NN7088-4029 A multinational, prospective, open labelled, non-controlled, non-interventional post-authorisation study of turoctocog alfa pegol (N8-GP) during long-term routine prophylaxis and treatment of bleeding episodes in patients with haemophilia A (pathfinder 9)

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/39327
• EU PAS number:
  EUPAS36536
• Study ID:
  39327
• Official title and acronym:
  NN7088-4029 A multinational, prospective, open labelled, non-controlled, non-interventional post-authorisation study of turoctocog alfa pegol (N8-GP) during long-term routine prophylaxis and treatment of bleeding episodes in patients with haemophilia A (pathfinder 9)
• DARWIN EU® study:
  No
• Study countries:
  Austria

  Bulgaria

  Croatia

  Germany

  Greece

  Hungary

  Italy

  Lithuania

  Portugal

  Slovakia

  Slovenia

  Spain

  Switzerland
• Study description:
  This study will collect information on side effects and how well Esperoct® (turoctocog alfa pegol (N8-GP)) works during long-term treatment (prophylaxis) in males with haemophilia A. Participants in this study will get the same treatment as they would normally get, if they were not participating in the study. All visits at the clinic are done in the same way as participants are used to, when visiting their doctor. During visits at the clinic participants might be asked for some relevant tests if considered useful by the study doctor. During the visits the study doctor might ask if participants had any side effects since the last study visit. Participants will be asked to note down in their own diary the number of bleeds and how these were treated, as well as their regular prophylaxis. Participation in the study will last for about 5-7 years, depending on when participants join the study. Participants are free to leave the study at any time and for any reason. This will not affect their current and future medical care.
• Study status:
  Ongoing

Research institution and networks

Institutions

Novo Nordisk

Study timelines

Date when funding contract was signed

Actual: 17/04/2020

Study start date

Planned: 01/10/2020

Actual: 23/10/2020

Date of final study report

Planned: 02/06/2028

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Novo Nordisk A/S

Study protocol

Initial protocol

4029-protocol-eu-pas-reg-redacted

Updated protocol

_ Protocol 4029 protocol eu-pas-reg redacted (1)

Regulatory

• Was the study required by a regulatory body?:
  Yes
• Is the study required by a Risk Management Plan (RMP)?:
  EU RMP category 1 (imposed as condition of marketing authorisation)

Other study registration identification numbers and links

UTN: U1111-1235-6007