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B-GT/20: Regulatory and clinical data
(Authors: M. Sneyers and M. Goossens - Last revised: August 6, 2008 )

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Title

A multicenter, randomized, double-blind, placebo-controlled study evaluating the efficacy of Biobypass (ADGVVEGF121.10NH) delivered by NOGATM-guided/MYOSTARTM catheter in "no option" patients with class II-IV stable angina

Company or sponsor

GenVec, Inc.

Pharmaceutical study code

GV-002.001 (NOVA trial)
EudraCT number 2004-001250-91

Phase

phase II

Unicenter/multicenter study

multicenter
Clinical data see table 2

Installation

AZ Middelheim, Antwerpen

Authorisation procedure

contained use, first use (see relevant regulation)

Application number

SBB 219 2005/0657

User(s)

Dr. G. Van Langenhove

Receipt date

05-07-2005

Biosafety Council meeting date

-

Authorisation date

-

Status

study withdrawn by notifier

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