Register of Patients With haEmophilia A tReated With Afstyla®
NCT ID: NCT04675541
Last Updated: 2025-01-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
62 participants
OBSERVATIONAL
2018-09-24
2024-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Extended Half-Life (EHL) Clotting Factor for Improving the Musculoskeletal Health of Patients With Hemophilia
NCT03914209
Global Haemostatic Methods Following Administration of Bypassing Agents to Patients With Haemophilia With Inhibitors
NCT02453542
A Non-interventional Retrospective Study of the Current Treatment Practice in European Haemophilia Care
NCT02049099
Efficacy and Safety Study of Human-cl rhFVIII in PTPs With Severe Hemophilia A
NCT01125813
Long-term Study Evaluating Joint Health in People With Haemophilia A Receiving Real-world Prophylactic Treatment With Efanesoctocog Alfa
NCT06940830
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
The severity of the haemophilia depends on the magnitude of the FVIII deficiency and the clinical features depend on the site of the bleed.
The therapeutic management of this disease involves administering the deficient factor, FVIII to the patient. Depending on the severity of the disease and patient background, the management regimens are different (long term prophylactic treatment to prevent non surgical bleeds, prophylactic short term treatment to prevent surgical bleeds or treatment of acute bleeds on demand).
Several recombinant or plasma derived treatments are currently available. The CSL Behring Company has designed a new recombinant single chain B1FVIII, rFVIII (Afstyla®). This has increased affinity for VWF, resulting in improved stability and an improvement in its pharmacokinetic indices. OPERA is a non-interventional, prospective and national study which aim is to record real life data in haemophilia A French patients treated with Afstyla® in order to confirm the efficacy and safety of this proprietary product established in clinical development studies.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
COHORT
PROSPECTIVE
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Afstyla®
Solution for injection
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
Exclusion Criteria
* Existence of a contraindication to the use of Afstyla® treatment (known hypersensitivity to FVIII or hamster proteins);
* Simultaneous participation in an interventional clinical study.
* Presence of an inhibitor and/or ongoing immune tolerance.
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
CSL Behring
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Study Director
Role: STUDY_DIRECTOR
CSL Behring SA
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
CHU Brest
Brest, , France
CHU Caen
Caen, , France
CHU Chambéry
Chambéry, , France
CHU Clermont-Ferrand
Clermont-Ferrand, , France
Hôpital Simone Veil
Eaubonne, , France
Hôpital Mignot
Le Chesnay, , France
CRC-MHC Hôpital Kremlin Bicêtre
Le Kremlin-Bicêtre, , France
CHRU Lille
Lille, , France
CHU Limoges
Limoges, , France
CHU Montpellier
Montpellier, , France
CHU Nantes
Nantes, , France
Hôpital Necker
Paris, , France
CHU Rennes
Rennes, , France
CHU Rouen
Rouen, , France
CHU Saint-Etienne
Saint-Etienne, , France
Hôpital Hautepierre
Strasbourg, , France
CHRU de Tours
Tours, , France
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2017-A03517-46
Identifier Type: OTHER
Identifier Source: secondary_id
OPERA study
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.