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B-GT/24: Regulatory and clinical data
(Authors: M. Sneyers and M. Goossens - Last revised:
June 25, 2010
)
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 107 pfu (plaque forming units) of RO5217790 in patients with high grade cervical intraepithelial neoplasia grade 2 or 3 associated with High Risk HPV infection |
Company or sponsor |
Roche |
Pharmaceutical study code |
NV25025 |
| EudraCT number | 2008-006946-24 |
Phase |
phase II |
Unicenter/multicenter study |
multicenter |
| Clinical data | see table 2 |
Installations |
UZ Leuven, UZ Brussel, Regionaaal Ziekenhuis Heilg Hart - Tienen, UZ Antwerpen, Ziekenhuis netwerk Antwerpen, UZ Gent |
Authorisation procedure 1 |
contained use, subsequent use (see relevant regulation) |
Application numbers |
SBB/219/2009/1353 - SBB/219/2009/1355 - SBB/219/2009/1363 - SBB/219/2009/1388 - SBB/219/2009/1408 - SBB/219/2009/1411 - SBB/219/2010/0224 |
User(s) |
Dr. Willy Poppe (UZ Leuven) Dr. Philippe de Sutter (UZ Brussel) Dr. Gilbert Donders (Regionaaal Ziekenhuis Heilg Hart - Tienen) Dr. Wiebren Tjalma (UZ Antwerpen) Dr. Frans Wesling (Ziekenhuis netwerk Antwerpen) Dr. Steven Wyers (UZ Gent) Dr. Philippe Simon (ULB Erasme, Bruxelles) |
Receipt date |
|
| Authorisation procedure 2 | deliberate release for research and development purposes (see regulation in French - in Dutch) |
| Application number | B/BE/09/BVW1 |
| 09/09/2009 | |
Authorisation date |
17/12/2009 |
Status |
trial running |
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