Trials / Unknown
UnknownNCT04583930
Clinical and Health-related Outcome of rFVIIIFc Prophylaxis
Clinical and Health-related Outcome of rFVIIIFc Prophylaxis in Patients With Haemophilia A
- Status
- Unknown
- Phase
- —
- Study type
- Observational
- Enrollment
- 48 (estimated)
- Sponsor
- Prof. Dr. Dr. Thomas Hilberg · Academic / Other
- Sex
- Male
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
Current standard therapy for patients with haemophilia (PwH) in the prevention of bleeding episodes is a prophylactic intravenous treatment with recombinant coagulation factor (F) VIII (Haemophilia A) or rather FIX (Haemophilia B) two to three times weekly. With the development of recombinant factor VIII Fc fusion protein (rFVIIIFc) the conventional routine prophylaxis regime is complemented by an extended half-life (EHL) factor replacement prophylaxis with the potential of improved bleed prevention and reduced injection frequency at similar factor consumption. Aim of this longitudinal multicentre study is to evaluate the influence of an EHL factor replacement regime with rFVIIIFc on haemophilic specific parameters (annual bleeding rate, bleeding localisation), joint status, pain, functional parameters, treatment adherence and health-related quality of life in PwH A.
Conditions
Timeline
- Start date
- 2021-02-01
- Primary completion
- 2023-03-31
- Completion
- 2023-04-20
- First posted
- 2020-10-12
- Last updated
- 2021-05-11
Locations
2 sites across 1 country: Germany
Source: ClinicalTrials.gov record NCT04583930. Inclusion in this directory is not an endorsement.