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Taking peoplePhase 4

Nuwiq dosing to prevent bleeding in girls and women with haemophilia A during surgery

Tests Nuwiq, a clotting factor, to prevent bleeding during surgery in females with haemophilia A.

Plain-language title generated from the registry record
Registry title: Nuwiq Dosing and Outcomes In the ManagEment of Women/Girls With Haemophilia A Needing FVIII Treatment for Surgery

Key facts

Where
Montevideo, UruguaySee the site
Phase
Phase 4

AI summary: who the study is looking for

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for women and girls with haemophilia A who are due to have major surgery that needs factor VIII (FVIII) treatment.

Age
12 years or older
Sex
Women and girls only
Disease stage
Haemophilia A with FVIII activity of at least 1% and under 40%. Women and girls with 40% to 50% can join if they have a documented history of clinically significant bleeding that fits haemophilia A, and/or prior FVIII treatment or a clinical reason for it. Surgery must be major, planned or emergency, including caesarean section.
Earlier treatment
No FVIII inhibitor, now or in the past. No other investigational medicine within 30 days before screening.
Biomarker or test result
FVIII activity level (FVIII:C) of at least 1% and under 40% (40% to 50% only in the cases described above).

Main reasons for not taking part

  • Another blood clotting disorder besides haemophilia A
  • Present or past FVIII inhibitor (0.6 Bethesda units/mL or more)
  • Severe liver or kidney disease
  • Known allergy to Nuwiq's active substance or its other ingredients
  • Pregnancy, unless a caesarean section is planned

Read by machine on 12 November 2026.

Where in Uruguay

  • Centro Hospitalario Pereira RossellMontevideo, UruguayContact: Cristina SolomonNot yet recruiting

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Trial details

Who runs it
Octapharma
Trial code
NCT05936580
Record updated
12 May 2026
Original description
Recombinant factor VIII for the prevention of bleeding in women/girls with haemophilia A undergoing major surgeryRead full original descriptionShow less

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)

Recombinant factor VIII for the prevention of bleeding in women/girls with haemophilia A undergoing major surgery

Inclusion: Women/girls with haemophilia A (FVIII:C ≥1-<40%) according to medical history. Additionally, women/girls with documented FVIII activity levels between ≥ 40% and 50% may be included if there is a documented history of clinically significant bleeding episodes consistent with haemophilia A; and/or either documented prior treatment with FVIII concentrates or a clinical indication that FVIII treatment would have been appropriate (e.g., use of FVIII from a family member, or treatment with alternative haemostatic agents due to access limitations); At least 12 years of age; Scheduled to undergo major surgery* requiring FVIII treatment, including elective and emergency procedures and caesarean section in pregnant women with haemophilia A; Freely given written informed consent of the patient, or parent/legal representative where applicable, obtained in accordance with local regulations.

Exclusion: Present or past FVIII inhibitor (≥0.6 Bethesda units [BU]/mL); Already had surgery in this study; Treatment with any investigational medicinal product (IMP) within 30 days prior to screening visit; Coagulation disorder other than haemophilia A; Severe liver or kidney disease (alanine aminotransferase [ALT] and/or aspartate aminotransferase [AST] levels >5 times the upper limit of normal; or creatinine >120 μmol/L); Known hypersensitivity to Nuwiq's active substance or its excipients (sucrose, sodium chloride, calcium chloride dihydrate, arginine hydrochloride, sodium citrate dihydrate, poloxamer 188); Pregnancy, except in participants with a planned caesarean section; Current participation in another interventional clinical trial.

ClinicalTrials.gov NCT05936580