  EUPAS25696
• Study ID:
  27138
• Official title and acronym:
  NN7999-4413: Adverse Event Data Collection from External Registries on Nonacog Beta Pegol
• DARWIN EU® study:
  No
• Study countries:
  Netherlands

  United Kingdom
• Study description:
  The purpose of this study is to collect data on adverse events from third party registries that include information about adverse events from patients with haemophilia B treated with nonacog beta pegol. The third party registries include PedNet Haemophilia Registry (PedNet) and the European Haemophilia Safety Surveillance System (EUHASS). Data from national and international registries in countries where nonacog beta pegol has been approved and marketed could be included in the data collection.
• Study status:
  Ongoing

Research institutions and networks

Institutions

Novo Nordisk

Study timelines

Date when funding contract was signed

Planned: 31/08/2017

Actual: 14/09/2018

Study start date

Planned: 01/10/2018

Actual: 01/10/2018

Date of final study report

Planned: 01/10/2028

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Novo Nordisk A/S

Study protocol

Initial protocol

4413-protocol-eu-pas-reg-redacted

Regulatory

• Was the study required by a regulatory body?:
  No
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable

Other study registration identification numbers and links

UTN:U1111-1212-4050NCT:NCT03690336