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08/26/10 2:58 PM

#102636 RE: DewDiligence #102626

Did ZGEN recruit all new patients for the phase-2b portion of the trial?



Don't know if the 2a patients with dosing that was carried forward into 2b count as 2b patients. But the effect would be small since the 2b trial has only 3 ifn-l arms and 2a had only 11 patients per arm - i.e. Zymo enrolled at least 530-540 patients in the 2-3/4 months.

If yes, why are the phase-2a and phase-2b portions of the trial not considered two distinct trials?



2a stopped enrolling in Feb (2b didn't start enrolling until Jun). They added 25 (of the 28 you noted) trial sites AFTER the ph 2a (according to clinical trials.org). Different dosings - and probably different protocol for reducing dosing when liver enzymes exceeded.