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Recombinant factor VIII for the prevention of bleeding in women/girls with haemophilia A undergoing major surgery
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Nuwiq | Experimental | All patients receiving Nuwiq (recombinant FVIII). Nuwiq will be administered intravenously in accordance with the relevant prescribing information. Treatment will be repeated as necessary every 8-24 hours until adequate wound healing, then - if required - for at least another 7 days to maintain FVIII plasma levels of 30-60 IU/dL. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nuwiq | Drug | Nuwiq is a purified B-domain-deleted FVIII glycoprotein synthesised by a genetically engineered human embryonic kidney cell line (HEK 293F). |
|
| Measure | Description | Time Frame |
|---|---|---|
| Overall haemostatic efficacy | Overall haemostatic efficacy of treatment measured as binary "success" or "failure". The overall perioperative haemostatic efficacy of Nuwiq will be adjudicated by an Independent Data Monitoring Committee (IDMC) and determined using a composite assessment algorithm that considers the surgeon's assessment of intraoperative haemostatic efficacy and the investigator's assessment of postoperative haemostatic efficacy to classify the overall haemostatic efficacy as success or failure. | 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 | Description | Time Frame |
|---|---|---|
| Intraoperative haemostatic efficacy | Assessment of intraoperative haemostatic efficacy of Nuwiq using a 4-point ordinal scale: Excellent: Intraoperative blood loss was lower than or equal to the average expected blood loss for the type of procedure performed in a patient with normal haemostasis and of the same sex, age, and stature Good: Intraoperative blood loss was higher than the average expected blood loss but lower or equal to the maximal expected blood loss for the type of procedure in a patient with normal haemostasis. Moderate: Intraoperative blood loss was higher than the maximum expected blood loss for the type of procedure performed in a patient with normal haemostasis, but haemostasis was controlled. None: Haemostasis was uncontrolled, necessitating a change in the clotting factor replacement regimen. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Cristina Solomon | Contact | +41795859042 | cristina.solomon@octapharma.com |
| Name | Affiliation | Role |
|---|---|---|
| Johannes Oldenburg | Experimental Haematology and Transfusion Medicine, University Clinic Bonn | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UT Health San Antonio | Recruiting | San Antonio | Texas | 78229 | United States | |
| Helsinki University Hospital,Coagulation Disorder Unit |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39624518 | Derived | Marquardt N, Langer F, Holstein K, Alvarez Roman MT, Nunez Vazquez R, Miljic P, Drillaud N, Ardillon L, Lehtinen AE, Santoro RC, Napolitano M, Siragusa S, Gidley G, Jansen M, Knaub S, Oldenburg J. Design of an international, phase IV, open-label study of simoctocog alfa in women/girls with hemophilia A undergoing surgery (NuDIMENSION). Ther Adv Hematol. 2024 Dec 1;15:20406207241300040. doi: 10.1177/20406207241300040. eCollection 2024. |
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| During surgery: From first skin incision to last suture |
| Postoperative haemostatic efficacy | Assessment of postoperative haemostatic efficacy of Nuwiq using a 4-point ordinal scale: Excellent: No postoperative bleeding or oozing that was not due to complications of surgery. All postoperative bleeding (due to complications of surgery) was controlled with Nuwiq as anticipated for the type of procedure. Good: No postoperative bleeding or oozing that was not due to complications of surgery. Control of postoperative bleeding due to complications of surgery required increased dosing with Nuwiq or additional injections not originally anticipated for the type of procedure. Moderate: Some postoperative bleeding and oozing that was not due to complications of surgery. Control of postoperative bleeding required increased dosing with Nuwiq or additional injections not originally anticipated for the type of procedure. None: Extensive uncontrolled postoperative bleeding and oozing. | 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 |
| Allogenic blood products | Use of allogeneic blood products (red blood cells, platelets, and other blood products) | 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 |
| FVIII plasma levels | Perioperative plasma levels | ≤30 minutes before and 15-30 minutes after Nuwiq injection |
| Perioperative haemostatic efficacy per WFH criteria | Assessed using 4-point scale recommended by WFH: Excellent: Intra- and post-operative blood loss similar to non-haemophilic patient. No extra doses of FVIII/bypassing agents needed Good: Intra- and/or post-operative blood loss slightly increased over expectation for non-haemophilic patient, but judged to be clinically insignificant. No extra doses of FVIII/bypassing agents needed Fair: Intra- and/or post-operative blood loss increased over expectation for the non-haemophilic patient, and additional treatment needed. Extra dose of FVIII/bypassing agents needed, or increased blood component of anticipated transfusion requirement Poor: Significant intra- and/or post-operative blood loss substantially increased over expectation for non-haemophilic patient, requires intervention not explained by medical issue other than haemophilia. Unexpected hypotension, unexpected transfer to ICU due to bleeding, substantially increased blood component of the anticipated transfusion requirement | ≤30 minutes before and 15-30 minutes after Nuwiq injection |
| Adverse events | Incidence of adverse events recorded during the full study period | From start of first Nuwiq injection to 30 ±3 days following the surgical procedure |
| Thrombotic events | Incidence of thrombotic events during the study | From start of first Nuwiq injection to 30 ±3 days following the surgical procedure |
| FVIII inhibitor formation | Incidence of FVIII inhibitor formation | From start of first Nuwiq injection to 30 ±3 days following the surgical procedure |
| Recruiting |
| Helsinki |
| Finland |
| Avenue de la République | Recruiting | Chambray-lès-Tours | France |
| CHU de Nantes Hôtel-Dieu | Recruiting | Nantes | France |
| Chu de Strasbourg | Not yet recruiting | Stasbourg | France |
| Universitätsklinikum Bonn,Institut für Experimentelle Haematologie und Transfusionsmedizin | Recruiting | Bonn | Germany |
| Gerinnungszentrum Rhein-Ruhr | Recruiting | Duisburg | Germany |
| Universitätsklinikum Hamburg Eppendorf,II. Medizinische Klinik und Poliklinik | Recruiting | Hamburg | Germany |
| Aziendo Ospedaliera "Puglieze Ciaccio" | Recruiting | Catanzaro | Italy |
| Policlinico "P. Giaconne" | Recruiting | Palermo | Italy |
| Clinical Center for Serbia | Recruiting | Belgrade | Serbia |
| Hospital Universitario la Paz | Recruiting | Madrid | Spain |
| Hospital Universitario Virgen del Rocio | Recruiting | Seville | Spain |
| Insel Spital Bern | Not yet recruiting | Bern | Switzerland |
| St. James's University Hospital | Recruiting | Leeds | United Kingdom |
| Centro Hospitalario Pereira Rossell | Not yet recruiting | Montevideo | Uruguay |
| ID | Term |
|---|---|
| D006467 | Hemophilia A |
| ID | Term |
|---|---|
| D025861 | Blood Coagulation Disorders, Inherited |
| D001778 | Blood Coagulation Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D020147 | Coagulation Protein Disorders |
| D006474 | Hemorrhagic Disorders |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
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| ID | Term |
|---|---|
| D005169 | Factor VIII |
| ID | Term |
|---|---|
| D001779 | Blood Coagulation Factors |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D011498 | Protein Precursors |
| D001685 | Biological Factors |
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