SYF6417f55652c94962aefb32bd40c1a803Registry ID: 2022-502061-17-00|RecruitingPhase 4
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interventional
N/A
8 countries
12
To evaluate the overall perioperative haemostatic efficacy of Nuwiq in women/girls with haemophilia A undergoing major surgery.
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January 31, 2023
Actual (reported)The overall haemostatic efficacy of Nuwiq in women/girls with haemophilia A undergoing major surgery assessed at the end of surgery by the surgeon and at the end of the POP by the investigator. Overall haemostatic efficacy will be adjudicated by the IDMC, using a pre-defined algorithm. The end of the POP for a surgical event will be defined as completion of wound healing, as defined by the investigator. Subsequent dosing of Nuwiq, if necessary, will not included in the assessment of efficacy
Assessment of intraoperative haemostatic efficacy of Nuwiq using a 4-point ordinal scale
Assessment of postoperative haemostatic efficacy of Nuwiq using a 4-point ordinal scale
Perioperative FVIII plasma levels immediately before (≤30 minutes) and after (15-30 minutes) Nuwiq injections
Perioperative haemostatic efficacy assessed using the 4-point scale recommended by the WFH (1)
Incidence of adverse events (AEs)
CF Clinical Hospital
Cluj-Napoca, 400015, Romania
University Hospital Virgen Del Rocio S.L.
Sevilla, 41013, Spain
Hospital Universitario La Paz
Madrid, 28046, Spain
Sigurd Knaub, PhD, SVP CRD Haematology
First Submitted
January 31, 2023
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Source: European Medicines Agency (EMA), Clinical Trials Information System (CTIS). Original record and public documents are available on CTIS.
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Source retrieved:
An Open Study to Investigate the Safety and Efficacy of Optivate® in Haemophilia A Patients Undergoing Surgery.
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HUS Helsinki University Hospital
Helsinki, 00290, Finland
Les Hopitaux Universitaires De Strasbourg
Strasbourg Cedex 2, 67098, France
Centre Hospitalier Universitaire De Nantes
Nantes, 44000, France
Centre Hospitalier Regional Universitaire De Tours
Tours, 37000, France
Azienda Sanitaria Universitaria Integrata Del Trentino
Trento, 38122, Italy
Azienda Ospedaliera Pugliese Ciaccio
Catanzaro, 88100, Italy
Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone
Palermo, 90127, Italy
University Medical Center Hamburg-Eppendorf
Hamburg, 20251, Germany
Universitaetsklinikum Bonn AöR
Bonn, 53127, Germany