Study title:
Phase 1b and Phase 2a clinical trials with an hIL-10-expressing Lactococcus lactis
EU record number:
B/BE/07/BVW1
EudraCT number:
2008-000967-40
Pharmaceutical study code:
AG011-MDUC-201
Company / Sponsor:
ActoGeniX N.V.
Phase:
II
Treated organism:
Humans
Indication category:
Gastrointestinal disorders
Disease:
Ulcerative colitis
Therapeutic approach:
anti-inflammatory treatment
Genetic modification:
Gene coding for the human interleukin-10 (hIL-10)
Method of transfer of nucleic acid of interest:
Lactococcus lactis strain MG1363
Administered biological material:
Recombinant Lactococcus lactis D (thy A)
Route of administration:
Oral and rectal
Locations in Belgium:
Flanders, Wallonia and Brussels as a consequence of clinical trials conducted with patients from all the country recruited at UZ Gasthuisberg (Leuven), Imelda vzw (Bonheiden), UZ Antwerpen and UZ Gent + AZ Groeninge + UCL St Luc
Nr of subjects:
Maximum 120
Foreseen duration:
3 years
Type of procedure:
Contained use and Deliberate release
Current status:
Authorized
Information for the public
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Public information presented according to the provisions of Directive 2001/18/EC
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B/BE/07/BVW1 - Summary Notification Information Format (SNIF)Information related to the decision procedure
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18 January 2008: The Biosafety Advisory Council issues a positive advice (with conditions) for this trial.
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04 February 2008: The Federal Ministers give a final decision (positive) for this trial.