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NCT05936580 | RECRUITING | Hemophilia A

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

Octapharma

Brief Summary:

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

Condition or disease

Hemophilia A

Intervention/treatment

Nuwiq

Phase

PHASE4

Detailed 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

Study Type : INTERVENTIONAL
Estimated Enrollment : 28 participants
Masking : NONE
Primary Purpose : TREATMENT
Official Title : 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)
Actual Study Start Date : 2026-04
Estimated Primary Completion Date : 2027-02
Estimated Study Completion Date : 2027-02

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 12 Years
Sexes Eligible for Study: FEMALE
Accepts Healthy Volunteers:
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
Nuwiq Dosing and Outcomes In the ManagEment of Women/Girls With Haemophilia A Needing FVIII Treatment for Surgery

Location Details

NCT05936580

Please Choose a site

How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

RECRUITING

United States, Texas

UT Health San Antonio

Saint Anthony, Texas, United States, 78229

RECRUITING

Finland,

Helsinki University Hospital,Coagulation Disorder Unit

Helsinki, Finland,

RECRUITING

France,

Republic Avenue

Chambray-lès-Tours, France,

RECRUITING

France,

Nantes Hôtel-Dieu University Hospital

Nantes, France,

RECRUITING

Germany,

Bonn University Hospital, Institute for Experimental Hematology and Transfusion Medicine

Bonn, Germany,

RECRUITING

Germany,

Rhine-Ruhr coagulation center

Duisburg, Germany,

RECRUITING

Germany,

University Hospital Hamburg Eppendorf, II. Medical clinic and polyclinic

Hamburg, Germany,

RECRUITING

Italy,

"Pugliese Ciaccio" Hospital Company

Catanzaro, Italy,

RECRUITING

Italy,

"P. Giaccone" Polyclinic

Palermo, Italy,

RECRUITING

Serbia,

Clinical Center for Serbia

Belgrade, Serbia,

RECRUITING

Spain,

La Paz University Hospital

Madrid, Spain,

RECRUITING

Spain,

Virgen del Rocio University Hospital

Seville, Spain,

NOT YET RECRUITING

Switzerland,

Inselspital Bern

Bern, Switzerland,

RECRUITING

United Kingdom,

St. James's University Hospital

Leeds, United Kingdom,

NOT YET RECRUITING

Uruguay,

Pereira Rossell Hospital Center

Montevideo, Uruguay,