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Hemophilia drug safety under the microscope: real-world study launched

NCT ID NCT04158934

Knowledge-focused Sponsor: Baxalta now part of Shire Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study follows 207 people with hemophilia A who are already taking ADYNOVI/ADYNOVATE to prevent bleeding. Researchers want to see if any long-term side effects appear during normal use. The goal is to gather safety information, not to test if the drug works.

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

207 people

The number who actually took part.

Started

Jul 2020

Expected to finish

Feb 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

Up to 200 participants with haemophilia A will be enrolled. The study will be conducted in European, North American and Asian countries.

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 * Signed informed consent obtained from participant and/or legally authorised representative before any study related activities (any procedure related to recording of data according to the protocol). * Participant at any age with haemophilia A prescribed ADYNOVI/ADYNOVATE prophylaxis. * Negative factor VIII (FVIII) inhibitor test at study entry. * Decision to initiate treatment with commercially available ADYNOVI/ADYNOVATE has been made by the participant and/or legally authorised representative and the treating physician before and independently from the decision to include the participant in this study. Exclusion Criteria * Previous participation in this study. Participation is defined as signed informed consent. * Known or suspected hypersensitivity to ADYNOVI/ADYNOVATE or related products. * Mental incapacity, unwillingness or other barriers precluding adequate understanding or cooperation.

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Conditions

The condition(s) this trial relates to.

hemophilia A

As listed by the trial registrant

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

Hemophilia A

Contacts and locations

Locations

  • Azienda Ospedaliera Universitaria Policlinico Umberto I - Università di Roma La Sapienza

    Roma, 00161, Italy

  • Chang Gung Memorial Hospital, Linkou

    Taoyuan, 333, Taiwan

  • Clinical Hospital Sveti Duh

    Zagreb, 10000, Croatia

  • Debreceni Egyetem

    Debrecen, 4032, Hungary

  • Eszak-Pesti Centrumkorhaz - Honvedkorhaz

    Budapest, 1134, Hungary

  • Fakultni nemocnice v Motole

    Prague, 150 06, Czechia

  • Fondazione IRCCS CA' Granda Ospedale Maggiore Policlinico

    Milan, 20122, Italy

  • Fondazione Policlinico Universitario Agostino Gemelli IRCCS

    Roma, 00168, Italy

  • Heim Pal Orszagos Gyermekgyogyaszati Intezet

    Budapest, 1089, Hungary

  • Hospital Regional Universitario de Malaga

    Málaga, 29010, Spain

  • Hospital Universitari Son Espases

    Palma de Mallorca, Balearic Islands, 07120, Spain

  • Hospital Universitari Vall d'Hebron

    Barcelona, 08035, Spain

  • Hospital Universitario La Paz

    Madrid, 28046, Spain

  • Hospital Universitario de Gran Canaria Dr. Negrin

    Las Palmas, 35010, Spain

  • King Chulalongkorn Memorial Hospital

    Bangkok, 10330, Thailand

  • Krajska zdravotni a.s. - Masarykova nemocnice v Usti nad Labem o.z.

    Ústí nad Labem, 40113, Czechia

  • Kyung Hee University Hospital at Gangdong

    Seoul, 134-727, South Korea

  • MacKay Memorial Hospital_Taipei Branch

    Taipei, 10449, Taiwan

  • Maharaj Nakorn Chiang Mai Hospital

    Chiang Mai, 50200, Thailand

  • Mohacsi Korhaz

    Mohács, 7700, Hungary

  • Pecsi Tudomanyegyetem Klinikai Kozpont

    Pécs, 7624, Hungary

  • Phramongkutklao Hospital

    Bangkok, 10400, Thailand

  • SHAT of Oncohaematology Diseases

    Sofia, 1527, Bulgaria

  • SRH Kurpfalzkrankenhaus Heidelberg GmbH

    Heidelberg, Baden-Wurttemberg, D-69123, Germany

  • Sahlgrenska Universitetssjukhuset

    Gothenburg, 41345, Sweden

  • Siriraj Hospital

    Bangkoknoi Bangkok, 10700, Thailand

  • Szabolcs-Szatmar-Bereg Varmegyei Oktatokorhaz

    Nyíregyháza, 4400, Hungary

  • Tri-Service General Hospital

    Taipei, 11490, Taiwan

  • UF Health Shands Hospital

    Gainesville, Florida, 32610, United States

  • Ulsan University Hospital

    Ulsan, 44033, South Korea

  • Universitaetsklinikum Bonn AoeR

    Bonn, 53127, Germany

  • University Medical Centre Groningen-UMCG

    Groningen, 9713 GZ, Netherlands

  • University hospital centre Zagreb

    Zagreb, 10000, Croatia

  • University hospital centre Zagreb

    Zagreb, 1000, Croatia

  • Vivantes Klinikum im Friedrichshain

    Berlin, 10249, Germany

  • Werlhof-Institut GmbH

    Hanover, 30159, Germany

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