A randomized, double blind, placebo controlled, parallel group, multicenter study of the safety and response rate of 3 subcutaneously administered doses of 5 x 10^7 pfu RO5217790 in patients with high grade cervical intraepithelial neoplasia grade 2

×

Message d'erreur

  • Notice : Trying to access array offset on value of type null dans bootstrap_pager() (ligne 53 dans /var/www/biosafety.be/sites/all/themes/bootstrap/templates/system/pager.func.php).
  • Notice : Trying to access array offset on value of type null dans bootstrap_pager() (ligne 95 dans /var/www/biosafety.be/sites/all/themes/bootstrap/templates/system/pager.func.php).
Study title: 
A randomized, double blind, placebo controlled, parallel group, multicenter study of the safety and response rate of 3 subcutaneously administered doses of 5 x 10^7 pfu RO5217790 in patients with high grade cervical intraepithelial neoplasia grade 2
Long title: 
A randomized, double blind, placebo controlled, parallel group, multicenter study of the safety and response rate of 3 subcutaneously administered doses of 5 x 10^7 pfu (plaque forming units) of RO5217790 in patients with high grade cervical intraepithelial neoplasia grade 2 or 3 associated with High Risk HPV infection
EU record number: 
B/BE/09/BVW1
EudraCT number: 
2008-006946-24
Pharmaceutical study code: 
NV25025
Company / Sponsor: 
N.V. Roche S.A.
Phase: 
II
Treated organism: 
Humans
Indication category: 
Cancer therapy
Disease: 
cervical neoplasia
Therapeutic approach: 
Immunotherapy
Genetic modification: 
E6 and E7 genes of the HPV16 virus and gene of the human Interleukin-2 (hIL2)
Method of transfer of nucleic acid of interest: 
Modified Vaccinia virus Ankara (MVA)
Administered biological material: 
Recombinant Attenuated Vaccinia virus
Route of administration: 
subcutaneous
Locations in Belgium: 
Flanders, Wallonia and Brussels as a consequence of the clinical trial conducted with patients recruited at UZ Brussel, UZ Gent, UZ Gasthuisberg (Leuven), UZ Antwerpen, AZ Middelheim (Antwerpen), AZ Heilig-Hart (Tienen), ULB Erasme (Brussels)
Nr of subjects: 
about 100 patients in Europe, 200 patients worldwide
Foreseen duration: 
13 months
Type of procedure: 
Contained use and Deliberate release
Current status: 
Authorized
Notes: 
trial completed - 17 patients included in Belgium

Information related to the decision procedure