Using Nuwiq to manage bleeding in hemophilia A patients during major 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 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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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

Similar studies

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

• Switching from Emicizumab to Marstacimab in Severe Hemophilia A

  This study is testing if switching from emicizumab to marstacimab is safe and how well the body handles the new medication in people with severe hemophilia A.

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• Understanding antibody changes in hemophilia A patients treated with emicizumab

  This study looks at how the immune system reacts to emicizumab treatment in people with severe hemophilia A by checking leftover samples from their regular doctor visits.

  Recruiting Goethe University · Frankfurt am Main, Hesse · NCT05802836

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

  This will test whether NXT007 prevents bleeding better than emicizumab in people aged 12 and older with Hemophilia A, including those with or without factor VIII inhibitors.

  Recruiting at 63 sites Phase 3 Hoffmann-La Roche · Orange, California and 62 other locations · NCT07416604

• Emicizumab prophylaxis for people with Type 3 von Willebrand disease

  This trial will test whether regular emicizumab injections reduce bleeds compared with on-demand standard therapy for people aged 1 month and older with Type 3 von Willebrand disease, while also studying people already on prophylaxis using their prior data.

  Recruiting at 29 sites Phase 3 Hoffmann-La Roche · Sacramento, California and 28 other locations · NCT06998524

• Testing fitusiran to prevent bleeds in severe hemophilia A patients switching from emicizumab

  This study is testing if fitusiran can help prevent bleeding in men with severe hemophilia A who are switching from another treatment called emicizumab.

  Recruiting at 3 sites Phase 4 Sanofi · Los Angeles, California and 2 other locations · NCT06145373

• Emicizumab treatment for severe Von Willebrand Disease and Hemophilia A

  This study is testing if a new injection called Emicizumab can help people with severe Von Willebrand Disease or both Von Willebrand Disease and Hemophilia A prevent serious bleeding better than current treatments.

  Recruiting at 12 sites Phase 1 Bleeding and Clotting Disorders Institute Peoria, Illinois · Orange, California and 11 other locations · NCT05500807

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.