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B-GT/2: Regulatory and clinical data
(Authors: M. Sneyers and M. Goossens - Last revised:
February 28, 2006
)
Title |
Prospective, open-label, parallel-group, randomized, multicenter trial comparing the efficacy of surgery, radiation, and injection of murine cells producing herpes simplex thymidine kinase vector followed by intravenous ganciclovir against the efficacy of surgery and radiation in the treatment of newly diagnosed, previously untreated gliogblastoma |
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Company or sponsor |
Genetic therapy, Inc., Sandoz Pharma, Ltd |
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Pharmaceutical study code |
GTI-0115 |
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Phase |
III |
|
Unicenter/multicenter study |
multicenter |
|
| Clinical data | see table 2 | |
Installation |
Hôpital Erasme, Brussels |
Universitair Ziekenhuis Antwerpen |
Authorisation procedure |
contained use, modification of operation (see relevant regulation) |
contained use, first use (see relevant regulation) |
Application number |
SBB 219 96/0582 |
DBB 219 96/0688 |
User(s) |
Prof. Dr J. Brotchi and Prof. Dr T. Velu |
Dr E. Van de Kelft |
Receipt date |
24/10/1996 |
09/12/1996 |
Biosafety Council meeting date |
- |
- |
Authorisation date |
05/02/1997 |
05/03/1997 |
Status |
trial completed |
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