Clinical trial NCT05936580: Nuwiq Dosing and Outcomes In the ManagEment of Women/Girls With Haemophilia A Needing FVIII Treatment for Surgery
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)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Hemophilia A
Lead sponsor: Octapharma
Sponsor class: INDUSTRY
First posted: 2023-07-10
Enrollment: 28
Sex: FEMALE
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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

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

Eligibility 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

Primary outcomes:
measure: Overall haemostatic efficacy
timeFrame: During surgery and until completion of wound healing (e.g. removal of sutures, cessation of drainage, etc.) as defined by the investigator, during the study duration of 30 ± 3 days after the day of surgical procedure
Secondary outcomes:
measure: Intraoperative haemostatic efficacy
timeFrame: During surgery: From first skin incision to last suture
measure: Postoperative haemostatic efficacy
timeFrame: During surgery and until completion of wound healing (e.g. removal of sutures, cessation of drainage, etc.) as defined by the investigator, during the study duration of 30 ± 3 days after the day of surgical procedure
measure: Allogenic blood products
timeFrame: During surgery and until completion of wound healing (e.g. removal of sutures, cessation of drainage, etc.) as defined by the investigator, during the study duration of 30 ± 3 days after the day of surgical procedure
measure: FVIII plasma levels
timeFrame: ≤30 minutes before and 15-30 minutes after Nuwiq injection
measure: Perioperative haemostatic efficacy per WFH criteria
timeFrame: ≤30 minutes before and 15-30 minutes after Nuwiq injection
measure: Adverse events
timeFrame: From start of first Nuwiq injection to 30 ±3 days following the surgical procedure
measure: Thrombotic events
timeFrame: From start of first Nuwiq injection to 30 ±3 days following the surgical procedure
measure: FVIII inhibitor formation
timeFrame: From start of first Nuwiq injection to 30 ±3 days following the surgical procedure
Other outcomes:
Locations:
city: San Antonio
country: United States
facility: UT Health San Antonio
state: Texas
city: Helsinki
country: Finland
facility: Helsinki University Hospital,Coagulation Disorder Unit
city: Chambray-lès-Tours
country: France
facility: Avenue de la République
city: Nantes
country: France
facility: CHU de Nantes Hôtel-Dieu
city: Bonn
country: Germany
facility: Universitätsklinikum Bonn,Institut für Experimentelle Haematologie und Transfusionsmedizin
city: Duisburg
country: Germany
facility: Gerinnungszentrum Rhein-Ruhr
city: Hamburg
country: Germany
facility: Universitätsklinikum Hamburg Eppendorf,II. Medizinische Klinik und Poliklinik
city: Catanzaro
country: Italy
facility: Aziendo Ospedaliera "Puglieze Ciaccio"
city: Palermo
country: Italy
facility: Policlinico "P. Giaconne"
city: Belgrade
country: Serbia
facility: Clinical Center for Serbia
city: Madrid
country: Spain
facility: Hospital Universitario la Paz
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen del Rocio
city: Leeds
country: United Kingdom
facility: St. James's University Hospital
Study officials:
affiliation: Experimental Haematology and Transfusion Medicine, University Clinic Bonn
name: Johannes Oldenburg
role: PRINCIPAL_INVESTIGATOR
References: