Actively Recruiting
Nuwiq for Perioperative Management Of Patients With Haemophilia A on Emicizumab Regular Prophylaxis Study
Led by Octapharma · Updated on 2026-05-12
28
Participants Needed
18
Research Sites
144 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Recombinant factor VIII for the prevention of bleeding in patients with severe haemophilia A undergoing major surgery while receiving emicizumab prophylaxis
CONDITIONS
Official Title
Nuwiq for Perioperative Management Of Patients With Haemophilia A on Emicizumab Regular Prophylaxis Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male patients aged 12 years or older
- Severe haemophilia A with factor VIII activity less than 1% as per medical history
- Previous treatment with any factor VIII products for at least 150 exposure days
- On regular emicizumab prophylaxis for at least 1 month before scheduled major elective surgery needing factor VIII treatment
- Provided freely given written informed consent according to local regulations
You will not qualify if you...
- Any coagulation disorder other than haemophilia A
- Present or past factor VIII inhibitor of 0.6 Bethesda units/mL or higher
- Severe liver or kidney disease (ALT and/or AST levels more than 5 times upper normal limit, or creatinine over 120 bcmol/L)
- Known allergy to Nuwiq or its ingredients (sucrose, sodium chloride, calcium chloride dihydrate, arginine hydrochloride, sodium citrate dihydrate, poloxamer 188)
- Already undergone surgery in this study
- Current participation in another interventional clinical trial
- Treatment with any investigational medicinal product within 30 days before screening visit
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 18 locations
1
UT Southwestern Medical Center
Dallas, Texas, United States, 75390
Actively Recruiting
2
University Hospital Centre Zagreb
Zagreb, Croatia
Actively Recruiting
3
Helsinki University Hospital
Helsinki, Finland
Actively Recruiting
4
CHU de Nantes Hôtel-Dieu
Nantes, France
Actively Recruiting
5
CHRU de Tours
Tours, France
Actively Recruiting
6
Vivantes Klinikum im Friedrichshein (KFH)
Berlin, Germany
Actively Recruiting
7
Gerinnungszentrum Rhein-Ruhr
Duisburg, Germany
Actively Recruiting
8
Universitätsklinikum Hamburg Eppendorf (UKE)
Hamburg, Germany
Actively Recruiting
9
Christian Medical College Vellore
Vellore, Tamil Nadu, India
Actively Recruiting
10
St. John's Medical College Hospital
Bengaluru, India
Actively Recruiting
11
Azienda Ospedaliera Pugliese Ciaccio
Catanzaro, Italy
Actively Recruiting
12
Azienda Ospedaliero Universitaria Careggi - Centro Emofilia
Florence, Italy
Actively Recruiting
13
Centro Trombosi e Malattie Emorragiche, ITCCS Humanitas Research Hospital
Milan, Italy
Actively Recruiting
14
Centre for Haemopilia, Institute for transfusion medicine of Republic of North Macedonia
Skopje, North Macedonia
Actively Recruiting
15
Clinical Center for Serbia Belgrade
Belgrade, Serbia
Actively Recruiting
16
Hospital Universitario La Paz
Madrid, Spain
Actively Recruiting
17
Hospital Universitario Virgen del Rocio
Seville, Spain
Actively Recruiting
18
St. James's University Hospital
Leeds, United Kingdom
Not Yet Recruiting
Research Team
S
Sigurd Knaub, PhD
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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