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SURVEYOR-I: Glecaprevir and Pibrentasvir in Chronic HCV
NCT02243280Phase 2
Key facts
- Status
- Completed
- Start
- Aug 2014
- Primary completion
- Feb 2016
- Sponsor
- AbbVie Inc.
- Modality
- Reversible Covalent Inhibitors, Allosteric Modulators, Orthosteric Ligands
- Conditions
- hepatitis C (HCV)
01
Overview
Phase 2, randomised, open-label trial of glecaprevir and pibrentasvir in hepatitis C (HCV) (5 arms), sponsored by AbbVie Inc. Primary endpoint: Sustained Virologic Response 12 Weeks Post-treatment. Started Aug 2014; status: completed.
02
Design
5 arms- Study design
- RandomizedOpen-label
Arm A
ABT-493 200mg + ABT-530 120mg for 12 weeks (GT1 non-cirrhotic)
Arm B
ABT-493 200mg + ABT-530 40mg for 12 weeks (GT1 non-cirrhotic)
Arm F
ABT-493 200mg + ABT-530 120mg for 12 weeks (GT1 cirrhotic)
Arm I
ABT-493 300mg + ABT-530 120mg for 12 weeks (GT4-6 non-cirrhotic)
Arm K
ABT-493 300mg + ABT-530 120mg for 8 weeks (GT1 non-cirrhotic)
03
Who it enrols
Adults with chronic HCV GT1, 4, 5, or 6 infection, treatment-naive or PR-experienced. Cirrhosis allowed for GT1 (compensated).
04
Endpoints
Primary
Sustained Virologic Response 12 Weeks Post-treatment
Secondary
Sustained Virologic Response 4 Weeks Post-treatment
On-treatment Virologic Failure
Post-treatment Relapse
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