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Hemophilia a study observes how new patients respond to factor VIII in daily practice

NCT ID NCT03695978

Knowledge-focused Sponsor: Octapharma Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study is observing how well three Factor VIII concentrates (Nuwiq, Octanate, Wilate) work in real-world settings for people with severe hemophilia A who have had little or no prior treatment. Researchers will track bleeding rates and side effects in about 200 participants of any age. The goal is to understand how these treatments perform outside of controlled clinical trials.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Factor VIII concentrates (Nuwiq, Octanate, Wilate)
What this could lead to
If successful, this study could provide real-world data on how well these FVIII concentrates work and their safety in young, untreated hemophilia A patients.
What could go wrong
This is an observational study, not a controlled trial, so results may be influenced by factors other than the treatment. It does not test a new drug, but rather gathers routine clinical data.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 200 people

The number the study aims to enrol. It can still change while the study runs.

Started

Feb 2018

Expected to finish

Jun 2030

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

A total of 200 patients, either previously untreated patients (PUPs) or minimally treated patients (MTPs), are planned to be documented in the study

Ages

Children (under 18), adults (18 to 64) and older adults (65 and over)

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

hemophilia A severe hemophilia A

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Haemophilia A

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    39 sites in 12 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Azerbaijan State Advanced Training Institute for Doctors Hematology Department Scientific-Research Center of Hemophilia

    WITHDRAWN

    Baku, AZ1012, Azerbaijan

  • 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

    RECRUITING

    Catania, 95123, Italy

  • Azienda Ospedaliero Universitaria Careggi

    RECRUITING

    Florence, 50134, Italy

  • Birmingham Children's Hospital NHS Foundation Trust

    WITHDRAWN

    Birmingham, B46NH, United Kingdom

  • C.tro Emofilia A.O. Città della salute e della scienza di Torino, Ospedale Regina Margherita

    RECRUITING

    Torino, Italy

  • CENIDOR

    ACTIVE_NOT_RECRUITING

    Salta, Argentina

  • CENTRE HOSPITALIER UNIVERSITAIRE de BESANCON

    RECRUITING

    Besançon, France

  • CHRU Hopital Nord, Secretariat de pediatre, bat E niv +3

    RECRUITING

    Saint-Priest-en-Jarez, 42270, France

  • CHRU Tours - Hôpital Trousseau

    RECRUITING

    Chambray-lès-Tours, France

  • CHU Hotel Dieu, Centre de Traitment de l'Hemophilie

    RECRUITING

    Nantes, 44093, France

  • Center for Thrombosis and Hemorrhagic Diseases, IRCCS Humanitas Research Hospital

    RECRUITING

    Milan, Italy

  • Centre Régional de Traitement de l'hémophilie

    RECRUITING

    Le Mans, France

  • Centro Emofilia - AUO di Padova

    WITHDRAWN

    Padova, Italy

  • Children's Hospital Affiliate of Vilnius Universtity Hospital Santaros Klinikos

    RECRUITING

    Vilnius, LT-08406, Lithuania

  • Cliniques Universitaires Saint-Luc

    RECRUITING

    Brussels, 1200, Belgium

  • Cliniques Universitaires Saint-Luc

    RECRUITING

    Brussels, 1200, Belgium

  • Coagulation Research Centre GmbH

    RECRUITING

    Duisburg, 47051, Germany

  • Cure 4 The Kids Foundation Children's Specialty Center

    WITHDRAWN

    Las Vegas, Nevada, 89109, United States

  • Department of Hematology Research Research Transition Facility

    COMPLETED

    Edmonton, T6G 2V2, Canada

  • Great Ormond Street Hospital for Children NHS Trust, Haemophilia Centre

    RECRUITING

    London, WC1N 3JH, United Kingdom

  • HRU Malaga

    NOT_YET_RECRUITING

    Málaga, Spain

  • HZRM GmbH

    ACTIVE_NOT_RECRUITING

    Frankfurt, Germany

  • Heim Pál National Pediatric Institute Department of Oncology and Hematology

    RECRUITING

    Budapest, 1089, Hungary

  • Hopital Simone Veil Groupement Hospitalier Eaubonne-Montmorency

    RECRUITING

    Montmorency, 95160, France

  • Hospital General Universitario de Alicante Hematología y Hemoterapia

    RECRUITING

    Alicante, 03010, Spain

  • Hospital General de Occidente, Unidad de Hemato-Oncologia Pediatric, Av. Zoquipan 1050, Col Seattle, , Col Seattle

    RECRUITING

    Jalisco, Mexico

  • Hospital Infantil de Morelia Eva Sámano de López Mateos

    NOT_YET_RECRUITING

    Morelia, Mexico

  • Hospital Universitari Vall D'Hebrón, Unitat d'Hemofilia

    RECRUITING

    Barcelona, 02035, Spain

  • Hospital Universitario Dr. José Eleuterio Gonzalez S/N

    NOT_YET_RECRUITING

    Nuevo León, Mexico

  • Hospital Universitario y Politécnico La Fe

    ACTIVE_NOT_RECRUITING

    Valencia, Spain

  • Hôpital Universitaire des Enfants Reine Fabiola

    RECRUITING

    Brussels, 1020, Belgium

  • Hôspital Necker Enfants Malades

    RECRUITING

    Paris, France

  • Institute of Experimental Haematology and Transfusion Medicine (IHT) University Clinic Bonn (AöR)

    RECRUITING

    Bonn, 53127, Germany

  • Istanbul University Faculty of Medicine

    WITHDRAWN

    Fatih, Turkey (Türkiye)

  • John Radcliffe Hospital, Oxford University Hospitals, NHS Foundation Trust

    RECRUITING

    Headington, Oxford, OX3 9DU, United Kingdom

  • McMaster University, Division of Pediatric Hematology/Oncology Room 3N27

    WITHDRAWN

    Hamilton, Ontario, 1800NOCLOTS, Canada

  • Moscow State Government-financed Public Healthcare Institution "Morozovskaya Children Clinical Hospital of Moscow Healthcare Department"

    WITHDRAWN

    Moscow, 119049, Russia

  • Newcastle Haemophilia Comprehensive Care Centre, Royal Victoria Infirmary

    RECRUITING

    Newcastle upon Tyne, NE1 4LP, United Kingdom

  • Ochsner Clinic Foundation

    ACTIVE_NOT_RECRUITING

    New Orleans, Louisiana, 70121, United States

  • Ospedale Maggiore Policlinico

    RECRUITING

    Milan, 920122, Italy

  • Ospedale Pediatrico "Giovani XXIII"

    RECRUITING

    Bari, Italy

  • Ospedale Regina Margherita

    WITHDRAWN

    Turin, 10126, Italy

  • Ospedale San Giacomo

    COMPLETED

    Castelfranco Veneto, 31033, Italy

  • Policlinico Sant'Orsola Malpighi

    RECRUITING

    Bologna, 40138, Italy

  • Policlinico Umberto I

    RECRUITING

    Rome, 00161, Italy

  • Republican Scientific Center for Radiation Medicine and Human Ecology

    WITHDRAWN

    Homyel, 246040, Belarus

  • Republican Scientific and Practical Centre of Children Oncology, Hematology and Immunology

    RECRUITING

    Minsk, 223053, Belarus

  • SMO and Scientific Services S.A.P.P de C.V

    NOT_YET_RECRUITING

    Nuevo León, Mexico

  • Saint-Petersburg State Budget Healthcare Institution "City Out-patient Clinical # 37"

    WITHDRAWN

    Saint Petersburg, 191186, Russia

  • St. Louis University , 221 North Grand Boulevard

    NOT_YET_RECRUITING

    St Louis, Missouri, 63103, United States

  • Tallinn Childrenś Hospital Clinic of Paediatric Department of Haematology and Oncology

    WITHDRAWN

    Tallinn, 13419, Estonia

  • The Centre Hospitalier Métropole Savoie

    RECRUITING

    Chambéry, 31125 73011, France

  • The University of Texas Health Science Center at San Antonio

    NOT_YET_RECRUITING

    San Antonio, Texas, 78712, United States

  • Universitary Hospital Son Espases (Hematology Service)

    ACTIVE_NOT_RECRUITING

    Palma de Mallorca, Spain

  • University Hospital Centre Zagreb

    RECRUITING

    Zagreb, Croatia

  • University Hospital Essen

    ACTIVE_NOT_RECRUITING

    Essen, Germany

  • University of Debrecen Department of Pediatrics

    RECRUITING

    Debrecen, 4032, Hungary

  • University of Miami Miller School of Medicine

    RECRUITING

    Miami, Florida, 33136, United States

  • Vivantes - Netzwerk für Gesundheit GmbH Klinikum im Friedrichshain

    ACTIVE_NOT_RECRUITING

    Berlin, 10249, Germany

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