The FPS Public Health and FAMHP would like to invite you to take part in the public consultation on a clinical trial testing the genetically modified drug PF-07055480 for the treatment of haemophilia A. The public consultation will run from 17 November 2020 to 17 December 2020.
For each clinical trial application related to the use of genetically modified organisms, the authority organises a 30-day public consultation (in accordance with the Royal Decree of 21 February 2005). This gives you the opportunity, as a citizen, to share your opinion on the clinical trial application for the genetically modified drug PF-07055480 for the treatment of haemophilia A.
This clinical trial will be conducted with adult male patients with moderately severe to severe haemophilia A (FVIII:C≤1 %) for a study duration of approximately five years for each participant. The study treatment, a single infusion of PF-07055480 (a gene transfer agent), will be administered on day 1 at a dose of 3x1013 vg/kg of body weight. A minimum of 50 patients will be dosed with PF-07055480 worldwide.
The primary objective of the study is to evaluate the effectiveness of a single infusion of PF-07055480 to participants ≥ 18 and < 65 years of age with moderately severe to severe haemophilia A (FVIII:C≤1 %).
The clinical trial will take place at the Cliniques Universitaires Saint-Luc, Brussels.
How can I share my opinion?
The public consultation runs until 17 December 2020 inclusive. You can now access the various data in the application file, as well as an online form to send your comments or ask your questions about this file.
General information on public consultations on GMOs.