Dynamics of the Anti-factor VIII Antibody Signature During Treatment With Emicizumab
Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Observational
SUMMARY
The goal of this observational study is to learn about the changes of antibodies and inhibitors against the coagulation factor VIII in patients with severe hemophilia A receiving emicizumab therapy. No additional visits or procedures are planned. Patients in this study will continue to receive their routine care and analysis will be done from left over samples from routine visits.
Eligibility
Participation Requirements
Sex: All
Healthy Volunteers: f
View:
• Severe congenital hemophilia A (CHA)
• Treatment with emicizumab irrespective of any other treatment
• Informed consent
Locations
Other Locations
Germany
University Hospital Frankfurt, Goethe University
RECRUITING
Frankfurt Am Main
Contact Information
Primary
Stephan Schultze-Strasser, Dr.
stephan.schultze-strasser@kgu.de
+496963016998
Backup
Christoph Koenigs, PD Dr. Dr
christoph.koenigs@kgu.de
+4969630183030
Time Frame
Start Date: 2023-04-26
Estimated Completion Date: 2029-12
Participants
Target number of participants: 100
Treatments
Inhibitor negative, FVIII on demand or regularly
Patients with severe hemophilia A receiving emicizumab therapy which are negative for factor VIII Inhibitor (including patients post ITI) and are receiving factor VIII therapy either on demand or regularly,
Inhibitor positive, FVIII therapy regularly (ITI)
Patients with severe hemophilia A receiving emicizumab therapy which are positive for factor VIII Inhibitor and are receiving regularly factor VIII therapy (ITI)
Inhibitor positive, no FVIII therapy
Patients with severe hemophilia A receiving emicizumab therapy which are positive for factor VIII Inhibitor and are receiving no factor VIII therapy
Related Therapeutic Areas
Sponsors
Leads: Christoph Königs
Collaborators: Chugai Pharma Germany GmbH, Roche Pharma AG