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B-GT/19: Regulatory and clinical data
(Authors: M. Sneyers and M. Goossens - Last revised:
June 18, 2008
)
Title |
A Controlled, Randomised, Parallel Group, Multicentre Study of the Efficacy and Safety of Herpes Simplex Virus-Thymidine Kinase Gene Therapy (CereproTM), with Subsequent Ganciclovir, for the Treatment of Patients with Operable High-Grade Glioma |
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Company or sponsor |
Ark Therapeutics Ltd |
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Pharmaceutical study code |
Protocol 904 |
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| EudraCT number | 2004-000464-28 | ||
Phase |
III |
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Unicenter/multicenter study |
multicenter |
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| Clinical data | see table 2 | ||
Installation |
Academisch Ziekenhuis - Vrije Universiteit Brussel |
Cliniques Universitaires de Bruxelles - Hôpital Erasme |
Centre Hospitalier Universitaire de Liège |
Authorisation procedure |
contained use, new operation (see relevant regulation) |
contained use, new operation (see relevant regulation) |
contained use, first use (see relevant regulation) |
Application number |
SBB 219 2005/0073 |
SBB 219 2005/0081 |
SBB 219 2005/0250 |
User(s) |
Dr. C. Chaskis |
Dr. O. De Witte, Prof. T. Velu |
Dr. Pierre Robe |
Receipt date |
01/02/2005 | 03/02/2005 | 11/03/2005 |
Biosafety Council meeting date |
- |
- | - |
Authorisation date |
26/04/2005 |
11/05/2005 | 27/10/05 |
Status |
trial completed |
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