Using Nuwiq to manage bleeding in women and girls with Hemophilia A during 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)
This study is testing if Nuwiq can help prevent bleeding during major surgeries for women and girls aged 12 and older with mild to moderate Hemophilia A.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 28 (estimated) |
| Ages | 12 Years and up |
| Sex | Female |
| Sponsor | Octapharma Industry-sponsored |
| Locations | 16 sites (San Antonio, Texas and 15 other locations) |
| Trial ID | NCT05936580 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of Nuwiq, a recombinant factor VIII, in preventing bleeding during major surgeries in women and girls aged 12 and older with mild to moderate Hemophilia A. It is a prospective, open-label, non-controlled, single-arm, multinational, multicenter study. Participants will receive Nuwiq to ensure adequate hemostatic cover during their surgical procedures. The study aims to assess the overall perioperative efficacy of this treatment in managing bleeding risks associated with surgery.
Who should consider this trial
Good fit: Ideal candidates are women and girls aged 12 and older with mild to moderate Hemophilia A scheduled for major elective surgery requiring FVIII treatment.
Not a fit: Patients with other coagulation disorders, severe liver or kidney disease, or those who are pregnant may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve surgical outcomes and safety for women and girls with Hemophilia A by providing effective bleeding management.
How similar studies have performed: Other studies have shown success with similar approaches in managing bleeding in Hemophilia A patients, indicating a promising avenue for treatment.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
San Antonio, Texas and 15 other locations
- UT Health San Antonio — San Antonio, Texas, United States (Recruiting)
- Helsinki University Hospital,Coagulation Disorder Unit — Helsinki, Finland (Recruiting)
- Avenue de la République — Chambray-lès-Tours, France (Recruiting)
- CHU de Nantes Hôtel-Dieu — Nantes, France (Recruiting)
- Chu de Strasbourg — Stasbourg, France (Not_yet_recruiting)
- Universitätsklinikum Bonn,Institut für Experimentelle Haematologie und Transfusionsmedizin — Bonn, Germany (Recruiting)
- Gerinnungszentrum Rhein-Ruhr — Duisburg, Germany (Recruiting)
- Universitätsklinikum Hamburg Eppendorf,II. Medizinische Klinik und Poliklinik — Hamburg, Germany (Recruiting)
- Aziendo Ospedaliera "Puglieze Ciaccio" — Catanzaro, Italy (Recruiting)
- Policlinico "P. Giaconne" — Palermo, Italy (Recruiting)
- Clinical Center for Serbia — Belgrade, Serbia (Recruiting)
- Hospital Universitario la Paz — Madrid, Spain (Recruiting)
- Hospital Universitario Virgen del Rocio — Seville, Spain (Recruiting)
- Insel Spital Bern — Bern, Switzerland (Not_yet_recruiting)
- St. James's University Hospital — Leeds, United Kingdom (Recruiting)
- Centro Hospitalario Pereira Rossell — Montevideo, Uruguay (Not_yet_recruiting)
Study contacts
- Principal investigator: Johannes Oldenburg — Experimental Haematology and Transfusion Medicine, University Clinic Bonn
- Study coordinator: Cristina Solomon
- Email: cristina.solomon@octapharma.com
- Phone: +41795859042
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.