Nuwiq Dosing and Outcomes In the ManagEment of Women/Girls With Haemophilia A Needing FVIII Treatment for Surgery

Last updated: April 16, 2025
Sponsor: Octapharma
Overall Status: Active - Recruiting

Phase

4

Condition

Hemophilia

Treatment

Nuwiq

Clinical Study ID

NCT05936580
GENA-23
  • Ages > 12
  • Female

Study Summary

Recombinant factor VIII for the prevention of bleeding in women/girls with haemophilia A undergoing major surgery

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Women/girls with haemophilia A (FVIII:C ≥1-<40%) according to medical history

  2. At least 12 years of age

  3. Scheduled to undergo major elective surgery requiring FVIII treatment

  4. Freely given written informed consent of the patient, or parent/legal representativewhere applicable, obtained in accordance with local regulations

Exclusion

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 aspartateaminotransferase [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 citratedihydrate, poloxamer 188)

  5. Pregnancy

  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 toscreening visit

Study Design

Total Participants: 28
Treatment Group(s): 1
Primary Treatment: Nuwiq
Phase: 4
Study Start date:
September 01, 2025
Estimated Completion Date:
February 28, 2027

Study Description

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

Connect with a study center

  • Helsinki University Hospital,Coagulation Disorder Unit

    Helsinki,
    Finland

    Active - Recruiting

  • Avenue de la République

    Chambray-lès-Tours,
    France

    Active - Recruiting

  • CHU de Nantes Hôtel-Dieu

    Nantes,
    France

    Active - Recruiting

  • Universitätsklinikum Bonn,Institut für Experimentelle Haematologie und Transfusionsmedizin

    Bonn,
    Germany

    Active - Recruiting

  • Gerinnungszentrum Rhein-Ruhr

    Duisburg,
    Germany

    Active - Recruiting

  • Universitätsklinikum Hamburg Eppendorf,II. Medizinische Klinik und Poliklinik

    Hamburg,
    Germany

    Active - Recruiting

  • Aziendo Ospedaliera "Puglieze Ciaccio"

    Catanzaro,
    Italy

    Active - Recruiting

  • Policlinico "P. Giaconne"

    Palermo,
    Italy

    Active - Recruiting

  • Clinical Center for Serbia

    Belgrade,
    Serbia

    Active - Recruiting

  • Hospital Universitario la Paz

    Madrid,
    Spain

    Active - Recruiting

  • Hospital Universitario Virgen del Rocio

    Sevilla,
    Spain

    Active - Recruiting

  • St. James's University Hospital

    Leeds,
    United Kingdom

    Site Not Available

  • UT Health San Antonio

    San Antonio, Texas 78229
    United States

    Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.