There are 9 phase-3 trials in all: 6 trials that comprise the initial NDA submission in 2Q14 and 3 trials for subsequent use. All trials include the 3-DAA combination of the protease inhibitor, ABT-450 (licensed from ENTA); the NS5A inhibitor, ABT267; and the non-nucleoside polymerase inhibitor, ABT333.
Six phase-3 trials comprising initial NDA submission:
SAPPHIRE-1 (treatment-naïve GT1 w/o cirrhosis; ABT-450/ABT-267/ABT-333/ribavirin for 12w vs. placebo for 12w followed by treatment for 12w as above)—600 patients; primary outcome Sep 2013: http://www.clinicaltrials.gov/ct2/show/NCT01716585
SAPPHIRE-2 (treatment-experienced GT1 w/o cirrhosis; ABT-450/ABT-267/ABT-333/ribavirin for 12w vs. placebo for 12w followed by treatment for 12w as above)—400 patients; primary outcome Sep 2013: http://www.clinicaltrials.gov/ct2/show/NCT01715415
PEARL-2 (treatment-experienced GT1b w/o cirrhosis; ABT-450/ABT-267/ABT-333/ribavirin for 12w vs. ABT-450/ABT-267/ABT-333 (w/o ribavirin) for 12w)—210 patients; primary outcome Mar 2014: http://www.clinicaltrials.gov/ct2/show/NCT01674725
PEARL-3 (treatment-naïve GT1b w/o cirrhosis; ABT-450/ABT-267/ABT-333/ribavirin for 12w vs. ABT-450/ABT-267/ABT-333 (w/o ribavirin) for 12w)—400 patients; primary outcome Dec 2013: http://www.clinicaltrials.gov/ct2/show/NCT01767116
PEARL-4 (treatment-naïve GT1a w/o cirrhosis; ABT-450/ABT-267/ABT-333/ribavirin for 12w vs. ABT-450/ABT-267/ABT-333 (w/o ribavirin) for 12w)—300 patients; primary outcome Dec 2013: http://www.clinicaltrials.gov/ct2/show/NCT01767116
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