Using Nuwiq to manage bleeding in hemophilia A patients during major surgery
Nuwiq for Perioperative Management Of Patients With Haemophilia A on Emicizumab Regular Prophylaxis Study (NuPOWER)
This study is testing if Nuwiq can help prevent bleeding during major surgery for boys and men over 12 with severe hemophilia A who are already using another treatment called emicizumab.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 28 (estimated) |
| Ages | 12 Years and up |
| Sex | Male |
| Sponsor | Octapharma Industry-sponsored |
| Drugs / interventions | emicizumab |
| Locations | 18 sites (Dallas, Texas and 17 other locations) |
| Trial ID | NCT05935358 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of Nuwiq, a recombinant factor VIII, in preventing bleeding during major surgery in male patients over 12 years old with severe hemophilia A who are already receiving emicizumab prophylaxis. It is a prospective, open-label, uncontrolled, single-arm, multinational, multicenter study. The aim is to assess the overall perioperative hemostatic efficacy of Nuwiq in this specific patient population. Participants must have a history of severe hemophilia A and have been on emicizumab for at least one month prior to surgery.
Who should consider this trial
Good fit: Ideal candidates are male patients aged 12 and older with severe hemophilia A who have been on emicizumab prophylaxis and require major surgery.
Not a fit: Patients with other coagulation disorders, FVIII inhibitors, severe liver or kidney disease, or known hypersensitivity to Nuwiq will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve bleeding management during surgeries for patients with severe hemophilia A.
How similar studies have performed: Other studies have shown promising results with similar approaches in managing bleeding in hemophilia patients, indicating potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Severe haemophilia A (FVIII activity \[FVIII:C\] \<1%) according to medical history * 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: * Coagulation disorder other than haemophilia A * 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
Where this trial is running
Dallas, Texas and 17 other locations
- UT Southwestern Medical Center — Dallas, Texas, United States (Recruiting)
- University Hospital Centre Zagreb — Zagreb, Croatia (Recruiting)
- Helsinki University Hospital — Helsinki, Finland (Recruiting)
- CHU de Nantes Hôtel-Dieu — Nantes, France (Recruiting)
- CHRU de Tours — Tours, France (Recruiting)
- Vivantes Klinikum im Friedrichshein (KFH) — Berlin, Germany (Recruiting)
- Gerinnungszentrum Rhein-Ruhr — Duisburg, Germany (Recruiting)
- Universitätsklinikum Hamburg Eppendorf (UKE) — Hamburg, Germany (Recruiting)
- Christian Medical College Vellore — Vellore, Tamil Nadu, India (Recruiting)
- St. John's Medical College Hospital — Bengaluru, India (Recruiting)
- Azienda Ospedaliera Pugliese Ciaccio — Catanzaro, Italy (Recruiting)
- Azienda Ospedaliero Universitaria Careggi - Centro Emofilia — Florence, Italy (Recruiting)
- Centro Trombosi e Malattie Emorragiche, ITCCS Humanitas Research Hospital — Milan, Italy (Recruiting)
- Centre for Haemopilia, Institute for transfusion medicine of Republic of North Macedonia — Skopje, North Macedonia (Recruiting)
- Clinical Center for Serbia Belgrade — Belgrade, Serbia (Recruiting)
- Hospital Universitario La Paz — Madrid, Spain (Recruiting)
- Hospital Universitario Virgen del Rocio — Seville, Spain (Recruiting)
- St. James's University Hospital — Leeds, United Kingdom (Not_yet_recruiting)
Study contacts
- Principal investigator: Shveta Gupta, MD — Arnold Palmer Hospital for Children
- Study coordinator: Sigurd Knaub, PhD
- Email: Sigurd.Knaub@octapharma.com
- Phone: +41 554512141
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.