Using Nuwiq to manage bleeding in women and girls with Hemophilia A during surgery

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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
• Universitätsklinikum Bonn,Institut für Experimentelle Haematologie und Transfusionsmedizin
  Bonn, Germany Recruiting
• Gerinnungszentrum Rhein-Ruhr
  Duisburg, Germany 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• NXT007 versus emicizumab to prevent bleeds in people with Hemophilia A

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.