NCT04675541Completed
Register of Patients With haEmophilia A tReated With Afstyla®
Observational Register of Patients With haEmophilia A tReated With Afstyla®
Source: ClinicalTrials.gov · Last updated 8 Jan 2025
Brief summary (registry, in English)
Record real life data of patients with Hemophilia A and treated with Afstyla® to assess the effectiveness and the safety of the treatment used as prophylaxis, prevention of bleeding (e.g. surgery) or on-demand treatment during 3 years after patient inclusion
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 62 (actual)
- First submitted
- 1 Dec 2020
- Start date
- 24 Sept 2018
- Primary completion date
- 31 Dec 2024
- Lead sponsor
- CSL Behring
- Diseases
- Haemophilia
- NCT number
- NCT04675541
What you commit to
- Study type: Observational
- Participants enrolled: 62
- From 24 Sept 2018 to the primary completion date, 31 Dec 2024
- 17 sites in 1 country
- 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
- Presence of an inhibitor and/or ongoing immune tolerance.
Other illness
- Existence of a contraindication to the use of Afstyla® treatment (known hypersensitivity to FVIII or hamster proteins);
Other
- Refusal of the patient or the patient's legal representative to take part in the study;
- Simultaneous participation in an interventional clinical study.
Who the study is looking for
- Have given their agreement to take part in the observational registry after being informed in writing of the purposes of the study and after their data have been recorded (parent's agreement for minor patients);
- Be suffering from haemophilia A and being treated or having been treated with Afstyla® long term prophylactically, on demand or preventatively for a surgical procedure;
- Absence of inhibitor and/or treatment for immune tolerance at the time of inclusion
Sex: All · Does not accept healthy volunteers
Sites (17)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Chu Brest Coordinator of this site? Confirm its status | Brest | France | Unknown status |
| CHU Caen Coordinator of this site? Confirm its status | Caen | France | Unknown status |
| CHU Chambéry Coordinator of this site? Confirm its status | Chambéry | France | Unknown status |
| CHU Clermont-Ferrand Coordinator of this site? Confirm its status | Clermont-Ferrand | France | Unknown status |
| Hôpital Simone Veil Coordinator of this site? Confirm its status | Eaubonne | France | Unknown status |
| Hôpital Mignot Coordinator of this site? Confirm its status | Le Chesnay | France | Unknown status |
| CRC-MHC Hôpital Kremlin Bicêtre Coordinator of this site? Confirm its status | Le Kremlin-Bicêtre | France | Unknown status |
| CHRU Lille Coordinator of this site? Confirm its status | Lille | France | Unknown status |
| CHU Limoges Coordinator of this site? Confirm its status | Limoges | France | Unknown status |
| CHU Montpellier Coordinator of this site? Confirm its status | Montpellier | France | Unknown status |
| CHU Nantes Coordinator of this site? Confirm its status | Nantes | France | Unknown status |
| Hôpital Necker Coordinator of this site? Confirm its status | Paris | France | Unknown status |
| CHU Rennes Coordinator of this site? Confirm its status | Rennes | France | Unknown status |
| CHU Rouen Coordinator of this site? Confirm its status | Rouen | France | Unknown status |
| CHU Saint-Etienne Coordinator of this site? Confirm its status | Saint-Etienne | France | Unknown status |
| Hopital Hautepierre Coordinator of this site? Confirm its status | Strasbourg | France | Unknown status |
| CHRU de Tours Coordinator of this site? Confirm its status | Tours | France | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.