B/BE/12/BVW2 - Public information sheet (written by the notifier)Public information presented according to the provisions of Directive 2001/18/EC
Long title
A Phase 2b, Double-Blind, Placebo-Controlled, Multinational, Multicenter, Randomized Study Evaluating the Safety and Efficacy of Intracoronary Administration of MYDICAR® (AAV1/SERCA2a) in Subjects with Heart Failure (CUPID Phase 2b Trial)
EU record number
B/BE/12/BVW2
EudraCT number
2012-001700-37
Company / Sponsor
Celladon
Phase
IIb
Treated organism
Humans
Indication category
Cardiovascular therapy
Disease
Heart failure
Therapeutic approach
Gene therapy
Genetic modification
Human SERCA2a:CA++ pump involved in the regulation of heart contraction/relaxation cycle
Method of transfer of nucleic acid of interest
Adeno-associated virus serotype 1
Administered biological material
Recombinant AAV1
Route of administration
intracoronary
Locations in Belgium
Aalst, Brussels, Leuven
Nr of subjects
200 worldwide, 15 in Belgium
Foreseen duration
2 years
Type of procedure
Contained use and Deliberate release
Current status
Authorized
Pharmaceutical study code
CELL-004