A Long-term Study of ADYNOVI/ADYNOVATE in Participants With Haemophilia A
Running, not enrolling
Conditions studied: Hemophilia A
In brief
The main aim of this study is to check for long-term side effects from ADYNOVI/ADYNOVATE prophylaxis in participants with haemophilia A when used under standard clinical practice in the real-world clinical setting.
Key facts
- Study ID
- NCT04158934
- Run by
- Baxalta now part of Shire
- People needed
- 207
- Starts
- 2020-07-09
- Expected to finish
- 2030-02-28
- Last updated by the study team
- 2026-02-18
Who can join
Age: any. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- UF Health Shands Hospital — Gainesville, Florida, United States
- SHAT of Oncohaematology Diseases — Sofia, Bulgaria
- Clinical Hospital Sveti Duh — Zagreb, Croatia
- University hospital centre Zagreb — Zagreb, Croatia
- University hospital centre Zagreb — Zagreb, Croatia
- Fakultni nemocnice v Motole — Prague, Czechia
- Krajska zdravotni a.s. - Masarykova nemocnice v Usti nad Labem o.z. — Ústí nad Labem, Czechia
- SRH Kurpfalzkrankenhaus Heidelberg GmbH — Heidelberg, Baden-Wurttemberg, Germany
- Vivantes Klinikum im Friedrichshain — Berlin, Germany
- Universitaetsklinikum Bonn AoeR — Bonn, Germany
- Werlhof-Institut GmbH — Hanover, Germany
- Heim Pal Orszagos Gyermekgyogyaszati Intezet — Budapest, Hungary
- Eszak-Pesti Centrumkorhaz - Honvedkorhaz — Budapest, Hungary
- Debreceni Egyetem — Debrecen, Hungary
- Mohacsi Korhaz — Mohács, Hungary
- Szabolcs-Szatmar-Bereg Varmegyei Oktatokorhaz — Nyíregyháza, Hungary
- Pecsi Tudomanyegyetem Klinikai Kozpont — Pécs, Hungary
- Fondazione IRCCS CA' Granda Ospedale Maggiore Policlinico — Milan, Italy
- Azienda Ospedaliera Universitaria Policlinico Umberto I - Università di Roma La Sapienza — Roma, Italy
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS — Roma, Italy
- University Medical Centre Groningen-UMCG — Groningen, Netherlands
- Kyung Hee University Hospital at Gangdong — Seoul, South Korea
- Ulsan University Hospital — Ulsan, South Korea
- Hospital Universitari Son Espases — Palma de Mallorca, Balearic Islands, Spain
- Hospital Universitari Vall d'Hebron — Barcelona, Spain
Full record on ClinicalTrials.gov
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