A Study to Evaluate Long-term Outcomes Following Treatment 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.

Study Overview

• Status: Completed
• Conditions: Chronic Hepatitis C Virus (HCV) Infection Genotype 1
• Intervention / Treatment: Drug: ABT-450/r/ABT-267; Drug: ABT-333; Drug: Ribavirin (RBV)

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 1596
• Phase: Phase 3

Contacts and Locations

Study Locations

• Algeria
  • Algiers, Algeria, 16000
    • CHU Bab El Oued /ID# 145420
  • Algiers, Algeria, 16000
    • CHU Bologhine Hospital /ID# 145421
  • Algiers, Algeria, 16000
    • CHU Mustapha Bacha /ID# 132130
• Australia
  • New South Wales
    • Darlinghurst, New South Wales, Australia, 2010
      • St Vincent's Hospital Sydney /ID# 131001
    • Kingswood, New South Wales, Australia, 2747
      • Nepean Hospital /ID# 130999
    • Westmead, New South Wales, Australia, 2145
      • Westmead Hospital /ID# 130997
  • Queensland
    • Greenslopes, Queensland, Australia, 4120
      • Greenslopes Private Hospital /ID# 131003
    • Herston, Queensland, Australia, 4029
      • Royal Brisbane and Women's Hospital /ID# 131004
  • South Australia
    • Adelaide, South Australia, Australia, 5000
      • Royal Adelaide Hospital /ID# 131002
  • Victoria
    • Fitzroy Melbourne, Victoria, Australia, 3065
      • St Vincent's Hospital Melbourne /ID# 131000
    • Parkville, Victoria, Australia, 3050
      • The Royal Melbourne Hospital /ID# 130998
• Austria
  • Oberoesterreich
    • Linz, Oberoesterreich, Austria, 4010
      • Ordensklinikum Linz GmbH Elisabethinen /ID# 131017
  • Steiermark
    • Graz, Steiermark, Austria, 8036
      • Medizinische Universitaet Graz /ID# 131018
  • Wien
    • Vienna, Wien, Austria, 1090
      • Medizinische Universitaet Wien /ID# 131015
• Belgium
  • Bruxelles-Capitale
    • Brussels, Bruxelles-Capitale, Belgium, 1070
      • Cliniques Universitaires de Bruxelles Hopital Erasme /ID# 131020
    • Woluwe-Saint-Lambert, Bruxelles-Capitale, Belgium, 1200
      • UCL Saint-Luc /ID# 131019
  • Vlaams-Brabant
    • Leuven, Vlaams-Brabant, Belgium, 3000
      • Universitair Ziekenhuis Leuven /ID# 131021
• Bulgaria
  • Sofia, Bulgaria, 1407
    • Tokuda Hospital Sofia /ID# 131022
  • Sofia, Bulgaria, 1527
    • Univ Hosp for Active Treat /ID# 131023
  • Sofia, Bulgaria, 1612
    • Diagnostic Consultative Center /ID# 131027
  • Sofia, Bulgaria, 1431
    • UMHAT Sveti Ivan Rilski /ID# 131026
  • Varna, Bulgaria, 9010
    • UMHAT Sveta Marina /ID# 131025
• Canada
  • Alberta
    • Calgary, Alberta, Canada, T2N 4Z6
      • University of Calgary /ID# 134370
    • Edmonton, Alberta, Canada, T5H 4B9
      • GI Research & Associates /ID# 132169
  • British Columbia
    • Vancouver, British Columbia, Canada, V6Z 2C7
      • Vancouver Infectious Diseases Centre /ID# 134369
    • Vancouver, British Columbia, Canada, V6Z 2K5
      • GIRI Gastrointestinal Research Institute /ID# 132171
    • Vancouver, British Columbia, Canada, V5Z 1H3
      • LAIR Centre /ID# 130970
  • Manitoba
    • Winnipeg, Manitoba, Canada, R3E 3P4
      • University of Manitoba / Health Scuience Centre / John Buhler Research Centre /ID# 130969
  • New Brunswick
    • Saint John, New Brunswick, Canada, E2L 4L2
      • Saint John Regional Hospital /ID# 131210
  • Ontario
    • Ottawa, Ontario, Canada, K1H 8L6
      • Ottawa Hospital Research Institute /ID# 132170
    • Toronto, Ontario, Canada, M5G 2C4
      • Toronto General Hospital /ID# 132134
    • Toronto, Ontario, Canada, M6H 3M1
      • Toronto Liver Centre /ID# 132168
    • Vaughan, Ontario, Canada, L4L 4Y7
      • Toronto Digestive Disease Asso /ID# 130968
  • Quebec
    • Montreal, Quebec, Canada, H2L 4P9
      • Clinique Medicale L'Actuel /ID# 132167
    • Montreal, Quebec, Canada, H3T 1E2
      • Jewish General Hospital /ID# 132165
    • Montreal, Quebec, Canada, H4A 3J1
      • Royal Victoria Hospital / McGill University Health Centre /ID# 132166
    • Québec, Quebec, Canada, G1V 4G2
      • CHU de Quebec-Université Laval hôpital CHUL /ID# 132132
• Denmark
  • Aarhus, Denmark, 8200
    • Aarhus Univ Hospital, Skejby /ID# 131030
  • Hovedstaden
    • Hvidovre, Hovedstaden, Denmark, 2650
      • Kobenhavns Universitet - Hvidovre Hospital (HH) /ID# 131031
  • Syddanmark
    • Odense C, Syddanmark, Denmark, 5000
      • Odense University Hospital /ID# 131029
• Finland
  • Turku, Finland, 20520
    • Turku University Hospital /ID# 131032
  • Uusimaa
    • Helsinki, Uusimaa, Finland, 00290
      • Helsinki University Hospital /ID# 131034
• France
  • Bondy, France, 93140
    • Hopital Jean Verdier /ID# 135877
  • La Tronche, France, 38700
    • CHU Grenoble - Hopital Michallon /ID# 131041
  • Lyon, France, 69004
    • HCL - Hopital de la Croix-Rousse /ID# 131042
  • Nice, France, 06202
    • Duplicate_Hopital lArchet 2 /ID# 131040
  • Rennes, France, 35033
    • CHRU Pontchaillou /ID# 132173
  • Strasbourg cedex, France, 67091
    • CHU Strasbourg - Hopital Civil /ID# 132174
  • Toulouse, France, 31059
    • Hopital Universitaire Purpan Hopital Rangueil /ID# 131035
  • Bouches-du-Rhone
    • Marseille, Bouches-du-Rhone, France, 13008
      • Hopital Saint Joseph /ID# 132177
  • Franche-Comte
    • Limoges CEDEX 1, Franche-Comte, France, 87042
      • CHU Limoges - Dupuytren 1 /ID# 131038
  • Gironde
    • Pessac CEDEX, Gironde, France, 33604
      • Hopital Haut-Lévêque /ID# 131036
  • Herault
    • Montpellier CEDEX 5, Herault, France, 34295
      • Hopital Saint Eloi /ID# 131037
  • Pays-de-la-Loire
    • Nantes, Pays-de-la-Loire, France, 44000
      • CHU de Nantes, Hotel Dieu -HME /ID# 132179
• Germany
  • Berlin, Germany, 13353
    • Medizinische Klinik mit Schwerpunkt Hepatologie und Gastroenterologie /ID# 131053
  • Essen, Germany, 45147
    • Universitaetsklinikum Essen /ID# 131048
  • Hamburg, Germany, 20246
    • Universitaetsklinikum Hamburg-Eppendorf (UKE) /ID# 131051
  • Hannover, Germany, 30625
    • Medizinische Hochschule Hannover /ID# 131054
  • Muenster, Germany, 48143
    • Centrum für interdisziplinaere Medizin /ID# 131046
  • Baden-Wuerttemberg
    • Freiburg, Baden-Wuerttemberg, Germany, 79106
      • Universitaetsklinikum Freiburg /ID# 131044
    • Heidelberg, Baden-Wuerttemberg, Germany, 69120
      • Universitaetsklinik Heidelberg /ID# 134371
    • Tubingen, Baden-Wuerttemberg, Germany, 72076
      • Universitaetsklinikum Tuebingen Medizinische Klinik /ID# 131045
  • Bayern
    • Munich, Bayern, Germany, 81377
      • LMU Klinikum der Universitat Muchen /ID# 131049
  • Hessen
    • Frankfurt am Main, Hessen, Germany, 60590
      • Universitaetsklinikum Frankfurt /ID# 131055
  • Nordrhein-Westfalen
    • Düsseldorf, Nordrhein-Westfalen, Germany, 40237
      • Zentru fur HIV und Heaptogastroenterologie /ID# 131052
    • Herne, Nordrhein-Westfalen, Germany, 44623
      • Gastroenterologische Gemeinschaftspraxis Herne /ID# 131050
• Greece
  • Alexandroupolis, Greece, 68100
    • General University Hospital of Alexandroupolis /ID# 131056
  • Attiki
    • Athens, Attiki, Greece, 11527
      • General Hospital of Athens Laiko /ID# 131088
    • Athens, Attiki, Greece, 11527
      • General Hospital of Athens Ippokratio /ID# 131057
• Ireland
  • Dublin
    • Beaumont, Dublin, Ireland, D09 XR63
      • Beaumont Hospital /ID# 131089
    • Dublin 8, Dublin, Ireland, D08 NHY1
      • St James Hospital /ID# 132180
    • Elm Park, Dublin, Ireland, D04 T6F4
      • St Vincent's University Hospital /ID# 132181
• Israel
  • Haifa, Israel, 3109601
    • Rambam Health Care Campus /ID# 131090
  • Haifa, Israel, 34362
    • The Lady Davis Carmel Medical Center /ID# 131091
  • Tel-Aviv
    • Ramat Gan, Tel-Aviv, Israel, 5265601
      • The Chaim Sheba Medical Center /ID# 131092
    • Tel Aviv-Yafo, Tel-Aviv, Israel, 6423906
      • Tel Aviv Sourasky Medical Center /ID# 132182
• Italy
  • Bergamo, Italy, 24127
    • Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII (Presidio Papa Giovanni /ID# 132188
  • Florence, Italy, 50134
    • Azienda Ospedaliero Universitaria Careggi /ID# 132197
  • Foggia, Italy, 71122
    • Azienda Ospedaliera Universitaria Ospedali Riuniti /ID# 132195
  • Messina, Italy, 98125
    • A.O.U. Policlinico G. Martino /ID# 132193
  • Milan, Italy, 20123
    • Ospedale S Giuseppe /ID# 132194
  • Milan, Italy, 20122
    • Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico /ID# 131097
  • Milan, Italy, 20142
    • ASST Santi Paolo e Carlo/Presidio Ospedale San Paolo /ID# 132198
  • Milano, Italy, 20157
    • ASST Fatebenefratelli Sacco-Ospedale Sacco /ID# 134372
  • Milano, Italy, 20162
    • Azienda Ospedaliera Niguarda Ca' Granda Hospital /ID# 131104
  • Napoli, Italy, 80131
    • Azienda Ospedaliera Universitaria Federico II /ID# 131096
  • Napoli, Italy, 80131
    • Azienda Ospedaliera Universitaria Federico II /ID# 132191
  • Palermo, Italy, 90127
    • Azienda Ospedaliera Universitaria Paolo Giaccone /ID# 132184
  • Parma, Italy, 43126
    • Azienda Ospedaliero-Universitaria di Parma /ID# 132183
  • Salerno, Italy, 84131
    • Azienda Ospedaliera Universitaria "San Giovanni di Dio e Ruggi d'Aragona /ID# 132192
  • Turin, Italy, 10126
    • A.O.U. Citta della Salute e della Scienza di Torino /ID# 131100
  • Udine, Italy, 33100
    • Azienda Ospedaliera Universitaria Friuli Centrale/Presidio Ospedaliero Universit /ID# 132196
  • Emilia-Romagna
    • Bologna, Emilia-Romagna, Italy, 40138
      • Duplicate_A.O.U. Policlinico S.Orsola-Malpighi /ID# 131095
  • Ferrara
    • Cona, Ferrara, Italy, 44124
      • Azienda Ospedaliero-Universitaria di Ferrara-Arcispedale Sant Anna /ID# 131102
  • Foggia
    • San Giovanni Rotondo, Foggia, Italy, 71013
      • Fondazione di Religione e di Culto Casa Sollievo della Sofferenza /ID# 132190
  • Lazio
    • Rome, Lazio, Italy, 00168
      • Policlinico Agostino Gemelli /ID# 131098
  • Lombardia
    • Milan, Lombardia, Italy, 20132
      • Ospedale San Raffaele IRCCS /ID# 131093
  • Roma
    • Rome, Roma, Italy, 00133
      • Fondazione PTV Policlinico Tor Vergata /ID# 132185
• Mexico
  • Ciudad de Mexico, Mexico, 14380
    • ITESM campus Ciudad de Mexico /ID# 132383
  • Delegacion Tlalpan, Mexico, 14308
    • Instituto Metropolitano de Inv /ID# 132201
  • Distrito Federal, Mexico, 14000
    • Instituto Nacional de Clencias Medicas y Nutricion Salvador Zubrian Departament /ID# 130975
  • Mexico City, Mexico, 14050
    • CIF-BIOTEC/Medica Sur /ID# 134971
  • Baja California
    • Tijuana, Baja California, Mexico, 22680
      • Hospital General de Tijuana /ID# 130972
  • Jalisco
    • Guadalajara, Jalisco, Mexico, 44160
      • Cife /Id# 130974
• Netherlands
  • Amsterdam, Netherlands, 1105 AZ
    • Academisch Medisch Centrum /ID# 132205
  • Leiden, Netherlands, 2333 ZA
    • Leids Universitair Medisch Centrum /ID# 132204
  • Zuid-Holland
    • Rotterdam, Zuid-Holland, Netherlands, 3015 GD
      • Erasmus Medisch Centrum /ID# 132206
• Norway
  • Stavanger, Norway, 4068
    • Stavanger University Hospital /ID# 132211
  • Akershus
    • Lorenskog, Akershus, Norway, 1478
      • Akershus Universitetssykehus_MAIN /ID# 132212
  • Sor-Trondelag
    • Trondheim, Sor-Trondelag, Norway, 7006
      • St. Olavs Hospital HF /ID# 132213
• Poland
  • Kujawsko-pomorskie
    • Bydgoszcz, Kujawsko-pomorskie, Poland, 85-030
      • Wojewodzki Szpital Obserwacyjno-Zakazny im. Tadeusza Browicza /ID# 131106
  • Lodzkie
    • Lodz, Lodzkie, Poland, 91-347
      • Wojewodzki Specjalistyczny Szpital im. dr. W. Bieganskiego /ID# 131107
  • Lubelskie
    • Lublin, Lubelskie, Poland, 20-081
      • Samodzielny Publiczny Szpital Kliniczny Nr 1 w Lublinie /ID# 131115
  • Mazowieckie
    • Warsaw, Mazowieckie, Poland, 01-201
      • Wojewodzki Szpital Zakazny /ID# 131112
  • Podlaskie
    • Bialystok, Podlaskie, Poland, 15-276
      • Uniwersytecki Szpital Kliniczny w Bialymstoku /ID# 131108
  • Slaskie
    • Myslowice, Slaskie, Poland, 41-406
      • ID Clinic /ID# 131111
• Portugal
  • Coimbra, Portugal, 3000-075
    • Centro Hospitalar e Universitario de Coimbra, EPE /ID# 131119
  • Lisboa, Portugal, 1649-035
    • Centro Hospitalar Universitário de Lisboa Norte, EPE - Hospital de Santa Maria /ID# 131118
  • Lisboa, Portugal, 1169-050
    • Centro Hospitalar Universitario Lisboa Central, EPE - Hospital dos Capuchos /ID# 131116
  • Porto, Portugal, 4099-001
    • Centro Hospitalar Universitário do Porto, EPE - Hospital Santo António /ID# 131117
• Romania
  • Bucuresti, Romania, 010825
    • Institutul Nat. de Boli Infectioase /ID# 131124
  • Iasi, Romania, 700506
    • SC Gastromedica SRL /ID# 131127
  • Bucuresti
    • Sector 2, Bucuresti, Romania, 022328
      • Institutul Clinic Fundeni /ID# 131121
    • Sector 2, Bucuresti, Romania, 021105
      • Duplicate_Institutul National de Boli Infectioase Prof. Dr. Matei Bals /ID# 131120
  • Timis
    • Timisoara, Timis, Romania, 300310
      • Spitalul Clinic de Boli Infectioase Si Pneumoftiziologie Dr. Victor Babes /Id# 131126
• Russian Federation
  • Chelyabinsk, Russian Federation, 454052
    • South-Ural State Med. Academy /ID# 132274
  • Kemerovo, Russian Federation, 650056
    • Kuzbass Center for Prevention and Fight agains AIDS /ID# 132269
  • Krasnoyarsk, Russian Federation, 660049
    • Krasnoyarsk Regional Center for the Prevention and Control of AIDS /ID# 132278
  • Moscow, Russian Federation, 119991
    • I. M. Sechenov First Moscow State Medical University /ID# 132275
  • Moscow, Russian Federation, 127015
    • City Clinical Hospital #24 /ID# 132268
  • Moscow, Russian Federation, 129090
    • Research Institute of Emergency Medicine named after V.I. N.V. Sklifosovsky /ID# 132288
  • Moscow, Russian Federation, 111123
    • Moscow Clinical Scientific Center n.a. Loginov /ID# 132266
  • Moscow, Russian Federation, 117593
    • Central Clinical Hospital of Russian Academy of Science /ID# 132289
  • Novosibirsk, Russian Federation, 630099
    • Clinical Infectious Diseases Hospital #1 /ID# 132272
  • Samara, Russian Federation, 443099
    • Samara State Medical University /ID# 136913
  • Stavropol, Russian Federation, 355017
    • Stavropol State Medical University /ID# 132279
  • Tolyatti, Russian Federation, 445009
    • Tolyatti City Clinical Hospital #1 /ID# 132273
  • Tyumen, Russian Federation, 625026
    • Multidisciplinary Consultative and Diagnostic Center /ID# 131130
  • Yekaterinburg, Russian Federation, 620102
    • Sverdlovsk Regional Clinical Hospital #1 /ID# 132267
  • Samarskaya Oblast
    • Samara, Samarskaya Oblast, Russian Federation, 443063
      • Medical Company Hepatolog /ID# 132277
  • Tatarstan, Respublika
    • Kazan, Tatarstan, Respublika, Russian Federation, 420140
      • Republican Clinical Infectious Diseases Hospital n.a. Professor A. F. Agafonov /ID# 132270
• Saudi Arabia
  • Jeddah, Saudi Arabia, 21423
    • King Abdulaziz Medical City /ID# 145129
  • Riyadh, Saudi Arabia, 11426
    • Ministry Nat Guard Hosp Health /ID# 145126
  • Riyadh, Saudi Arabia, 11472
    • King Khalid University Hospita /ID# 132291
• Spain
  • A Coruna, Spain, 15006
    • Hospital Universitario A Coruna - CHUAC /ID# 131137
  • Cordoba, Spain, 14004
    • Hospital Universitario Reina Sofia /ID# 131135
  • Madrid, Spain, 28006
    • Hospital Universitario de la Princesa /ID# 131131
  • Madrid, Spain, 28041
    • Hospital Universitario 12 de Octubre /ID# 131133
  • Madrid, Spain, 28046
    • Hospital Universitario La Paz /ID# 131132
  • Malaga, Spain, 29010
    • Hospital Universitario Virgen de la Victoria /ID# 131136
  • Sevilla, Spain, 41013
    • Hospital Universitario Virgen del Rocio /ID# 131134
  • Zaragoza, Spain, 50009
    • Hospital Clinico Universitario Lozano Blesa /ID# 132292
  • Asturias
    • Oviedo, Asturias, Spain, 33011
      • Hospital Universitario Central de Asturias /ID# 131138
  • Barcelona
    • Badalona, Barcelona, Spain, 08916
      • Hospital Universitario Germans Trias i Pujol /ID# 132293
  • Cantabria
    • Santander, Cantabria, Spain, 39008
      • Hospital Unversitario Marques de Valdecilla /ID# 131141
  • Guipuzcoa
    • Donostia, Guipuzcoa, Spain, 20014
      • Hospital Donostia /ID# 131144
  • Illes Balears
    • Palma de Mallorca, Illes Balears, Spain, 07120
      • Hospital Universitari Son Espases /ID# 131140
  • Murcia
    • Cartagena, Murcia, Spain, 30202
      • Hospital General Universitario Santa Lucia /ID# 131139
  • Vizcaya
    • Barakaldo, Vizcaya, Spain, 48903
      • OSI Ezkerraldea-Enkarterri-Cruces /ID# 131143
• Sweden
  • Skane Lan
    • Malmo, Skane Lan, Sweden, 214 28
      • Skane University hospital /ID# 131146
  • Stockholms Lan
    • Solna, Stockholms Lan, Sweden, 171 64
      • Karolinska University Hospital Solna /ID# 131145
  • Vastra Gotalands Lan
    • Gothenburg, Vastra Gotalands Lan, Sweden, 413 45
      • Sahlgrenska University Hospital /ID# 131147
• Switzerland
  • Bern, Switzerland, 3010
    • Inselspital, Universitätsspital Bern /ID# 132294
  • Sankt Gallen
    • St. Gallen, Sankt Gallen, Switzerland, 9007
      • Kantonsspital St. Gallen /ID# 131148
  • Zuerich
    • Zürich, Zuerich, Switzerland, 8091
      • Universitätsspital Zürich /ID# 134881
• Turkey
  • Ankara, Turkey, 06100
    • Hacettepe University Faculty of Medicine /ID# 131150
  • Ankara, Turkey, 06590
    • Ankara Univ Medical Faculty /ID# 131151
  • Bursa, Turkey, 16059
    • Uludag University Medical Faculty /ID# 132297
  • Istanbul, Turkey, 34093
    • Istanbul University Istanbul Medical Faculty /ID# 131153
  • Izmir, Turkey, 35040
    • Ege University Medical Faculty /ID# 132298
  • Trabzon, Turkey, 61000
    • Karadeniz University /ID# 131152
  • Izmir
    • Konak, Izmir, Turkey, 35180
      • Izmir Tepecik Training and Research Hospital /ID# 134968
• United Kingdom
  • Birmingham, United Kingdom, B15 2TH
    • University Hospitals Birmingham NHS Foundation Trust /ID# 131154
  • Dundee, United Kingdom, DD2 1UB
    • Duplicate_NHS Tayside /ID# 132300
  • Edinburgh, United Kingdom, EH3 9HE
    • NHS Lothian /ID# 134368
  • Leeds, United Kingdom, LS9 7TF
    • Leeds Teaching Hospitals NHS Trust /ID# 132305
  • London, United Kingdom, SE5 9RS
    • King's College Hospital NHS Foundation Trusts /ID# 131157
  • Plymouth, United Kingdom, PL6 5FP
    • University Hospital Plymouth NHS Trust /ID# 131160
  • Portsmouth, United Kingdom, PO6 3LY
    • Portsmouth Hospitals University NHS Trust /ID# 131158
  • Salford, United Kingdom, M6 8HD
    • Northern Care Alliance NHS Group /ID# 131156
  • Tooting, United Kingdom, SW17 0QT
    • St George's University Hospitals NHS Foundation Trust /ID# 132301
  • Dorset
    • Poole, Dorset, United Kingdom, BH15 2JB
      • Duplicate_University Hospitals Dorset NHS Foundation Trust /ID# 132306
  • Hampshire
    • Southampton, Hampshire, United Kingdom, SO16 6YD
      • University Hospital Southampton NHS Foundation Trust /ID# 131161
  • London, City Of
    • London, London, City Of, United Kingdom, E1 2ES
      • Barts Health NHS Trust /ID# 132302
    • London, London, City Of, United Kingdom, NW3 2QG
      • The Royal Free London NHS Foundation Trust /ID# 131159
  • Nottinghamshire
    • Nottingham, Nottinghamshire, United Kingdom, NG5 1PB
      • Duplicate_Nottingham University Nottingham University Hospitals NHS Trust /ID# 131155
  • Scotland
    • Glasgow, Scotland, United Kingdom, G12 0XH
      • NHS Greater Glasgow and Clyde /ID# 131162

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 99 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Males and females at least 18 years old at screening
2. Females must be post-menopausal for more than 2 years or surgically sterile or practicing acceptable forms of birth control
3. Chronic hepatitis C, genotype 1 infection
4. Males must be surgically sterile or agree to practice acceptable forms of birth control
5. Screening laboratory result indicating HCV genotype 1 infection

Exclusion Criteria:

1. Use of contraindicated medications within 2 weeks of dosing
2. Abnormal laboratory tests
3. Current or past clinical evidence of Child-Pugh B or C classification or history of liver decompensation
4. Confirmed presence of hepatocellular carcinoma
5. History of solid organ transplant

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: ABT-450/r/ABT-267 plus ABT-333 with or without ribavirin (RBV); Participants with HCV GT1b without cirrhosis received the 3-DAA (ABT-450/ritonavir/ABT-267 and ABT-333) regimen: two 75 mg ABT-450/50 mg ritonavir/12.5 mg ABT-267 tablets taken orally every morning (QD) and one ABT-333 250 mg tablet taken orally twice a day (BID) for 12 weeks. Participants with HCV GT1a without cirrhosis and those with HCV GT1b with cirrhosis received the 3-DAA regimen and weight-based ribavirin (RBV; 1000 to 1200 mg divided twice daily per local label) for 12 weeks. Participants with HCV GT1a with cirrhosis received the 3-DAA regimen and weight-based RBV per local label for 24 weeks.

Drug: ABT-450/r/ABT-267; Tablet for oral use; Other Names: ABT-267 also known as ombitasvir; ABT-450 also known as paritaprevir; Paritaprevir/ritonavir/ombitasvir also known as Viekirax; Drug: ABT-333; Tablet for oral use; Other Names: ABT-333 also known as dasabuvir; ABT-333 also known as Exviera; Drug: Ribavirin (RBV); Ribavirin was provided as 200 mg tablets, and dosed based on weight,1000 to 1200 mg divided twice daily per local label. For example, for participants weighing < 75 kg, RBV may have been taken orally as 2 tablets in the morning and 3 tablets in the evening which corresponds to a 1000 mg total daily dose. For participants weighing ≥ 75 kg, RBV may have been taken orally as 3 tablets in the morning and 3 tablets in the evening which corresponds to a 1200 mg total daily dose.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
All-Cause Death: Time to Event	Time to all-cause death was defined as the number of days from the first day of study drug dosing for the participant to the date of death. All deaths were to be included, regardless of whether the death occurred while the participant was still taking study drug or had previously discontinued study drug. If the participant did not die, their data was to be censored at the date of their last available assessment of clinical outcomes. For participants with no post-baseline assessment, the participant's data was to be censored on the first day of study drug dosing. The event-free survival rates were estimated using Kaplan-Meier methodology and incidence estimates are presented with 95% confidence intervals. The pre-specified analysis of all-cause death included pooled data from TOPAZ-I (this study) and the companion study TOPAZ-II (M14-222; NCT02167945).	At Post-Treatment Weeks 52, 104, 156, 208, and 260
Liver-Related Death: Time to Event	Time to liver-related death was defined as days from the 1st day of study drug dosing for the subject to date of liver-related death. All liver-related deaths were to be included, regardless of whether the death occurred while subject was still taking study drug or had previously discontinued study drug. If the subject didn't experience event of interest nor had died (all-cause death), their data was to be censored at date of last available assessment. For those with no post-baseline assessment, data was to be censored on 1st day of study drug dosing. All-cause death was a censoring event for liver-related death. The event-free survival rates were estimated using Kaplan-Meier methodology and incidence estimates are presented with 95% confidence intervals. The pre-specified analysis of liver-related death included pooled data from TOPAZ-I (this study) and the companion study TOPAZ-II (M14-222; NCT02167945).	At Post-Treatment Weeks 52, 104, 156, 208, and 260
Liver Decompensation: Time to Event	Time to liver decompensation was defined as number of days from the 1st day of study drug dosing for the participant to the date of liver decompensation. All liver decompensation was to be included, regardless of whether it occurred while the participant was still taking study drug or had previously discontinued study drug. If the participant didn't experience the event of interest nor had died (all-cause death), their data was to be censored at the date of their last available assessment of clinical outcomes. For participants with no post-baseline assessment, their data was to be censored on the 1st day of study drug dosing. All-cause death was a censoring event for liver decompensation. The event-free survival rates were estimated using Kaplan-Meier methodology and incidence estimates are presented with 95% confidence intervals. The pre-specified analysis of liver decompensation included pooled data from TOPAZ-I (this study) and the companion study TOPAZ-II (M14-222; NCT02167945).	At Post-Treatment Weeks 52, 104, 156, 208, and 260
Liver Transplantation: Time to Event	Time to liver transplantation was defined as days from 1st day of study drug dosing for subject to date of liver transplantation. All liver transplantation was to be included, whether it occurred while the subject was still taking study drug or had previously discontinued study drug. If the subject didn't experience event of interest nor had died (all-cause death), their data was to be censored at the date of their last available assessment. For those with no post-baseline assessment, data was to be censored on 1st day of study drug dosing. All-cause death was a censoring event for liver transplantation. The event-free survival rates were estimated using Kaplan-Meier methodology and incidence estimates are presented with 95% confidence intervals. The pre-specified analysis of liver transplantation included pooled data from TOPAZ-I (this study) and the companion study TOPAZ-II (M14-222; NCT02167945).	At Post-Treatment Weeks 52, 104, 156, 208, and 260
Hepatocellular Carcinoma: Time to Event	Time to hepatocellular carcinoma (HCC) was defined as number of days from 1st day of study drug dosing for subject to date of hepatocellular carcinoma. All HCC was to be included, whether it occurred while subject was still taking study drug or had previously discontinued study drug. If the subject didn't experience the event of interest nor had died (all-cause death), their data was to be censored at the date of their last available assessment. For those with no post-baseline assessment, their data was to be censored on the 1st day of study drug dosing. All-cause death was a censoring event for HCC. The event-free survival rates were estimated using Kaplan-Meier methodology and incidence estimates are presented with 95% confidence intervals. The pre-specified analysis of hepatocellular carcinoma included pooled data from TOPAZ-I (this study) and the companion study TOPAZ-II (M14-222; NCT02167945).	At Post-Treatment Weeks 52, 104, 156, 208, and 260
All-Cause Death, Liver-Related Death, Liver Decompensation, Liver Transplantation, Hepatocellular Carcinoma: Time to Event	Time to the composite of clinical outcomes is the time to the first occurrence of all-cause death, liver-related death, liver decompensation, liver transplantation, or hepatocellular carcinoma. All first occurrences were to be included, regardless of whether it occurred while the participant was still taking study drug or had previously discontinued study drug. If the participant did not experience any of these events, their data was to be censored at the date of their last available assessment of clinical outcomes. For participants with no post-baseline assessment, the participant's data was to be censored on the first day of study drug dosing. The event-free survival rates were estimated using Kaplan-Meier methodology and incidence estimates are presented with 95% confidence intervals. Pre-specified analysis included pooled data from this study and from TOPAZ-II; NCT02167945.	At Post-Treatment Weeks 52, 104, 156, 208, and 260

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change From Baseline in FibroScan Score by SVR12 Status	The FibroScan test is a validated non-invasive test used to assess liver fibrosis in participants with chronic liver disease, and it was performed at study sites where it was available. For participants with Hepatitis C infection, a FibroScan score of 2-7 kPa indicates no liver scarring or mild scarring; a score of 8 or 9 is associated with moderate liver scarring; 9-14 indicates severe liver scarring; and 14 or higher is indicative of advanced liver scarring, cirrhosis. Negative changes from baseline indicate improvement in liver fibrosis.	At the final treatment visit and Post-Treatment Weeks 12, 24, 52, 104, 156, 208, and 260
Percentage of Participants With Sustained Virologic Response 12 Weeks Post-treatment (SVR12)	SVR12 is defined as hepatitis C virus ribonucleic acid (HCV RNA) less than the lower limit of quantification (LLOQ) 12 weeks after the last actual dose of study drug. Flanking imputation, where applicable, was used to impute missing data. After applying flanking imputation, if there was no value in the window but there was an HCV RNA value from a local laboratory present, then it was to be imputed into the SVR window. Otherwise, participants with missing data were counted as failures.	12 weeks after the last actual dose of study drug

Collaborators and Investigators

• Sponsor: AbbVie

Study record dates

Study Major Dates

• Study Start (Actual): October 30, 2014
• Primary Completion (Actual): May 13, 2021
• Study Completion (Actual): May 13, 2021

Study Registration Dates

• First Submitted: August 15, 2014
• First Submitted That Met QC Criteria: August 15, 2014
• First Posted (Estimate): August 19, 2014

Study Record Updates

• Last Update Posted (Actual): April 7, 2023
• Last Update Submitted That Met QC Criteria: June 27, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Keywords: Cirrhosis; Compensated Cirrhosis; Hepatitis C Genotype 1; Hepatitis C; Hepatitis C Virus; Naive; Relapser; Treatment-Experienced; Non responder; Null responder
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; RNA Virus Infections; Virus Diseases; Blood-Borne Infections; Disease Attributes; Liver Diseases; Flaviviridae Infections; Hepatitis, Viral, Human; Enterovirus Infections; Picornaviridae Infections; Infections; Communicable Diseases; Hepatitis; Hepatitis A; Hepatitis C; Hepatitis, Chronic; Hepatitis C, Chronic; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Antiviral Agents; Enzyme Inhibitors; Anti-HIV Agents; Anti-Retroviral Agents; Antimetabolites; Protease Inhibitors; Cytochrome P-450 CYP3A Inhibitors; Cytochrome P-450 Enzyme Inhibitors; HIV Protease Inhibitors; Viral Protease Inhibitors; Ribavirin; Ritonavir
• Other Study ID Numbers: M14-423; 2014-001022-14 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols and clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications
• IPD Sharing Time Frame: For details on when studies are available for sharing, please refer to the link below.
• IPD Sharing Access Criteria: Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous, independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Use Agreement (DUA). For more information on the process, or to submit a request, visit the following link.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No