Actively Recruiting
Nuwiq Dosing and Outcomes In the ManagEment of Women/Girls With Haemophilia A Needing FVIII Treatment for Surgery
Led by Octapharma · Updated on 2026-05-12
28
Participants Needed
16
Research Sites
43 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Recombinant factor VIII for the prevention of bleeding in women/girls with haemophilia A undergoing major surgery
CONDITIONS
Official Title
Nuwiq Dosing and Outcomes In the ManagEment of Women/Girls With Haemophilia A Needing FVIII Treatment for Surgery
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Women or girls with haemophilia A with factor VIII activity between 1% and less than 40%, or 40%-50% with documented significant bleeding history or prior FVIII treatment
- At least 12 years of age
- Scheduled for major surgery requiring factor VIII treatment, including elective, emergency, or planned caesarean sections
- Provided freely given written informed consent according to local regulations
You will not qualify if you...
- Any coagulation disorder other than haemophilia A
- Presence or history of factor VIII inhibitors (≥0.6 Bethesda units/mL)
- Severe liver or kidney disease (ALT or AST levels greater than 5 times normal, or creatinine over 120 µmol/L)
- Known allergy to Nuwiq or its ingredients
- Pregnancy unless undergoing planned caesarean section
- Previous surgery in this study
- Current participation in another interventional trial
- Use of investigational medicinal products within 30 days before screening
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 16 locations
1
UT Health San Antonio
San Antonio, Texas, United States, 78229
Actively Recruiting
2
Helsinki University Hospital,Coagulation Disorder Unit
Helsinki, Finland
Actively Recruiting
3
Avenue de la République
Chambray-lès-Tours, France
Actively Recruiting
4
CHU de Nantes Hôtel-Dieu
Nantes, France
Actively Recruiting
5
Chu de Strasbourg
Stasbourg, France
Not Yet Recruiting
6
Universitätsklinikum Bonn,Institut für Experimentelle Haematologie und Transfusionsmedizin
Bonn, Germany
Actively Recruiting
7
Gerinnungszentrum Rhein-Ruhr
Duisburg, Germany
Actively Recruiting
8
Universitätsklinikum Hamburg Eppendorf,II. Medizinische Klinik und Poliklinik
Hamburg, Germany
Actively Recruiting
9
Aziendo Ospedaliera "Puglieze Ciaccio"
Catanzaro, Italy
Actively Recruiting
10
Policlinico "P. Giaconne"
Palermo, Italy
Actively Recruiting
11
Clinical Center for Serbia
Belgrade, Serbia
Actively Recruiting
12
Hospital Universitario la Paz
Madrid, Spain
Actively Recruiting
13
Hospital Universitario Virgen del Rocio
Seville, Spain
Actively Recruiting
14
Insel Spital Bern
Bern, Switzerland
Not Yet Recruiting
15
St. James's University Hospital
Leeds, United Kingdom
Actively Recruiting
16
Centro Hospitalario Pereira Rossell
Montevideo, Uruguay
Not Yet Recruiting
Research Team
C
Cristina Solomon
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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