Nuwiq for Perioperative Management Of Patients With Haemophilia A on Emicizumab Regular Prophylaxis Study
NCT ID: NCT05935358
Last Updated: 2025-10-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE4
28 participants
INTERVENTIONAL
2023-11-28
2026-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Nuwiq
All patients receiving Nuwiq (recombinant FVIII). Nuwiq will be administered intravenously in accordance with the relevant prescribing information. Treatment will be repeated as necessary every 8-24 hours until adequate wound healing, then - if required - for at least another 7 days to maintain FVIII plasma levels of 30-60 IU/dL.
Nuwiq
Nuwiq is a purified B-domain-deleted FVIII glycoprotein synthesised by a genetically engineered human embryonic kidney cell line (HEK 293F).
Interventions
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Nuwiq
Nuwiq is a purified B-domain-deleted FVIII glycoprotein synthesised by a genetically engineered human embryonic kidney cell line (HEK 293F).
Eligibility Criteria
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Inclusion Criteria
* Male patients at least 12 years of age
* Previous treatment with any FVIII product(s) for at least 150 exposure days
* On regular prophylaxis with emicizumab for at least 1 month prior to a scheduled major elective surgery requiring FVIII treatment
* Freely given written informed consent of the patient, or parent/legal representative where applicable, obtained in accordance with local regulations
Exclusion Criteria
* Present or past FVIII inhibitor (≥0.6 Bethesda units \[BU\]/mL) according to medical history
* 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)
* Already had surgery in this study
* Current participation in another interventional clinical trial
* Treatment with any investigational medicinal product (IMP) within 30 days prior to screening visit
12 Years
MALE
No
Sponsors
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Octapharma
INDUSTRY
Responsible Party
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Principal Investigators
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Shveta Gupta, MD
Role: PRINCIPAL_INVESTIGATOR
Arnold Palmer Hospital for Children
Locations
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UT Southwestern Medical Center
Dallas, Texas, United States
University Hospital Centre Zagreb
Zagreb, , Croatia
Helsinki University Hospital
Helsinki, , Finland
CHU de Nantes Hôtel-Dieu
Nantes, , France
CHRU de Tours
Tours, , France
Vivantes Klinikum im Friedrichshein (KFH)
Berlin, , Germany
Gerinnungszentrum Rhein-Ruhr
Duisburg, , Germany
Universitätsklinikum Hamburg Eppendorf (UKE)
Hamburg, , Germany
Christian Medical College Vellore
Vellore, Tamil Nadu, India
St. John's Medical College Hospital
Bengaluru, , India
Azienda Ospedaliera Pugliese Ciaccio
Catanzaro, , Italy
Azienda Ospedaliero Universitaria Careggi - Centro Emofilia
Florence, , Italy
Centro Trombosi e Malattie Emorragiche, ITCCS Humanitas Research Hospital
Milan, , Italy
Centre for Haemopilia, Institute for transfusion medicine of Republic of North Macedonia
Skopje, , North Macedonia
Clinical Center for Serbia Belgrade
Belgrade, , Serbia
Hospital Universitario La Paz
Madrid, , Spain
Hospital Universitario Virgen del Rocio
Seville, , Spain
St. James's University Hospital
Leeds, , United Kingdom
Countries
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Central Contacts
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References
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Srivastava A, Kanny A, Langer F, Kubicek-Hofmann C, Alvarez Roman MT, Nunez Vazquez R, Boban A, Dejanova-Ilijevska V, Miljic P, Garcia J, Halimeh S, Drillaud N, Valentin JB, Mancuso ME, Castaman G, Santoro RC, Lehtinen AE, Abraham A, Hashimoto M, Knaub S. NuPOWER (Nuwiq for Perioperative management Of patients With haemophilia A on Emicizumab Regular prophylaxis): protocol for an open-label, single-arm, multicentre study. BMJ Open. 2025 Oct 28;15(10):e102657. doi: 10.1136/bmjopen-2025-102657.
Other Identifiers
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GENA-22
Identifier Type: -
Identifier Source: org_study_id
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