NCT02078427Completed
ADVATE/ ADYNOVI Hemophilia A Outcome Database (AHEAD)
ADVATE/ ADYNOVI Hemophilia A Outcome Database
Source: ClinicalTrials.gov · Last updated 17 Jun 2024
Brief summary (registry, in English)
The purpose of the study is to document the natural history of hemophilia A disease and long-term outcomes in terms of effectiveness, safety and quality of life in participants receiving Antihemophilic Factor (Recombinant) - Plasma/Albumin Free Method (rAHF-PFM) or Antihemophilic Factor (Recombinant) - Pegylated (rAHF-PEG) in routine clinical practice
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 951 (actual)
- First submitted
- 3 Mar 2014
- Start date
- 28 Jun 2011
- Primary completion date
- 16 Jan 2024
- Lead sponsor
- Baxalta now part of Shire
- Diseases
- Haemophilia
- NCT number
- NCT02078427
What you commit to
- Study type: Observational
- Participants enrolled: 951
- From 28 Jun 2011 to the primary completion date, 16 Jan 2024
- 110 sites in 22 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
- Participant has participated in another clinical study involving an investigational product (IP) or device within 30 days prior to study enrollment or is scheduled to participate in another clinical study involving another FVIII concentrate or device during the course of this study
Other illness
- Participant has known hypersensitivity to the active substance or any of the excipients
- Participant has known allergic reaction to mouse or hamster proteins
Who the study is looking for
- Participant has hemophilia A {FVIII lesser than or equal to (\<=)5%}
- Participant is prescribed Antihemophilic Factor (Recombinant) - Plasma/Albumin Free Method (rAHF-PFM) or Antihemophilic Factor (Recombinant) - Pegylated (rAHF-PEG) by the treating physician
- Participant or participant's legally authorized representative provides informed consent
Sex: All · Does not accept healthy volunteers
Sites (110)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Kepler Universitätsklinikum Klinik für Kinder-und Jugendheilkunde Coordinator of this site? Confirm its status | Linz | Austria | Unknown status |
| Landes Frauen und Kinderklinik Linz (LFKK Linz) Coordinator of this site? Confirm its status | Linz | Austria | Unknown status |
| Medizinische Universitaet Wien Coordinator of this site? Confirm its status | Vienna | Austria | Unknown status |
| Royal Prince Alfred Hospital Coordinator of this site? Confirm its status | Camperdown | Australia | Unknown status |
| South Metropolitan Health Service trading as Fiona Stanley Hospital Coordinator of this site? Confirm its status | Murdoch | Australia | Unknown status |
| Cliniques universitaires Saint-Luc Coordinator of this site? Confirm its status | Brussels | Belgium | Unknown status |
| Fundação HEMOPA Coordinator of this site? Confirm its status | Belém | Brazil | Unknown status |
| Hemocentro Da UNICAMP Coordinator of this site? Confirm its status | Campinas | Brazil | Unknown status |
| Hemepar - Pr Coordinator of this site? Confirm its status | Curitiba | Brazil | Unknown status |
| Hemoce - Ce Coordinator of this site? Confirm its status | Fortaleza | Brazil | Unknown status |
| Hemorgs - Rs Coordinator of this site? Confirm its status | Porto Alegre | Brazil | Unknown status |
| Hemocentro Ribeirão Preto - SP Coordinator of this site? Confirm its status | Ribeirão Preto | Brazil | Unknown status |
| Hemorio - Rj Coordinator of this site? Confirm its status | Rio de Janeiro | Brazil | Unknown status |
| Faculdade de Medicina Da Universidade de São Paulo Coordinator of this site? Confirm its status | São Paulo | Brazil | Unknown status |
| Hemocentro do Espírito Santo Coordinator of this site? Confirm its status | Vitória | Brazil | Unknown status |
| Stollery Children's Hospital University of Alberta Coordinator of this site? Confirm its status | Edmonton | Canada | Unknown status |
| The Moncton City Hospital Coordinator of this site? Confirm its status | Moncton | Canada | Unknown status |
| Children'S Hospital Of Eastern Ontario Coordinator of this site? Confirm its status | Ottawa | Canada | Unknown status |
| Royal University Hospital Coordinator of this site? Confirm its status | Saskatoon | Canada | Unknown status |
| Sick Kids Hospital Coordinator of this site? Confirm its status | Toronto | Canada | Unknown status |
| St. Michael's Hospital Coordinator of this site? Confirm its status | Toronto | Canada | Unknown status |
| Universitätsspital Basel Coordinator of this site? Confirm its status | Basel | Switzerland | Unknown status |
| Inselspital Bern Coordinator of this site? Confirm its status | Bern | Switzerland | Unknown status |
| Centre Hospitalier Universitaire Vaudois Coordinator of this site? Confirm its status | Lausanne | Switzerland | Unknown status |
| Luzerner Kantonsspital Coordinator of this site? Confirm its status | Lucerne | Switzerland | Unknown status |
| Kantonsspital St. Gallen Coordinator of this site? Confirm its status | Sankt Gallen | Switzerland | Unknown status |
| FMH Kinder und Jugendmedizin, im Wabern-Zentrum Coordinator of this site? Confirm its status | Wabern | Switzerland | Unknown status |
| Kinderspital Zürich Coordinator of this site? Confirm its status | Zurich | Switzerland | Unknown status |
| Universitätsspital Zürich Coordinator of this site? Confirm its status | Zurich | Switzerland | Unknown status |
| Beijing Children's Hospital Affiliated to Capital University of Medical Sciences Coordinator of this site? Confirm its status | Beijing | China | Unknown status |
| Nanfang Hospital Affiliated to Nanfang Medical University Coordinator of this site? Confirm its status | Guangzhou | China | Unknown status |
| The Blood Center of Shandong Province Coordinator of this site? Confirm its status | Jinan | China | Unknown status |
| Nanjing Drum Tower Hospital The Affiliated Hospital of Nanjing University Medical School Coordinator of this site? Confirm its status | Nanjing | China | Unknown status |
| Shenzhen Children's Hospital Coordinator of this site? Confirm its status | Shenzhen | China | Unknown status |
| Shenzhen Second People's Hospital Coordinator of this site? Confirm its status | Shenzhen | China | Unknown status |
| Institute of Hematology, Blood Disease Hospital, PUMC&CAMS Coordinator of this site? Confirm its status | Tianjin | China | Unknown status |
| Tongji Hospital, Tongji Medical College of Huazhong University of Science & Technology Coordinator of this site? Confirm its status | Wuhan | China | Unknown status |
| The affiliated hospital of xuzhou medical university Coordinator of this site? Confirm its status | Xuzhou | China | Unknown status |
| IPS FUSA SAS Centro Integral de Coagulacion Coordinator of this site? Confirm its status | Atlántico | Colombia | Unknown status |
| Integral Solutions SD SAS Coordinator of this site? Confirm its status | Bogotá | Colombia | Unknown status |
| Fundacion Oftalmologica de Santander - FOSCAL Coordinator of this site? Confirm its status | Floridablanca | Colombia | Unknown status |
| Fakultni nemocnice Brno Coordinator of this site? Confirm its status | Brno | Czechia | Unknown status |
| Fakultni nemocnice Ostrava Coordinator of this site? Confirm its status | Ostrava | Czechia | Unknown status |
| Fakultní nemocnice Ostrava, Oddělení dětské hematologie a hematoonkologie Coordinator of this site? Confirm its status | Ostrava | Czechia | Unknown status |
| Fakultni nemocnice v Motole Coordinator of this site? Confirm its status | Prague | Czechia | Unknown status |
| Rigshospitalet Coordinator of this site? Confirm its status | Copenhagen | Denmark | Unknown status |
| Hospital Teresa Herrera - Materno Infantil Coordinator of this site? Confirm its status | A Coruña | Spain | Unknown status |
| Hospital Hospital Sant Joan de Déu Coordinator of this site? Confirm its status | Barcelona | Spain | Unknown status |
| Hospital Universitari Vall d'Hebron (HUVH) Coordinator of this site? Confirm its status | Barcelona | Spain | Unknown status |
| Hospital Universitario Son Espases Coordinator of this site? Confirm its status | Palma de Mallorca | Spain | Unknown status |
| Hôpital Morvan CHRU de Brest Coordinator of this site? Confirm its status | Brest | France | Unknown status |
| CHU Côte de Nacre - CRTH Coordinator of this site? Confirm its status | Caen | France | Unknown status |
| Centre Hospitalier Générale - CTH Coordinator of this site? Confirm its status | Chambéry | France | Unknown status |
| CTRH - CHU Bocage Coordinator of this site? Confirm its status | Dijon | France | Unknown status |
| Hôpital André Mignot Coordinator of this site? Confirm its status | Le Chesnay | France | Unknown status |
| Hôpital de la Mère et de l'Enfant - CHU de LIMOGES Coordinator of this site? Confirm its status | Limoges | France | Unknown status |
| CHRU Hôtel Dieu - CRTH Coordinator of this site? Confirm its status | Nantes | France | Unknown status |
| Hôpital Cochin Coordinator of this site? Confirm its status | Paris | France | Unknown status |
| CHU de Reims Hôpital Maison Blanche - CRTH Coordinator of this site? Confirm its status | Reims | France | Unknown status |
| Centre Régional de Traitement de l'Hémophilie et des Maladies hémorragiques. CHU de Rennes - Hôpital Pontchaillou Coordinator of this site? Confirm its status | Rennes | France | Unknown status |
| CHRU Charles Nicolle Coordinator of this site? Confirm its status | Rouen | France | Unknown status |
| CIC Coordinator of this site? Confirm its status | Saint-Priest-en-Jarez | France | Unknown status |
| CHRU Purpan CRTH - Pavillon Sénac Coordinator of this site? Confirm its status | Toulouse | France | Unknown status |
| Hampshire Hospitals NHS Foundation Trust, Basingstoke and North Hampshire Hospital Coordinator of this site? Confirm its status | Basingstoke | United Kingdom | Unknown status |
| Cambridge University Hospital NHS Foundation Trust, Addenbrooke's Hospital Coordinator of this site? Confirm its status | Cambridge | United Kingdom | Unknown status |
| East Kent Hospitals University Foundation Trust, Kent & Canterbury Hospital Coordinator of this site? Confirm its status | Canterbury | United Kingdom | Unknown status |
| Great Ormond Street Hospital For Children NHS Trust Coordinator of this site? Confirm its status | London | United Kingdom | Unknown status |
| Aghia Sofia Children's Hospital Coordinator of this site? Confirm its status | Goudi | Greece | Unknown status |
| Laikon General Hospital Coordinator of this site? Confirm its status | Goudi | Greece | Unknown status |
| General Hospital of Thessaloniki "Ippokratio" Coordinator of this site? Confirm its status | Thessaloniki | Greece | Unknown status |
| Heim Pál Gyermekkórház Coordinator of this site? Confirm its status | Budapest | Hungary | Unknown status |
| Debreceni Egyetem Klinikai Kozpont Coordinator of this site? Confirm its status | Debrecen | Hungary | Unknown status |
| Mohács City Hospital Coordinator of this site? Confirm its status | Mohács | Hungary | Unknown status |
| Jósa András County Hospital Coordinator of this site? Confirm its status | Nyíregyháza | Hungary | Unknown status |
| Markusovszky Hospital Coordinator of this site? Confirm its status | Szombathely | Hungary | Unknown status |
| Azienda Ospedaliera Policlinico Consorziale Di Bari Coordinator of this site? Confirm its status | Bari | Italy | Unknown status |
| Policlinico S. Orsola Malpighi Coordinator of this site? Confirm its status | Bologna | Italy | Unknown status |
| Azienda Ospedaliera Universitaria Vittorio Emanuele, Ferrarotto, S. Bambino Coordinator of this site? Confirm its status | Catania | Italy | Unknown status |
| Ospedale Pugliese -Ciaccio Coordinator of this site? Confirm its status | Catanzaro | Italy | Unknown status |
| Az. Osp. Univ. Careggi Coordinator of this site? Confirm its status | Florence | Italy | Unknown status |
| Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico Coordinator of this site? Confirm its status | Milan | Italy | Unknown status |
| Azienda Ospedaliera Universitaria Federico II Coordinator of this site? Confirm its status | Naples | Italy | Unknown status |
| Azienda Ospedaliera di Padova Clinica Medica II Coordinator of this site? Confirm its status | Padova | Italy | Unknown status |
| AOUP P. Giaccone Coordinator of this site? Confirm its status | Palermo | Italy | Unknown status |
| Ospedale Di Macerata Coordinator of this site? Confirm its status | Province of Macerata | Italy | Unknown status |
| Azienda Ospedaliera Bianchi-Melacrino-Morelli Coordinator of this site? Confirm its status | Reggio Calabria | Italy | Unknown status |
| Ospedale Pediatrico Bambino Gesù Coordinator of this site? Confirm its status | Roma | Italy | Unknown status |
| Policlinico Universitario Gemelli Coordinator of this site? Confirm its status | Roma | Italy | Unknown status |
| Universita' Degli Studi di Roma La Sapienza Coordinator of this site? Confirm its status | Roma | Italy | Unknown status |
| Centro Emofilia e Coagulopatie Rare Coordinator of this site? Confirm its status | Scorrano | Italy | Unknown status |
| Ospedale Molinette Coordinator of this site? Confirm its status | Torino | Italy | Unknown status |
| Rikshospitalet Coordinator of this site? Confirm its status | Oslo | Norway | Unknown status |
| Rikshospitalet, Oslo University Hospital Coordinator of this site? Confirm its status | Oslo | Norway | Unknown status |
| Szpital Uniwersytecki nr 1 im. dr Andrzeja Jurasza Coordinator of this site? Confirm its status | Bydgoszcz | Poland | Unknown status |
| Samodzielny Publiczny Szpital Kliniczny nr 1 Coordinator of this site? Confirm its status | Gdansk | Poland | Unknown status |
| Samodzielny Publiczny Dzieciecy Szpital Kliniczny Coordinator of this site? Confirm its status | Warsaw | Poland | Unknown status |
| Uniwersytecki Szpital Kliniczny we Wrocławiu Coordinator of this site? Confirm its status | Wroclaw | Poland | Unknown status |
| Centro Hospitalar e Universitade de Coimbra Coordinator of this site? Confirm its status | Coimbra | Portugal | Unknown status |
| Centro Hospitalar Lisboa Norte Hospital de Sta. Maria Coordinator of this site? Confirm its status | Lisbon | Portugal | Unknown status |
| Hospital do Divino Espirito Santo Coordinator of this site? Confirm its status | Ponta Delgada | Portugal | Unknown status |
| Centro Hospitalar de São João, E.P.E. Coordinator of this site? Confirm its status | Porto | Portugal | Unknown status |
| SBHI Chelyabinsk Regional Children's Clinical Hospital Coordinator of this site? Confirm its status | Chelyabinsk | Russia | Unknown status |
| Federal State Budget Institution "Hematology Research Center" of Ministry of Healthcare of Russian Federation Coordinator of this site? Confirm its status | Moscow | Russia | Unknown status |
| SBHI of the Republic of Kareliya Republican Hospital n.a. V.A. Baranov Coordinator of this site? Confirm its status | Petrozavodsk | Russia | Unknown status |
| State Budget Healthcare Institution of Saint-Petersburg "City polyclinic #37" Coordinator of this site? Confirm its status | Saint Petersburg | Russia | Unknown status |
| Clinics of FSBEI High Education Samara SMU of MoH of Russia Coordinator of this site? Confirm its status | Samara | Russia | Unknown status |
| Sahlgrenska University Hospital Coordinator of this site? Confirm its status | Gothenburg | Sweden | Unknown status |
| Kliniska studier i Sverige - Forum Söder Coordinator of this site? Confirm its status | Malmö | Sweden | Unknown status |
| Karolinska Universitetssjukhuset Solna Coordinator of this site? Confirm its status | Stockholm | Sweden | Unknown status |
| University Medical Centre Ljubljana Coordinator of this site? Confirm its status | Ljubljana | Slovenia | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.