Biotech Values

[DewDiligence]

ABBV/ENTA’s Global Phase-3 Program for ABT-493/ABT-530

[Updated for start of EXPEDITION-4 study.]


There are six phase-3 trials with a total of 1,600 patients and 250 clinical-trial sites in 27 countries; all of these trials are expected to report data in 2016 or Jan 2017.


ENDURANCE-1—TN non-cirrhotic GT1; 600 patients; 8- and 12-week arms; expected completion Jan 2017:
https://www.clinicaltrials.gov/ct2/show/NCT02604017

ENDURANCE-2—TN/TE non-cirrhotic GT2; 321 patients; 12-week arms (delayed-start control arm for safety comparison); expected completion Dec 2016:
https://www.clinicaltrials.gov/ct2/show/NCT02640482

ENDURANCE-3—TN non-cirrhotic GT3; 345 patients; 12-week arms (ABT-493/ABT-530 head-to-head vs Sovaldi/Daklinza); expected completion Dec 2016:
https://www.clinicaltrials.gov/ct2/show/NCT02640157

ENDURANCE-4—TN/TE non-cirrhotic GT4/GT5/GT6; 130 patients; single 12-week arm; expected completion Jun 2016:
https://www.clinicaltrials.gov/ct2/show/NCT02636595

EXPEDITION-1—TN/TE cirrhotic patients (Child-Pugh A) of all genotypes except GT3; 175 patients; single 12-week arm; expected completion Sep 2016:
https://www.clinicaltrials.gov/ct2/show/NCT02642432

EXPEDITION-4—TN/TE renal-impairment patients (including cirrhotics) of any genotype; 100 patients; single 12-week arm; expected completion Oct 2016:
https://www.clinicaltrials.gov/ct2/show/NCT02651194

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TN=treatment-naïve
TE=treatment-experienced