Last updated 3 months ago
Nuwiq Dosing and Outcomes In the ManagEment of Women/Girls With Haemophilia A Needing FVIII Treatment for Surgery
28 patients around the world
Available in Spain, United States, Uruguay
Female patients with mild to moderate haemophilia A will often need FVIII concentrates to provide haemostatic cover during major surgery. This prospective, open-label, non-controlled, single-arm, multinational, multicentre study aims to evaluate the overall perioperative haemostatic efficacy of Nuwiq in women/girls over 12 with haemophilia A undergoing major surgery requiring FVIII treatment
Octapharma
1Research sites
28Patients around the world
This study is for people with
Hemophilia
Hemophilia a
Requirements for the patient
From 12 Years
Female
Medical requirements
- Women/girls with haemophilia A (FVIII:C ≥1-<40%) according to medical history.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.Women/girls with documented prior treatment with FVIII concentrates or a clinical indication that FVIII treatment would have been appropriate.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.
- Coagulation disorder other than haemophilia A.Present or past FVIII inhibitor (≥0.6 Bethesda units [BU]/mL).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.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.
Sites
Centro Hospitalario Pereira Rossell
SponsorOctapharma
Study typeInterventional
Conditions
Hemophilia a
Requirements
From 12 YearsFemale
Unique study IDclinicaltrials.gov
NCT05936580
