Thinking of joining a study?

Register your interest

Become a volunteer?

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 : 2025-09
Estimated Primary Completion Date : 2025-12
Estimated Study Completion Date : 2025-12

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
  • 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 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
  • 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

NOT YET RECRUITING

United States, Texas

UT Health San Antonio

San Antonio, Texas, United States, 78229

RECRUITING

Finland,

Helsinki University Hospital,Coagulation Disorder Unit

Helsinki, Finland,

RECRUITING

France,

Avenue de la République

Chambray-East-Tours, France,

RECRUITING

France,

CHU de Nantes Hôtel-Dieu

Nantes, France,

RECRUITING

Germany,

University Hospital Bonn, Institute for Experimental Haematology and Transfusion Medicine

Bonn, Germany,

RECRUITING

Germany,

Coagulation center Rhein-Ruhr

Duisburg, Germany,

RECRUITING

Germany,

University Hospital Hamburg Eppendorf, II. Medical clinic and polyclinic

Hamburg, Germany,

RECRUITING

Italy,

"Pugliese Ciaccio" Hospital

Catanzaro, Italy,

RECRUITING

Italy,

Polyclinic "P. Giaccone"

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

Sevilla, Spain,

NOT YET RECRUITING

United Kingdom,

St. James's University Hospital

Leeds, United Kingdom,