Trials / Completed
CompletedNCT04675541
Register of Patients With haEmophilia A tReated With Afstyla®
Observational Register of Patients With haEmophilia A tReated With Afstyla®
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 62 (actual)
- Sponsor
- CSL Behring · Industry
- Sex
- All
- Age
- —
- Healthy volunteers
- Not accepted
Summary
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
Detailed description
Haemophilia A is a congenital coagulation disorder caused by a deficiency or abnormality of coagulation factor VIII (FVIII). 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
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | Afstyla® | Solution for injection |
Timeline
- Start date
- 2018-09-24
- Primary completion
- 2024-12-31
- Completion
- 2024-12-31
- First posted
- 2020-12-19
- Last updated
- 2025-01-08
Locations
17 sites across 1 country: France
Source: ClinicalTrials.gov record NCT04675541. Inclusion in this directory is not an endorsement.