An Open-Label, Multicenter Study to Evaluate Long-Term Outcomes With ABT-450/Ritonavir/ ABT-267 (ABT-450/r/ABT-267) and ABT-333 With or Without Ribavirin (RBV) in Adults With Genotype 1 Chronic Hepatitis C Virus (HCV) Infection (TOPAZ-I)
An Open-Label, Multicenter Study to Evaluate Long-Term Outcomes With ABT-450/Ritonavir/ ABT-267 (ABT-450/r/ABT-267) and ABT-333 With or Without Ribavirin (RBV) in Adults With Genotype 1 Chronic Hepatitis C Virus (HCV) Infection (TOPAZ-I)
The purpose of this study was to evaluate the effect of treatment with ABT-450 co-formulated with ritonavir and ABT-267 (ABT-450/r/ABT-267) and ABT-333; 3-DAA regimen, with or without ribavirin (RBV) in adults with chronic hepatitis C virus genotype 1 (HCV GT1) infection.
This study (TOPAZ-I; M14-423), was a Phase 3b, open-label, multicenter study conducted outside of the United States which, together with its companion study TOPAZ-II (M14-222; NCT 02167945) conducted in the United States, was designed with the primary objective of assessing the effect of treatment response on long-term clinical outcomes in adults with chronic HCV GT1 infection with or without compensated cirrhosis, who were either treatment-naïve or interferon/ribavirin (IFN/RBV) treatment- experienced. In both studies, participants were treated with the 3-DAA regimen with or without RBV. This study consisted of a screening period of up to 42 days, a treatment period of either 12 weeks for HCV GT1a-infected subjects without cirrhosis and for HCV GT1b-infected subjects without cirrhosis or with compensated cirrhosis or 24 weeks for GT1a-infected participants with compensated cirrhosis, and a 260-week post-treatment period.
Inclusion Criteria:
Exclusion Criteria:
Fitzroy Melbourne, Victoria 3065, Australia
Brussels, Brussels Capital 1070, Belgium
Winnipeg, Manitoba R3E 3P4, Canada
Montreal, Quebec H4A 3J1, Canada
Tübingen, Baden-Wurttemberg 72076, Germany
Düsseldorf, North Rhine-Westphalia 40237, Germany
Herne, North Rhine-Westphalia 44623, Germany
Berlin, 13353, Germany
Elm Park, Dublin D04 T6F4, Ireland
Cona, Ferrara 44124, Italy
San Giovanni Rotondo, Foggia 71013, Italy
Bergamo, 24127, Italy
Salerno, 84131, Italy
Udine, 33100, Italy
Distrito Federal, 14000, Mexico
Lorenskog, Akershus 1478, Norway
Bydgoszcz, Kuyavian-Pomeranian Voivodeship 85-030, Poland
Lublin, Lublin Voivodeship 20-081, Poland
Bialystok, Podlaskie Voivodeship 15-276, Poland
Lodz, Łódź Voivodeship 91-347, Poland
Lisbon, 1169-050, Portugal
Lisbon, 1649-035, Portugal
Porto, 4099-001, Portugal
Sector 2, Bucharest 021105, Romania
Timișoara, Timiș County 300310, Romania
Kazan', Tatarstan, Respublika 420140, Russia
Krasnoyarsk, 660049, Russia
Moscow, 129090, Russia
Poole, Dorset BH15 2JB, United Kingdom
Southampton, Hampshire SO16 6YD, United Kingdom
London, London, City of NW3 2QG, United Kingdom
Nottingham, Nottinghamshire NG5 1PB, United Kingdom