Clinical and Health-related Outcome of rFVIIIFc Prophylaxis (CLHEAR)

Prof. Dr. Dr. Thomas Hilberg

Status: Unknown

Conditions: Hemophilia A

Study type: Observational

Funder types: Other

Identifiers

NCT04583930

Hae-Ger-2019-251-Hil

Details and patient eligibility

About

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.

Enrollment: 48 estimated patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients suffering from moderate to severe haemophilia A
• Age ≥ 18-years
• Treatment with FVIII prophylaxis
• Submitted written informed consent

Exclusion criteria

Patients suffering from other bleeding diseases

• Patients with inhibitors
• Patients without written informed consent
• Age < 18-year-old
• Any surgeries up to 6 months before the examination date
• Suffering from different rheumatologic diseases like M. Bechterew, Psoriasis or other local or generalized joint infections (Borreliosis, septic arthritis)

Trial design

48 participants in 1 patient group

Patients with Haemophilia A

Description:

* Patients suffering from moderate to severe haemophilia A * Age ≥ 18-years * Treatment with FVIII prophylaxis * Submitted written informed consent