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NCT03695978Recruiting

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

Practical Utilisation of Octapharma FVIII Concentrates in Previously Untreated & Minimally Treated Haemophilia A Patients Entering Routine Clinical Treatment With Nuwiq, Octanate or Wilate - Efficacy & Safety Observational Study-Protect-NOW

Source: ClinicalTrials.gov · Last updated 2 Jun 2026

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Study type
Observational
Enrollment
200 (estimated)
First submitted
3 Oct 2018
Start date
13 Feb 2018
Primary completion date
Jun 2030
Lead sponsor
Octapharma
Diseases
Haemophilia
NCT number
NCT03695978

What you commit to

  • Study type: Observational
  • Planned participants: 200
  • From 13 Feb 2018 to the primary completion date, Jun 2030
  • 58 sites in 18 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Concomitant treatment with any systemic immunosuppressive drug

Other illness

  • Diagnosis with a coagulation disorder other than haemophilia A

Other

  • Participation in an interventional clinical trial during the time period evaluated
  • Participation in another non-interventional study of Octapharma

Who the study is looking for

  • 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)

Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (58)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
CENIDOR
Coordinator of this site? Confirm its status
SaltaArgentinaActive, not recruiting
Azerbaijan State Advanced Training Institute for Doctors Hematology Department Scientific-Research Center of Hemophilia
Coordinator of this site? Confirm its status
BakuAzerbaijanWithdrawn
Cliniques universitaires Saint-Luc
Coordinator of this site? Confirm its status
BrusselsBelgiumRecruiting
Hòpital Universitaire des Enfants Reine Fabiola
Coordinator of this site? Confirm its status
BrusselsBelgiumRecruiting
Republican Scientific Center for Radiation Medicine and Human Ecology
Coordinator of this site? Confirm its status
HomyelBelarusWithdrawn
Republican Scientific and Practical Centre of Children Oncology, Hematology and Immunology
Coordinator of this site? Confirm its status
MinskBelarusRecruiting
Department of Hematology Research Research Transition Facility
Coordinator of this site? Confirm its status
EdmontonCanadaCompleted
McMaster University, Division of Pediatric Hematology/Oncology Room 3N27
Coordinator of this site? Confirm its status
HamiltonCanadaWithdrawn
Vivantes - Netzwerk für Gesundheit GmbH Klinikum im Friedrichshain
Coordinator of this site? Confirm its status
BerlinGermanyActive, not recruiting
Institute of Experimental Haematology and Transfusion Medicine (IHT) University Clinic Bonn (AöR)
Coordinator of this site? Confirm its status
BonnGermanyRecruiting
Coagulation Research Centre GmbH
Coordinator of this site? Confirm its status
DuisburgGermanyRecruiting
University Hospital Essen
Coordinator of this site? Confirm its status
EssenGermanyActive, not recruiting
HZRM GmbH
Coordinator of this site? Confirm its status
FrankfurtGermanyActive, not recruiting
Tallinn Childrenś Hospital Clinic of Paediatric Department of Haematology and Oncology
Coordinator of this site? Confirm its status
TallinnEstoniaWithdrawn
Hospital General Universitario de Alicante Hematología y Hemoterapia
Coordinator of this site? Confirm its status
AlicanteSpainRecruiting
Hospital Universitari Vall D'Hebrón, Unitat d'Hemofilia
Coordinator of this site? Confirm its status
BarcelonaSpainRecruiting
HRU Malaga
Coordinator of this site? Confirm its status
MálagaSpainNot yet recruiting
Universitary Hospital Son Espases (Hematology Service)
Coordinator of this site? Confirm its status
Palma de MallorcaSpainActive, not recruiting
Hospital Universitario Y Politecnico La Fe
Coordinator of this site? Confirm its status
ValenciaSpainActive, not recruiting
Centre Hospitalier Universitaire de Besançon
Coordinator of this site? Confirm its status
BesançonFranceRecruiting
The Centre Hospitalier Métropole Savoie
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ChambéryFranceRecruiting
CHRU Tours - Hopital Trousseau
Coordinator of this site? Confirm its status
Chambray-lès-ToursFranceRecruiting
Centre Régional de Traitement de l'hémophilie
Coordinator of this site? Confirm its status
Le MansFranceRecruiting
Hopital Simone Veil Groupement Hospitalier Eaubonne-Montmorency
Coordinator of this site? Confirm its status
MontmorencyFranceRecruiting
CHU Hotel Dieu, Centre de Traitment de l'Hemophilie
Coordinator of this site? Confirm its status
NantesFranceRecruiting
Hôspital Necker Enfants Malades
Coordinator of this site? Confirm its status
ParisFranceRecruiting
CHRU Hopital Nord, Secretariat de pediatre, bat E niv +3
Coordinator of this site? Confirm its status
Saint-Priest-en-JarezFranceRecruiting
Birmingham Children's Hospital NHS Foundation Trust
Coordinator of this site? Confirm its status
BirminghamUnited KingdomWithdrawn
John Radcliffe Hospital, Oxford University Hospitals, NHS Foundation Trust
Coordinator of this site? Confirm its status
HeadingtonUnited KingdomRecruiting
Great Ormond Street Hospital for Children NHS Trust, Haemophilia Centre
Coordinator of this site? Confirm its status
LondonUnited KingdomRecruiting
Newcastle Haemophilia Comprehensive Care Centre, Royal Victoria Infirmary
Coordinator of this site? Confirm its status
Newcastle upon TyneUnited KingdomRecruiting
University Hospital Centre Zagreb
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ZagrebCroatiaRecruiting
Heim Pál National Pediatric Institute Department of Oncology and Hematology
Coordinator of this site? Confirm its status
BudapestHungaryRecruiting
University of Debrecen Department of Pediatrics
Coordinator of this site? Confirm its status
DebrecenHungaryRecruiting
Ospedale Pediatrico "Giovani XXIII"
Coordinator of this site? Confirm its status
BariItalyRecruiting
Policlinico Sant'Orsola-Malpighi
Coordinator of this site? Confirm its status
BolognaItalyRecruiting
Ospedale San Giacomo
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Castelfranco VenetoItalyCompleted
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
Coordinator of this site? Confirm its status
CataniaItalyRecruiting
Azienda Ospedaliero-Universitaria Careggi
Coordinator of this site? Confirm its status
FlorenceItalyRecruiting
Ospedale Maggiore Policlinico
Coordinator of this site? Confirm its status
MilanItalyRecruiting
Center for Thrombosis and Hemorrhagic Diseases, IRCCS Humanitas Research Hospital
Coordinator of this site? Confirm its status
MilanItalyRecruiting
Centro Emofilia - AUO di Padova
Coordinator of this site? Confirm its status
PadovaItalyWithdrawn
Policlinico Umberto I
Coordinator of this site? Confirm its status
RomeItalyRecruiting
C.tro Emofilia A.O. Città della salute e della scienza di Torino, Ospedale Regina Margherita
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TorinoItalyRecruiting
Ospedale Regina Margherita
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TurinItalyWithdrawn
Children's Hospital Affiliate of Vilnius Universtity Hospital Santaros Klinikos
Coordinator of this site? Confirm its status
VilniusLithuaniaRecruiting
Hospital General de Occidente, Unidad de Hemato-Oncologia Pediatric, Av. Zoquipan 1050, Col Seattle, , Col Seattle
Coordinator of this site? Confirm its status
JaliscoMexicoRecruiting
Hospital Infantil de Morelia Eva Sámano de López Mateos
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MoreliaMexicoNot yet recruiting
SMO and Scientific Services S.A.P.P de C.V
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Nuevo LeónMexicoNot yet recruiting
Hospital Universitario Dr. José Eleuterio Gonzalez S/N
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Nuevo LeónMexicoNot yet recruiting
Moscow State Government-financed Public Healthcare Institution "Morozovskaya Children Clinical Hospital of Moscow Healthcare Department"
Coordinator of this site? Confirm its status
MoscowRussiaWithdrawn
Saint-Petersburg State Budget Healthcare Institution "City Out-patient Clinical # 37"
Coordinator of this site? Confirm its status
Saint PetersburgRussiaWithdrawn
Cure 4 The Kids Foundation Children's Specialty Center
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Las VegasUnited StatesWithdrawn
University of Miami Miller School of Medicine
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MiamiUnited StatesRecruiting
Ochsner Clinic Foundation
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New OrleansUnited StatesActive, not recruiting
The University of Texas Health Science Center at San Antonio
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San AntonioUnited StatesNot yet recruiting
St. Louis University , 221 North Grand Boulevard
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St LouisUnited StatesNot yet recruiting
Istanbul University Faculty of Medicine
Coordinator of this site? Confirm its status
FatihTurkey (Türkiye)Withdrawn

This page is information, not medical advice. Discuss any trial with your doctor.