NN7999-4031: A Non-Interventional Post-Authorisation Safety Study (PASS) in male haemophilia B patients receiving Nonacog Beta Pegol (N9-GP) prophylaxis treatment

Study identification

• EU PAS number:
  EUPAS26592
• Study ID:
  42488
• Official title and acronym:
  NN7999-4031: A Non-Interventional Post-Authorisation Safety Study (PASS) in male haemophilia B patients receiving Nonacog Beta Pegol (N9-GP) prophylaxis treatment
• DARWIN EU® study:
  No
• Study countries:
  Austria

  Belgium

  Canada

  Denmark

  Germany

  Greece

  Netherlands

  Norway

  Portugal

  Spain

  Sweden

  Switzerland

  United Kingdom
• Study description:
  This study will collect information on side effects and how well Refixia/REBINYN works during long-term treatment (prophylaxis) in males with haemophilia B. While taking part in this study, participants will receive the same treatment as given to them by their study doctor. All visits at the clinic are done in the same way as the participants are used to. During visits at the clinic, participants might be asked for some relevant tests if considered useful by their study doctor. During the visits, the participants study doctor might ask if the participants had any side effects since their last study visit. The participants will be asked to note down the number of bleeds and the treatment of their bleeds as well as their regular prophylaxis. During the visits to the clinic, the participants will be asked to answer some questionnaires about their quality of life and their ability to be physically active. The participant’s participation in the study will last for 4-9 years, depending on when they 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 institutions and networks

Institutions

Novo Nordisk

Study timelines

Date when funding contract was signed

Actual: 08/07/2015

Study start date

Planned: 01/04/2019

Actual: 01/04/2019

Date of final study report

Planned: 15/12/2028

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Novo Nordisk A/S

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

ClinicalTrials.gov identifier: NCT03745924WHO UTN number: U1111-1165-8657