RECRUITINGPhase 4INTERVENTIONAL
Nuwiq Dosing and Outcomes In the ManagEment of Women/Girls With Haemophilia A Needing FVIII Treatment for Surgery
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)
About This Trial
Recombinant factor VIII for the prevention of bleeding in women/girls with haemophilia A undergoing major surgery
Who May Be Eligible (Plain English)
Who May Qualify:
1. 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)
2. At least 12 years of age
3. Scheduled to undergo major surgery\* requiring FVIII treatment, including elective and emergency procedures and caesarean section in pregnant women with haemophilia A
4. Freely given written willing to sign a consent form of the patient, or parent/legal representative where applicable, obtained in accordance with local regulations
Who Should NOT Join This Trial:
1. Coagulation disorder other than haemophilia A
2. Present or past FVIII inhibitor (≥0.6 Bethesda units \[BU\]/mL)
3. 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)
4. Known hypersensitivity to Nuwiq's active substance or its excipients (sucrose, sodium chloride, calcium chloride dihydrate, arginine hydrochloride, sodium citrate dihydrate, poloxamer 188)
5. Pregnancy, except in participants with a planned caesarean section
6. Already had surgery in this study
7. Current participation in another interventional clinical trial
8. Treatment with any investigational medicinal product (IMP) within 30 days prior to screening visit
Always talk to your doctor about whether this trial is right for you.
Original Eligibility Criteria
View original clinical language
Inclusion Criteria:
1. 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)
2. At least 12 years of age
3. Scheduled to undergo major surgery\* requiring FVIII treatment, including elective and emergency procedures and caesarean section in pregnant women with haemophilia A
4. Freely given written informed consent of the patient, or parent/legal representative where applicable, obtained in accordance with local regulations
Exclusion Criteria:
1. Coagulation disorder other than haemophilia A
2. Present or past FVIII inhibitor (≥0.6 Bethesda units \[BU\]/mL)
3. 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)
4. Known hypersensitivity to Nuwiq's active substance or its excipients (sucrose, sodium chloride, calcium chloride dihydrate, arginine hydrochloride, sodium citrate dihydrate, poloxamer 188)
5. Pregnancy, except in participants with a planned caesarean section
6. Already had surgery in this study
7. Current participation in another interventional clinical trial
8. Treatment with any investigational medicinal product (IMP) within 30 days prior to screening visit
Treatments Being Tested
DRUG
Nuwiq
Nuwiq is a purified B-domain-deleted FVIII glycoprotein synthesised by a genetically engineered human embryonic kidney cell line (HEK 293F).
Locations (15)
UT Health San Antonio
San Antonio, Texas, United States
Helsinki University Hospital,Coagulation Disorder Unit
Helsinki, Finland
Avenue de la République
Chambray-lès-Tours, France
CHU de Nantes Hôtel-Dieu
Nantes, France
Universitätsklinikum Bonn,Institut für Experimentelle Haematologie und Transfusionsmedizin
Bonn, Germany
Gerinnungszentrum Rhein-Ruhr
Duisburg, Germany
Universitätsklinikum Hamburg Eppendorf,II. Medizinische Klinik und Poliklinik
Hamburg, Germany
Aziendo Ospedaliera "Puglieze Ciaccio"
Catanzaro, Italy
Policlinico "P. Giaconne"
Palermo, Italy
Clinical Center for Serbia
Belgrade, Serbia
Hospital Universitario la Paz
Madrid, Spain
Hospital Universitario Virgen del Rocio
Seville, Spain
Insel Spital Bern
Bern, Switzerland
St. James's University Hospital
Leeds, United Kingdom
Centro Hospitalario Pereira Rossell
Montevideo, Uruguay