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Clinical Trials in Germany / NCT03695978
Recruiting Observational

Efficacy, Safety & Utilisation of Nuwiq, Octanate and Wilate in Previously Untreated & Minimally Treated Haemophilia A Patients

NCT03695978 · tracked via the Priya Life Science Germany tracker
Sponsor
Phase
Observational
Started
2018-02-13
Last updated
2026-06-02

Condition(s) studied

Haemophilia A

Study summary

International, post-authorisation non-interventional study to evaluate real-life effectiveness, safety and utilisation patterns of Octapharma's FVIII concentrates Nuwiq, Octanate, and Wilate in previously untreated and minimally treated severe haemophilia A patients in routine clinical practice.

Eligibility

Sex
ALL
Min age
—
Max age
—
Healthy volunteers
No
Inclusion Criteria: * Male and female patients of any age and ethnicity * Severe haemophilia A (FVIII:C\<1%) * Decision to prescribe Octapharma's FVIII concentrate before enrollment into the study * Either * No previous treatment with FVIII concentrates or other blood products containing FVIII (PUPs) OR * Less than 5 Exposure Days (EDs) to FVIII concentrates or other blood products containing FVIII (MTPs), if * data are available on all previous treatment, AND * they did not develop an inhibitor at any time point, OR * they developed an inhibitor during treatment with an Octapharma FVIII concentrate AND continue treatment with THIS Octapharma FVIII concentrate (in the presence or absence of emicizumab). * Voluntarily given, fully informed written and signed consent obtained before any study-related data documentation is conducted (obtained from the patient's parent/legal guardian) Exclusion Criteria: * Diagnosis with a coagulation disorder other than haemophilia A * Concomitant treatment with any systemic immunosuppressive drug * Participation in an interventional clinical trial during the time period evaluated * Participation in another non-interventional study of Octapharma

Primary outcome measure(s)

Trial sites (59)

FacilityCityRegionStatus
University of Miami Miller School of Medicine Miami Florida Recruiting
Ochsner Clinic Foundation New Orleans Louisiana Active Not Recruiting
St. Louis University , 221 North Grand Boulevard St Louis Missouri Not Yet Recruiting
Cure 4 The Kids Foundation Children's Specialty Center Las Vegas Nevada Withdrawn
The University of Texas Health Science Center at San Antonio San Antonio Texas Not Yet Recruiting
CENIDOR Salta Argentina Active Not Recruiting
Azerbaijan State Advanced Training Institute for Doctors Hematology Department Scientific-Research Center of Hemophilia Baku Azerbaijan Withdrawn
Republican Scientific Center for Radiation Medicine and Human Ecology Homyel Belarus Withdrawn
Republican Scientific and Practical Centre of Children Oncology, Hematology and Immunology Minsk Belarus Recruiting
Hôpital Universitaire des Enfants Reine Fabiola Brussels Belgium Recruiting
Cliniques Universitaires Saint-Luc Brussels Belgium Recruiting
Cliniques Universitaires Saint-Luc Brussels Belgium Recruiting
McMaster University, Division of Pediatric Hematology/Oncology Room 3N27 Hamilton Ontario Withdrawn
Department of Hematology Research Research Transition Facility Edmonton Canada Completed
University Hospital Centre Zagreb Zagreb Croatia Recruiting
Tallinn Childrenś Hospital Clinic of Paediatric Department of Haematology and Oncology Tallinn Estonia Withdrawn
CENTRE HOSPITALIER UNIVERSITAIRE de BESANCON Besançon France Recruiting
The Centre Hospitalier Métropole Savoie Chambéry France Recruiting
CHRU Tours - Hôpital Trousseau Chambray-lès-Tours France Recruiting
Centre Régional de Traitement de l'hémophilie Le Mans France Recruiting
Hopital Simone Veil Groupement Hospitalier Eaubonne-Montmorency Montmorency France Recruiting
CHU Hotel Dieu, Centre de Traitment de l'Hemophilie Nantes France Recruiting
Hôspital Necker Enfants Malades Paris France Recruiting
CHRU Hopital Nord, Secretariat de pediatre, bat E niv +3 Saint-Priest-en-Jarez France Recruiting
Vivantes - Netzwerk für Gesundheit GmbH Klinikum im Friedrichshain Berlin Germany Active Not Recruiting
Institute of Experimental Haematology and Transfusion Medicine (IHT) University Clinic Bonn (AöR) Bonn Germany Recruiting
Coagulation Research Centre GmbH Duisburg Germany Recruiting
University Hospital Essen Essen Germany Active Not Recruiting
HZRM GmbH Frankfurt Germany Active Not Recruiting
Heim Pál National Pediatric Institute Department of Oncology and Hematology Budapest Hungary Recruiting
University of Debrecen Department of Pediatrics Debrecen Hungary Recruiting
Ospedale Pediatrico "Giovani XXIII" Bari Italy Recruiting
Policlinico Sant'Orsola Malpighi Bologna Italy Recruiting
Ospedale San Giacomo Castelfranco Veneto Italy Completed
Azienda Ospedaliera-Universitaria Policlinico "Vittorio Emanuele", Centro di Riferimento Regionale per la Prevenzione, Diagnosi e Cura delle Malattie Rare della Coagulazione nel Bambino e neel'Adulto. U.O.C Ematologia con trapianto di Midollo Osseo Catania Italy Recruiting
Azienda Ospedaliero Universitaria Careggi Florence Italy Recruiting
Ospedale Maggiore Policlinico Milan Italy Recruiting
Center for Thrombosis and Hemorrhagic Diseases, IRCCS Humanitas Research Hospital Milan Italy Recruiting
Centro Emofilia - AUO di Padova Padova Italy Withdrawn
Policlinico Umberto I Rome Italy Recruiting

+ 19 more sites — see the full list on the official registry below.

More Octapharma trials in Germany

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT03695978 on ClinicalTrials.gov ↗ ← All trials in Germany