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Cheat Sheet for ABBV/ENTA Phase-3 HCV Program

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DewDiligence Member Level  Sunday, 07/28/13 03:50:31 PM
Re: DewDiligence post# 164529
Post # of 239688 
Cheat Sheet for ABBV/ENTA Phase-3 HCV Program

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

TURQUOISE-2 (GT1 with cirrhosis; ABT-450/ABT-267/ABT333/ribavirin for 12w vs. identical regimen for 24w)—380 patients; primary outcome Dec 2013:
http://www.clinicaltrials.gov/ct2/show/NCT01704755


Three phase-3 trials not part of initial NDA submission:

MALACHITE-1 (treatment-naïve GT1; ABT-450/ABT-267/ABT-333/ribavirin for 12w vs. Incivek+peg/riba for 12w)—314 patients; primary outcome Jul 2015:
http://www.clinicaltrials.gov/ct2/show/NCT01854697

MALACHITE-2 (treatment-experienced GT1; ABT-450/ABT-267/ABT-333/ribavirin for 12w vs. Incivek+peg/riba for 12w)—150 patients; primary outcome Jul 2015:
http://www.clinicaltrials.gov/ct2/show/NCT01854528

TURQUOSE-1 (HIV/HCV co-infection).

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