NN7088-4557: Adverse Event Data Collection from the EUHASS Registry on Turoctocog alfa pegol

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/50382
• EU PAS number:
  EUPAS33777
• Study ID:
  50382
• Official title and acronym:
  NN7088-4557: Adverse Event Data Collection from the EUHASS Registry on Turoctocog alfa pegol
• DARWIN EU® study:
  No
• Study countries:
  Afghanistan

  Albania
• Study description:
  This non-interventional study concerns a safety data collection based on adverse event data from a third-party registry (European Haemophilia Safety Surveillance System, EUHASS) that includes information about adverse events from patients with haemophilia A treated with turoctocog alfapegol. There is no extra burden to the patients by participating in this registry-based data collection.
• Study status:
  Ongoing

Research institution and networks

Institutions

Novo Nordisk

Study timelines

Date when funding contract was signed

Actual: 17/12/2019

Study start date

Planned: 09/12/2020

Actual: 09/12/2020

Date of final study report

Planned: 10/09/2025

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Novo Nordisk A/S

Study protocol

Initial protocol

_ Protocol 4557 protocol eu-pas-reg redacted

Regulatory

• Was the study required by a regulatory body?:
  Yes
• Is the study required by a Risk Management Plan (RMP)?:
  EU RMP category 3 (required)

Other study registration identification numbers and links

U1111-1235-5939