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

NCT ID: NCT02219490

Last Updated: 2023-04-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 1596 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-10-30
• Study Completion Date: 2021-05-13

Brief Summary

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.

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.

Conditions

Chronic Hepatitis C Virus (HCV) Infection Genotype 1

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

ABT-450/r/ABT-267

Intervention Type: DRUG

Tablet for oral use

ABT-333

Intervention Type: DRUG

Tablet for oral use

Ribavirin (RBV)

Intervention Type: DRUG

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.

Interventions

ABT-450/r/ABT-267

Tablet for oral use

Intervention Type: DRUG

ABT-333

Tablet for oral use

Intervention Type: 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.

Intervention Type: DRUG

Other Intervention Names

ABT-450 also known as paritaprevir; ABT-267 also known as ombitasvir; Paritaprevir/ritonavir/ombitasvir also known as Viekirax; ABT-333 also known as dasabuvir; ABT-333 also known as Exviera

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

AbbVie

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

ABBVIE INC.

Role: STUDY_DIRECTOR

AbbVie

Locations

CHU Bab El Oued /ID# 145420

Algiers, , Algeria

CHU Bologhine Hospital /ID# 145421

Algiers, , Algeria

CHU Mustapha Bacha /ID# 132130

Algiers, , Algeria

St Vincent's Hospital Sydney /ID# 131001

Darlinghurst, New South Wales, Australia

Nepean Hospital /ID# 130999

Kingswood, New South Wales, Australia

Westmead Hospital /ID# 130997

Westmead, New South Wales, Australia

Greenslopes Private Hospital /ID# 131003

Greenslopes, Queensland, Australia

Royal Brisbane and Women's Hospital /ID# 131004

Herston, Queensland, Australia

Royal Adelaide Hospital /ID# 131002

Adelaide, South Australia, Australia

St Vincent's Hospital Melbourne /ID# 131000

Fitzroy Melbourne, Victoria, Australia

The Royal Melbourne Hospital /ID# 130998

Parkville, Victoria, Australia

Medizinische Universitaet Graz /ID# 131018

Graz, Styria, Austria

Ordensklinikum Linz GmbH Elisabethinen /ID# 131017

Linz, Upper Austria, Austria

Medizinische Universitaet Wien /ID# 131015

Vienna, Vienna, Austria

Cliniques Universitaires de Bruxelles Hopital Erasme /ID# 131020

Brussels, Brussels Capital, Belgium

UCL Saint-Luc /ID# 131019

Woluwe-Saint-Lambert, Brussels Capital, Belgium

Universitair Ziekenhuis Leuven /ID# 131021

Leuven, Vlaams-Brabant, Belgium

Tokuda Hospital Sofia /ID# 131022

Sofia, , Bulgaria

UMHAT Sveti Ivan Rilski /ID# 131026

Sofia, , Bulgaria

Univ Hosp for Active Treat /ID# 131023

Sofia, , Bulgaria

Diagnostic Consultative Center /ID# 131027

Sofia, , Bulgaria

UMHAT Sveta Marina /ID# 131025

Varna, , Bulgaria

University of Calgary /ID# 134370

Calgary, Alberta, Canada

GI Research & Associates /ID# 132169

Edmonton, Alberta, Canada

LAIR Centre /ID# 130970

Vancouver, British Columbia, Canada

Vancouver Infectious Diseases Centre /ID# 134369

Vancouver, British Columbia, Canada

GIRI Gastrointestinal Research Institute /ID# 132171

Vancouver, British Columbia, Canada

University of Manitoba / Health Scuience Centre / John Buhler Research Centre /ID# 130969

Winnipeg, Manitoba, Canada

Saint John Regional Hospital /ID# 131210

Saint John, New Brunswick, Canada

Ottawa Hospital Research Institute /ID# 132170

Ottawa, Ontario, Canada

Toronto General Hospital /ID# 132134

Toronto, Ontario, Canada

Toronto Liver Centre /ID# 132168

Toronto, Ontario, Canada

Toronto Digestive Disease Asso /ID# 130968

Vaughan, Ontario, Canada

Clinique Medicale L'Actuel /ID# 132167

Montreal, Quebec, Canada

Jewish General Hospital /ID# 132165

Montreal, Quebec, Canada

Royal Victoria Hospital / McGill University Health Centre /ID# 132166

Montreal, Quebec, Canada

CHU de Quebec-Université Laval hôpital CHUL /ID# 132132

Québec, Quebec, Canada

Kobenhavns Universitet - Hvidovre Hospital (HH) /ID# 131031

Hvidovre, Capital Region, Denmark

Odense University Hospital /ID# 131029

Odense C, Region Syddanmark, Denmark

Aarhus Univ Hospital, Skejby /ID# 131030

Aarhus, , Denmark

Helsinki University Hospital /ID# 131034

Helsinki, Uusimaa, Finland

Turku University Hospital /ID# 131032

Turku, , Finland

Hopital Saint Joseph /ID# 132177

Marseille, Bouches-du-Rhone, France

CHU Limoges - Dupuytren 1 /ID# 131038

Limoges, Franche-Comte, France

Hopital Haut-Lévêque /ID# 131036

Pessac, Gironde, France

Hopital Saint Eloi /ID# 131037

Montpellier, Herault, France

CHU de Nantes, Hotel Dieu -HME /ID# 132179

Nantes, Pays de la Loire Region, France

Hopital Jean Verdier /ID# 135877

Bondy, , France

CHU Grenoble - Hopital Michallon /ID# 131041

La Tronche, , France

HCL - Hopital de la Croix-Rousse /ID# 131042

Lyon, , France

Duplicate_Hopital lArchet 2 /ID# 131040

Nice, , France

CHRU Pontchaillou /ID# 132173

Rennes, , France

CHU Strasbourg - Hopital Civil /ID# 132174

Strasbourg, , France

Hopital Universitaire Purpan Hopital Rangueil /ID# 131035

Toulouse, , France

Universitaetsklinikum Freiburg /ID# 131044

Freiburg im Breisgau, Baden-Wurttemberg, Germany

Universitaetsklinik Heidelberg /ID# 134371

Heidelberg, Baden-Wurttemberg, Germany

Universitaetsklinikum Tuebingen Medizinische Klinik /ID# 131045

Tübingen, Baden-Wurttemberg, Germany

LMU Klinikum der Universitat Muchen /ID# 131049

Munich, Bavaria, Germany

Universitaetsklinikum Frankfurt /ID# 131055

Frankfurt am Main, Hesse, Germany

Zentru fur HIV und Heaptogastroenterologie /ID# 131052

Düsseldorf, North Rhine-Westphalia, Germany

Gastroenterologische Gemeinschaftspraxis Herne /ID# 131050

Herne, North Rhine-Westphalia, Germany

Medizinische Klinik mit Schwerpunkt Hepatologie und Gastroenterologie /ID# 131053

Berlin, , Germany

Universitaetsklinikum Essen /ID# 131048

Essen, , Germany

Universitaetsklinikum Hamburg-Eppendorf (UKE) /ID# 131051

Hamburg, , Germany

Medizinische Hochschule Hannover /ID# 131054

Hanover, , Germany

Centrum für interdisziplinaere Medizin /ID# 131046

Münster, , Germany

General Hospital of Athens Ippokratio /ID# 131057

Athens, Attica, Greece

General Hospital of Athens Laiko /ID# 131088

Athens, Attica, Greece

General University Hospital of Alexandroupolis /ID# 131056

Alexandroupoli, , Greece

Beaumont Hospital /ID# 131089

Beaumont, Dublin, Ireland

St James Hospital /ID# 132180

Dublin, Dublin, Ireland

St Vincent's University Hospital /ID# 132181

Elm Park, Dublin, Ireland

The Chaim Sheba Medical Center /ID# 131092

Ramat Gan, Tel Aviv, Israel

Tel Aviv Sourasky Medical Center /ID# 132182

Tel Aviv, Tel Aviv, Israel

Rambam Health Care Campus /ID# 131090

Haifa, , Israel

The Lady Davis Carmel Medical Center /ID# 131091

Haifa, , Israel

Duplicate_A.O.U. Policlinico S.Orsola-Malpighi /ID# 131095

Bologna, Emilia-Romagna, Italy

Azienda Ospedaliero-Universitaria di Ferrara-Arcispedale Sant Anna /ID# 131102

Cona, Ferrara, Italy

Fondazione di Religione e di Culto Casa Sollievo della Sofferenza /ID# 132190

San Giovanni Rotondo, Foggia, Italy

Policlinico Agostino Gemelli /ID# 131098

Rome, Lazio, Italy

Ospedale San Raffaele IRCCS /ID# 131093

Milan, Lombardy, Italy

Fondazione PTV Policlinico Tor Vergata /ID# 132185

Rome, Roma, Italy

Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII (Presidio Papa Giovanni /ID# 132188

Bergamo, , Italy

Azienda Ospedaliero Universitaria Careggi /ID# 132197

Florence, , Italy

Azienda Ospedaliera Universitaria Ospedali Riuniti /ID# 132195

Foggia, , Italy

A.O.U. Policlinico G. Martino /ID# 132193

Messina, , Italy

Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico /ID# 131097

Milan, , Italy

Ospedale S Giuseppe /ID# 132194

Milan, , Italy

ASST Santi Paolo e Carlo/Presidio Ospedale San Paolo /ID# 132198

Milan, , Italy

ASST Fatebenefratelli Sacco-Ospedale Sacco /ID# 134372

Milan, , Italy

Azienda Ospedaliera Niguarda Ca' Granda Hospital /ID# 131104

Milan, , Italy

Azienda Ospedaliera Universitaria Federico II /ID# 131096

Napoli, , Italy

Azienda Ospedaliera Universitaria Federico II /ID# 132191

Napoli, , Italy

Azienda Ospedaliera Universitaria Paolo Giaccone /ID# 132184

Palermo, , Italy

Azienda Ospedaliero-Universitaria di Parma /ID# 132183

Parma, , Italy

Azienda Ospedaliera Universitaria "San Giovanni di Dio e Ruggi d'Aragona /ID# 132192

Salerno, , Italy

A.O.U. Citta della Salute e della Scienza di Torino /ID# 131100

Turin, , Italy

Azienda Ospedaliera Universitaria Friuli Centrale/Presidio Ospedaliero Universit /ID# 132196

Udine, , Italy

Hospital General de Tijuana /ID# 130972

Tijuana, Estado de Baja California, Mexico

Cife /Id# 130974

Guadalajara, Jalisco, Mexico

Instituto Nacional de Clencias Medicas y Nutricion Salvador Zubrian Departament /ID# 130975

Distrito Federal, , Mexico

CIF-BIOTEC/Medica Sur /ID# 134971

Mexico City, , Mexico

ITESM campus Ciudad de Mexico /ID# 132383

Mexico City, , Mexico

Instituto Metropolitano de Inv /ID# 132201

Tlalpan, , Mexico

Erasmus Medisch Centrum /ID# 132206

Rotterdam, South Holland, Netherlands

Academisch Medisch Centrum /ID# 132205

Amsterdam, , Netherlands

Leids Universitair Medisch Centrum /ID# 132204

Leiden, , Netherlands

Akershus Universitetssykehus_MAIN /ID# 132212

Lorenskog, Akershus, Norway

St. Olavs Hospital HF /ID# 132213

Trondheim, Sor-Trondelag, Norway

Stavanger University Hospital /ID# 132211

Stavanger, , Norway

Wojewodzki Szpital Obserwacyjno-Zakazny im. Tadeusza Browicza /ID# 131106

Bydgoszcz, Kuyavian-Pomeranian Voivodeship, Poland

Samodzielny Publiczny Szpital Kliniczny Nr 1 w Lublinie /ID# 131115

Lublin, Lublin Voivodeship, Poland

Wojewodzki Szpital Zakazny /ID# 131112

Warsaw, Masovian Voivodeship, Poland

Uniwersytecki Szpital Kliniczny w Bialymstoku /ID# 131108

Bialystok, Podlaskie Voivodeship, Poland

ID Clinic /ID# 131111

Mysłowice, Silesian Voivodeship, Poland

Wojewodzki Specjalistyczny Szpital im. dr. W. Bieganskiego /ID# 131107

Lodz, Łódź Voivodeship, Poland

Centro Hospitalar e Universitario de Coimbra, EPE /ID# 131119

Coimbra, , Portugal

Centro Hospitalar Universitario Lisboa Central, EPE - Hospital dos Capuchos /ID# 131116

Lisbon, , Portugal

Centro Hospitalar Universitário de Lisboa Norte, EPE - Hospital de Santa Maria /ID# 131118

Lisbon, , Portugal

Centro Hospitalar Universitário do Porto, EPE - Hospital Santo António /ID# 131117

Porto, , Portugal

Duplicate_Institutul National de Boli Infectioase Prof. Dr. Matei Bals /ID# 131120

Sector 2, București, Romania

Institutul Clinic Fundeni /ID# 131121

Sector 2, București, Romania

Spitalul Clinic de Boli Infectioase Si Pneumoftiziologie Dr. Victor Babes /Id# 131126

Timișoara, Timiș County, Romania

Institutul Nat. de Boli Infectioase /ID# 131124

Bucharest, , Romania

SC Gastromedica SRL /ID# 131127

Iași, , Romania

Medical Company Hepatolog /ID# 132277

Samara, Samara Oblast, Russia

Republican Clinical Infectious Diseases Hospital n.a. Professor A. F. Agafonov /ID# 132270

Kazan', Tatarstan, Respublika, Russia

South-Ural State Med. Academy /ID# 132274

Chelyabinsk, , Russia

Kuzbass Center for Prevention and Fight agains AIDS /ID# 132269

Kemerovo, , Russia

Krasnoyarsk Regional Center for the Prevention and Control of AIDS /ID# 132278

Krasnoyarsk, , Russia

Moscow Clinical Scientific Center n.a. Loginov /ID# 132266

Moscow, , Russia

Central Clinical Hospital of Russian Academy of Science /ID# 132289

Moscow, , Russia

I. M. Sechenov First Moscow State Medical University /ID# 132275

Moscow, , Russia

City Clinical Hospital #24 /ID# 132268

Moscow, , Russia

Research Institute of Emergency Medicine named after V.I. N.V. Sklifosovsky /ID# 132288

Moscow, , Russia

Clinical Infectious Diseases Hospital #1 /ID# 132272

Novosibirsk, , Russia

Samara State Medical University /ID# 136913

Samara, , Russia

Stavropol State Medical University /ID# 132279

Stavropol, , Russia

Tolyatti City Clinical Hospital #1 /ID# 132273

Tolyatti, , Russia

Multidisciplinary Consultative and Diagnostic Center /ID# 131130

Tyumen, , Russia

Sverdlovsk Regional Clinical Hospital #1 /ID# 132267

Yekaterinburg, , Russia

King Abdulaziz Medical City /ID# 145129

Jeddah, , Saudi Arabia

Ministry Nat Guard Hosp Health /ID# 145126

Riyadh, , Saudi Arabia

King Khalid University Hospita /ID# 132291

Riyadh, , Saudi Arabia

Hospital Universitari Son Espases /ID# 131140

Palma de Mallorca, Balearic Islands, Spain

Hospital Universitario Germans Trias i Pujol /ID# 132293

Badalona, Barcelona, Spain

Hospital Unversitario Marques de Valdecilla /ID# 131141

Santander, Cantabria, Spain

Hospital Donostia /ID# 131144

Donostia / San Sebastian, Guipuzcoa, Spain

Hospital General Universitario Santa Lucia /ID# 131139

Cartagena, Murcia, Spain

Hospital Universitario Central de Asturias /ID# 131138

Oviedo, Principality of Asturias, Spain

OSI Ezkerraldea-Enkarterri-Cruces /ID# 131143

Barakaldo, Vizcaya, Spain

Hospital Universitario A Coruna - CHUAC /ID# 131137

A Coruña, , Spain

Hospital Universitario Reina Sofia /ID# 131135

Córdoba, , Spain

Hospital Universitario de la Princesa /ID# 131131

Madrid, , Spain

Hospital Universitario 12 de Octubre /ID# 131133

Madrid, , Spain

Hospital Universitario La Paz /ID# 131132

Madrid, , Spain

Hospital Universitario Virgen de la Victoria /ID# 131136

Málaga, , Spain

Hospital Universitario Virgen del Rocio /ID# 131134

Seville, , Spain

Hospital Clinico Universitario Lozano Blesa /ID# 132292

Zaragoza, , Spain

Skane University hospital /ID# 131146

Malmo, Skåne County, Sweden

Karolinska University Hospital Solna /ID# 131145

Solna, Stockholm County, Sweden

Sahlgrenska University Hospital /ID# 131147

Gothenburg, Västra Götaland County, Sweden

Kantonsspital St. Gallen /ID# 131148

Sankt Gallen, Canton of St. Gallen, Switzerland

Universitätsspital Zürich /ID# 134881

Zurich, Canton of Zurich, Switzerland

Inselspital, Universitätsspital Bern /ID# 132294

Bern, , Switzerland

Izmir Tepecik Training and Research Hospital /ID# 134968

Konak, İzmir, Turkey (Türkiye)

Hacettepe University Faculty of Medicine /ID# 131150

Ankara, , Turkey (Türkiye)

Ankara Univ Medical Faculty /ID# 131151

Ankara, , Turkey (Türkiye)

Uludag University Medical Faculty /ID# 132297

Bursa, , Turkey (Türkiye)

Istanbul University Istanbul Medical Faculty /ID# 131153

Istanbul, , Turkey (Türkiye)

Ege University Medical Faculty /ID# 132298

Izmir, , Turkey (Türkiye)

Karadeniz University /ID# 131152

Trabzon, , Turkey (Türkiye)

Duplicate_University Hospitals Dorset NHS Foundation Trust /ID# 132306

Poole, Dorset, United Kingdom

University Hospital Southampton NHS Foundation Trust /ID# 131161

Southampton, Hampshire, United Kingdom

Barts Health NHS Trust /ID# 132302

London, London, City of, United Kingdom

The Royal Free London NHS Foundation Trust /ID# 131159

London, London, City of, United Kingdom

Duplicate_Nottingham University Nottingham University Hospitals NHS Trust /ID# 131155

Nottingham, Nottinghamshire, United Kingdom

NHS Greater Glasgow and Clyde /ID# 131162

Glasgow, Scotland, United Kingdom

University Hospitals Birmingham NHS Foundation Trust /ID# 131154

Birmingham, , United Kingdom

Duplicate_NHS Tayside /ID# 132300

Dundee, , United Kingdom

NHS Lothian /ID# 134368

Edinburgh, , United Kingdom

Leeds Teaching Hospitals NHS Trust /ID# 132305

Leeds, , United Kingdom

King's College Hospital NHS Foundation Trusts /ID# 131157

London, , United Kingdom

University Hospital Plymouth NHS Trust /ID# 131160

Plymouth, , United Kingdom

Portsmouth Hospitals University NHS Trust /ID# 131158

Portsmouth, , United Kingdom

Northern Care Alliance NHS Group /ID# 131156

Salford, , United Kingdom

St George's University Hospitals NHS Foundation Trust /ID# 132301

Tooting, , United Kingdom

Countries

Algeria; Australia; Austria; Belgium; Bulgaria; Canada; Denmark; Finland; France; Germany; Greece; Ireland; Israel; Italy; Mexico; Netherlands; Norway; Poland; Portugal; Romania; Russia; Saudi Arabia; Spain; Sweden; Switzerland; Turkey (Türkiye); United Kingdom

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

2014-001022-14

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

M14-423

Identifier Type: -

Identifier Source: org_study_id