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Clinical and Health-related Outcome of rFVIIIFc Prophylaxis

NCT04583930 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 48

Last updated 2021-05-11

No results posted yet for this study

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

Sponsors & Collaborators

  • Prof. Dr. Dr. Thomas Hilberg

    lead OTHER

Principal Investigators

  • Thomas Hilberg, Prof. · Head of Department

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-02-01
Primary Completion
2023-03-31
Completion
2023-04-20

Countries

  • Germany

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04583930 on ClinicalTrials.gov