NCT04158934Active, not recruiting
A Long-term Study of ADYNOVI/ADYNOVATE in Participants With Haemophilia A
Evaluation of Long-term Safety of ADYNOVI/ADYNOVATE (Antihaemophilic Factor [Recombinant] PEGylated, Rurioctocog Alfa Pegol) in Patients With Haemophilia A - An ADYNOVI/ADYNOVATE Post-Authorisation Safety Study (PASS)
Source: ClinicalTrials.gov · Last updated 18 Feb 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Study type
- Observational
- Enrollment
- 207 (actual)
- First submitted
- 14 Oct 2019
- Start date
- 9 Jul 2020
- Primary completion date
- 28 Feb 2030
- Lead sponsor
- Baxalta now part of Shire
- Diseases
- Haemophilia
- NCT number
- NCT04158934
What you commit to
- Study type: Observational
- Participants enrolled: 207
- From 9 Jul 2020 to the primary completion date, 28 Feb 2030
- 35 sites in 13 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
- Previous participation in this study. Participation is defined as signed informed consent.
Other illness
- Known or suspected hypersensitivity to ADYNOVI/ADYNOVATE or related products.
Other
- Mental incapacity, unwillingness or other barriers precluding adequate understanding or cooperation.
Who the study is looking for
- 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.
Sex: All · Does not accept healthy volunteers
Sites (35)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| SHAT of Oncohaematology Diseases Coordinator of this site? Confirm its status | Sofia | Bulgaria | Unknown status |
| Fakultni nemocnice v Motole Coordinator of this site? Confirm its status | Prague | Czechia | Unknown status |
| Krajska zdravotni, a.s. - Masarykova nemocnice v Usti nad Labem, o.z. Coordinator of this site? Confirm its status | Ústí nad Labem | Czechia | Unknown status |
| Vivantes Klinikum im Friedrichshain Coordinator of this site? Confirm its status | Berlin | Germany | Unknown status |
| Universitaetsklinikum Bonn AoeR Coordinator of this site? Confirm its status | Bonn | Germany | Unknown status |
| Werlhof-Institut GmbH Coordinator of this site? Confirm its status | Hanover | Germany | Unknown status |
| SRH Kurpfalzkrankenhaus Heidelberg GmbH Coordinator of this site? Confirm its status | Heidelberg | Germany | Unknown status |
| Hospital Universitari Vall d'Hebron Coordinator of this site? Confirm its status | Barcelona | Spain | Unknown status |
| Hospital Universitario De Gran Canaria Dr. Negrin Coordinator of this site? Confirm its status | Las Palmas | Spain | Unknown status |
| Hospital Universitario La Paz Coordinator of this site? Confirm its status | Madrid | Spain | Unknown status |
| Hospital Regional Universitario de Malaga Coordinator of this site? Confirm its status | Málaga | Spain | Unknown status |
| Hospital Universitari Son Espases Coordinator of this site? Confirm its status | Palma de Mallorca | Spain | Unknown status |
| University Hospital Centre Zagreb Coordinator of this site? Confirm its status | Zagreb | Croatia | Unknown status |
| Clinical Hospital Sveti duh Coordinator of this site? Confirm its status | Zagreb | Croatia | Unknown status |
| Heim Pal Orszagos Gyermekgyogyaszati Intezet Coordinator of this site? Confirm its status | Budapest | Hungary | Unknown status |
| Eszak-Pesti Centrumkórház-Honvédkórház Coordinator of this site? Confirm its status | Budapest | Hungary | Unknown status |
| Debreceni Egyetem Coordinator of this site? Confirm its status | Debrecen | Hungary | Unknown status |
| Mohácsi Kórház Coordinator of this site? Confirm its status | Mohács | Hungary | Unknown status |
| Szabolcs Szatmár Bereg Vármegyei Oktatókórház Coordinator of this site? Confirm its status | Nyíregyháza | Hungary | Unknown status |
| Pécsi Tudományegyetem Klinikai Központ Coordinator of this site? Confirm its status | Pécs | Hungary | Unknown status |
| Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico Coordinator of this site? Confirm its status | Milan | Italy | Unknown status |
| Fondazione Policlinico Universitario Agostino Gemelli IRCCS Coordinator of this site? Confirm its status | Roma | Italy | Unknown status |
| Azienda Ospedaliera Universitaria Policlinico Umberto I - Università di Roma La Sapienza Coordinator of this site? Confirm its status | Roma | Italy | Unknown status |
| Kyung Hee University Hospital at Gangdong Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
| Ulsan University Hospital Coordinator of this site? Confirm its status | Ulsan | South Korea | Unknown status |
| University Medical Centre Groningen-UMCG Coordinator of this site? Confirm its status | Groningen | Netherlands | Unknown status |
| Sahlgrenska Universitetssjukhuset Coordinator of this site? Confirm its status | Gothenburg | Sweden | Unknown status |
| King Chulalongkorn Memorial Hospital Coordinator of this site? Confirm its status | Bangkok | Thailand | Unknown status |
| Phramongkutklao Hospital Coordinator of this site? Confirm its status | Bangkok | Thailand | Unknown status |
| Siriraj Hospital Coordinator of this site? Confirm its status | Bangkoknoi Bangkok | Thailand | Unknown status |
| Maharaj Nakorn Chiang Mai Hospital Coordinator of this site? Confirm its status | Chiang Mai | Thailand | Unknown status |
| Tri-Service General Hospital Coordinator of this site? Confirm its status | Taipei | Taiwan | Unknown status |
| Mackay Memorial Hospital-Taipei branch Coordinator of this site? Confirm its status | Taipei | Taiwan | Unknown status |
| Chang Gung Memorial Hospital, Linkou Coordinator of this site? Confirm its status | Taoyuan | Taiwan | Unknown status |
| UF Health Shands Hospital Coordinator of this site? Confirm its status | Gainesville | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.