NuDIMENSION

• Research type

  Research Study

• Full title

  Nuwiq Dosing and outcomes In the ManagEment of women/girls with haemophilia A Needing FVIII treatment for Surgery – an International, Open-label, Non-controlled study (NuDIMENSION)

• IRAS ID

  1008855

• Contact name

  Sigurd Knaub

• Contact email

  sigurd.knaub@octapharma.com

• Sponsor organisation

  Octapharma AG

• Eudract number

  2022-502061-17

• Clinicaltrials.gov Identifier

  NCT05936580

• Research summary

  This is a phase 4, prospective, open-label, uncontrolled, single-arm, multinational, multicentre study that will be conducted at
  approximately 15 sites worldwide. All patients are scheduled to undergo a major surgical procedure and will perioperative be receiving Nuwiq. A maximum of 28 patients will be enrolled in order to document 26 evaluable major surgeries (each subject can have only one surgery in the study). Each patient (women/girls only) will be in the study from the time of the screening visit until 30 days after the day of the surgical procedure or at the day of discharge (whichever comes last). The primary objective of this study is to evaluate the overall perioperative haemostatic efficacy of Nuwiq in women/girls with haemophilia A undergoing major surgery.

• REC name

  South Central - Hampshire A Research Ethics Committee

• REC reference

  24/SC/0017

• Date of REC Opinion

  2 Feb 2024

• REC opinion

  Further Information Favourable Opinion