Clinical Trials


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)

This study is ongoing, but not recruiting participants.

Information provided by (Responsible Party)
AbbVie Identifier

First received: August 15, 2014
Last updated: March 1, 2018
Last Verified: March 2018
History of Changes


The purpose of this study is to evaluate Long-term outcomes following treatment with ABT-450/r/ABT-267 and ABT-333 with or without RBV in adults with genotype 1 Chronic Hepatitis C Virus (HCV) infection.

Condition Intervention Phase
Chronic Hepatitis C Virus (HCV) Infection Genotype 1

Drug : ABT-333
Drug : ABT-450/r/ABT-267
Drug : Ribavirin (RBV)
Phase 3

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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)

Further study details as provided by AbbVie:

Primary Outcome Measures

  • Incidence of pre-defined clinical outcomes observed during the study [ Time Frame: Up to Post-Treatment week 260 after the subject has taken his/her last dose of study drug. ]
    Measured by all-cause death, liver-related death, liver decompensation, liver transplantation, and hepatocellular carcinoma.
Secondary Outcome Measures:
  • Percentage of subjects with sustained virologic response 12 weeks post-treatment (SVR12) [ Time Frame: 12 weeks after the last actual dose of study drug ]
    Hepatitis C ribonucleic acid less than the lower limit of quantification
  • Change in fibrosis [ Time Frame: Up to Post-Treatment week 260 after the subject has taken his/her last dose of study drug ]
    Measured by change from Day 1 in liver stiffness measured by FibroScan, where available

Enrollment: 1596
Study Start Date: November 5, 2014
Estimated Study Completion Date: October 4, 2021
Estimated Primary Completion Date: October 4, 2021 (Final data collection date for primary outcome measure)

Arms Assigned Interventions
Experimental: ABT-450/r/ABT-267 plus ABT-333 with or without ribavirin (RBV)
ABT-450/r/ABT-267 and ABT-333 coadministered with or without ribavirin (RBV) for 12 or 24 weeks
Drug: ABT-333


Drug: ABT-450/r/ABT-267


Drug: Ribavirin (RBV)




Ages Eligible for Study: 18 Years to 99 Years  
Sexes Eligible for Study: All  
Accepts Healthy Volunteers: No  


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

contacts and locations

Contacts and Locations

Choosing to participate in a study is an important personal decision.Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT02219490


CHU Bab El Oued
Algiers, Algeria, 16000
CHU Bologhine Hospital
Algiers, Algeria, 16000
CHU Mustapha Bacha
Algiers, Algeria, 16000
St. Vincent's Hospital
Darlinghurst, New South Wales, Australia, 2010
Nepean Hospital Kingswood
Kingswood, New South Wales, Australia, 2747
Westmead Hospital
Westmead, New South Wales, Australia, 2145
Greenslopes Private Hospital
Greenslopes, Queensland, Australia, 4120
Royal Brisbane Women's Hosp
Herston, Queensland, Australia, 4029
Royal Adelaide Hospital
Adelaide, South Australia, Australia, 5000
St. Vincents Hosp Melbourne
Fitzroy, Victoria, Australia, 3065
Royal Melbourne Hospital
Parkville, Victoria, Australia, 3050
LKH-Univ. Klinikum Graz
Graz, Austria, 8036
KH der Elisabethinen Linz GmbH
Linz, Austria, 4020
Medical University of Vienna
Vienna, Austria, 1090
CUB Hospital Erasme
Brussels, Bruxelles-Capitale, Belgium, 1070
Cliniques Univ. Saint Luc
Brussels, Belgium, 1200
UZ Leuven
Leuven, Belgium, 3000
Tokuda Hospital Sofia
Sofia, Bulgaria, 1407
Univ Hosp for Active Treat
Sofia, Bulgaria, 1527
Diagnostic Consultative Center
Sofia, Bulgaria, 1612
UMHAT Sv. Ivan Rilski
Sofia, Bulgaria, 1612
Univ Hosp MHAT Sveta Marina
Varna, Bulgaria, 9010
University of Calgary
Calgary, Alberta, Canada, T2N 4Z6
GI Research
Edmonton, Alberta, Canada, T5H 4B9
LAIR Centre
Vancouver, British Columbia, Canada, V5Z 1H2
Vancouver ID Research and Care
Vancouver, British Columbia, Canada, V6Z 2C7
(GIRI) GI Research Institute
Vancouver, British Columbia, Canada, V6Z 2K5
Uni Manitoba
Winnipeg, Manitoba, Canada, R3E 3P4
Saint John Regional Hospital
Saint John, New Brunswick, Canada, E2L 4L2
The Ottawa Hospital
Ottawa, Ontario, Canada, K1H 8L6
Toronto General Hospital
Toronto, Ontario, Canada, M5G 2C4
Toronto Liver Centre
Toronto, Ontario, Canada, M6H 3M1
Toronto Digestive Disease Asso
Vaughan, Ontario, Canada, L4L 4Y7
Clinique Medicale L'Actuel
Montreal, Quebec, Canada, H2L 4P9
McGill Univ HC
Montreal, Quebec, Canada, H3G 1A4
Jewish General Hospital
Montreal, Quebec, Canada, H3T 1E2
Chuq - Chul
Quebec, Canada, G1V 4G2
Aarhus Univ Hospital, Skejby
Aarhus, Denmark, 8200
Copenhagen Univ. Hospital
Hvidovre, Denmark, 2650
Odense Universitets Hospital
Odense, Denmark, 5000
Helsinki Univ Central Hospital
Helsinki, Finland, 00290
Turku University Hospital
Turku, Finland, 20520
Hopital Saint Joseph
Marseille CEDEX 08, Bouches-du-Rhone, France, 13285
Hopital Haut-Lévêque
Pessac CEDEX, Gironde, France, 33604
Hopital Universitaire Purpan - Hopital Pierre-Paul Riquet
Toulouse, Haute-Garonne, France, 31059
CHU Montpellier - Hopital Lapeyronie
Montpellier CEDEX 5, Herault, France, 34295
Jean Verdier Hospital
Bondy, France, 93140
CHU de Grenoble - Albet Michal
Grenoble, France, 38043
CHU Dupuytren
Limoges, France, 87042
Hopital de la Croix Rousse
Lyon, France, 69004
CHU de Nantes, Hotel Dieu -HME
Nantes, France, 44093
CHU de Nice
Nice, France, 06202
Hospital Pontchaillou
Rennes, France, 35033
Nouvel Hopital Civil (NHC)
Strasbourg, France, 67091
Universitatsklinikum Frankfurt
Frankfurt, Hessen, Germany, 60590
Charité Universitätsmedizin Campus Mitte
Berlin, Germany, 10117
Zentr. HIV und Hep.Gast.Ent.
Duesseldorf, Germany, 400237
Universitaetsklinikum Essen
Essen, Germany, 45147
University Hospital Freiburg
Freiburg, Germany, 79106
Univ Klinik Eppendorf Hamburg
Hamburg, Germany, 20246
Med Hochschule Hanover
Hannover, Germany, 30625
Universitaetsklinik Heidelberg
Heidelberg, Germany, 69120
Group Practice Gastroenterolog
Herne, Germany, 44623
Klinikum der Univ Munich
Munich, Germany, 80337
Centr. für Interdiszipl. Med.
Munster, Germany, 48143
Universitatsklinikum Tubingen
Tuebingen, Germany, 72076
General Hospital of Athens "Laiko"
Athens, Attiki, Greece, 115 27
Gen Univ Hosp Alexandroupolis
Alexandroupolis, Greece, 68100
Hippokration General Hospital
Athens, Greece, 115 27
St Vincent's University Hosp
Dublin, Ireland, D04 T6F4
St. James Hospital
Dublin, Ireland, D08 E9P6
Beaumont Hospital
Dublin, Ireland, D09 XR63
Tel Aviv Sourasky Medical Ctr
Tel Aviv-Yafo, Tel-Aviv, Israel, 6423906
Rambam Health Care Campus
Haifa, Israel, 3109601
The Lady Davis Carmel MC
Haifa, Israel, 3436212
Sheba Medical Center
Ramat Gan, Israel, 5262100
A.O. Policlinico S. Orsola Malpighi
Bologna, Emilia-Romagna, Italy, 40138
ASST Grande Ospedale Metropolitano Niguarda
Milano, Lombardia, Italy, 20162
Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico
Milan, Lombardia, Italy, 20122
Azienda Ospedaliera Univ Policlinico "P. Giaccone"
Palermo, Sicilia, Italy, 90127
ASST Papa Giovanni XXIII
Bergamo, Italy, 24127
Azienda Ospedaliero-Universitaria S. Anna di Ferrara
Ferrara, Italy, 44124
A.O. Universitaria Careggi
Florence, Italy, 50139
Ospedali Riuniti Azienda
Foggia, Italy, 71100
A.O.U. Policlinico G. Martino
Messina, Italy, 98125
Ospedale S Giuseppe
Milan, Italy, 20123
Ospedale San Raffaele IRCCS
Milan, Italy, 20132
Azienda Ospedaliera - Polo Uni
Milan, Italy, 20142
Azienda Ospedaliera Luigi Sacc
Milan, Italy, 20157
University of Naples Federico
Naples, Italy, 80131
Azienda Ospedaliero Uni Parma
Parma, Italy, 43100
Policlinico Univ Tor Vergata
Rome, Italy, 00133
AO Univ Policlinico Agostino G
Rome, Italy, 00168
A.O. Uni Giovanni e Ruggi
Salerno, Italy, 84100
IRCCS Casa Sollievo
San Giovanni Rotondo, Italy, 71013
AOU Citta della Salute Scienza
Torino, Italy, 10126
Azienda Sanitaria Universitari
Udine, Italy, 33100
Instituto Technologico y de Es
DEL. Tlalpan, Mexico, 14380
Instituto Metropolitano de Inv
Delegacion Tlalpan, Mexico, 14308
Guadalajara, Mexico, 44160
Mexico City, Mexico, 14050
IBD Clinic
Mexico, Mexico, 14080
Hosp Gen Tijuana & Angeles
Tijuana, Mexico, 22680
Academisch Medisch Centrum
Amsterdam, Noord-Holland, Netherlands, 1105 AZ
Leids Universitair Medisch Cen
Leiden, Netherlands, 2333 ZA
Erasmus Medisch Centrum
Rotterdam, Netherlands, 3015 CE
St. Olavs Hospital
Trondheim, Sor-Trondelag, Norway, 7006
Akershus University Hospital
Lorenskog, Norway, 1478
Stavanger University Hospital
Stavanger, Norway, 4068
Uniwersytecki Szpital Kliniczn
Bialystok, Poland, 15-276
Wojewodzki Szpital Obserwacyjn
Bydgoszcz, Poland, 85-030
Wojewodzki Szpit Bieganskiego
Lodz, Poland, 91-347
Samodzielny Publiczny Szpital
Lublin, Poland, 20-081
ID Clinic
Myslowice, Poland, 41-406
Wojewodzki Szpital Zakazny
Warsaw, Poland, 01-201
Centro Hosp de Lisboa Central
Lisbon, Lisboa, Portugal, 1169-050
Ctr Hosp Univ Coimbra, EPE
Coimbra, Portugal, 3000-075
Centro Hospitalar Lisboa Norte, EPE
Lisboa, Portugal, 1649-035
Centro Hospitalar do Porto EPE
Porto, Portugal, 40990-01
Inst Nat Boli Infect Prof Bals
Bucuresti, Romania, 010825
Inst Nat Boli Infect M Bals
Bucuresti, Romania, 021105
Clinic Fundeni Institute
Bucuresti, Romania, 030463
SC Gastromedica SRL
Lasi, Romania, 700506
Dr. Victor Babes Clinical Hosp
Timisoara, Romania, 300310
Russian Federation
LLC Medical Company Hepatolog
Samara, Samarskaya Oblast, Russian Federation, 443063
State Autonomous Institution
Kazan, Tatarstan, Respublika, Russian Federation, 420140
South-Ural State Med. Academy
Chelyabinsk, Russian Federation, 454052
Sverdlovsk Reg Clin Hosp No. 1
Ekaterinburg, Russian Federation, 620102
Reg Ctr for AIDS
Kemerovo, Russian Federation, 650056
Reg Ctr for AIDS
Krasnoyarsk, Russian Federation, 660049
Moscow Clinical and Diagnostic
Moscow, Russian Federation, 111123
FSBIH Central Clin Hosp RAMS
Moscow, Russian Federation, 117593
Sechonov First Moscow State
Moscow, Russian Federation, 119991
City Clinical Hospital 24
Moscow, Russian Federation, 127015
Res Inst Emrg NV Sklifosovskiy
Moscow, Russian Federation, 129090
Clinical Inf. Dis Hospital 1
Novosibirsk, Russian Federation, 630099
Samara State Medical Universit
Samara, Russian Federation, 443099
Stavropol State Medical Univ
Stavropol, Russian Federation, 355017
Tolya City Clin Hosp
Tolyatti, Russian Federation, 445009
Consulting and Diagnostic Cent
Tyumen, Russian Federation, 625026
Saudi Arabia
King Abdulaziz Medical City
Jeddah, Saudi Arabia, 21423
Ministry Nat Guard Hosp Health
Riyadh, Saudi Arabia, 11426
King Khalid University Hospita
Riyadh, Saudi Arabia, 11472
Comple Hosp Univ de A Coruna
A Coruna, Spain, 15006
Hospital Universitario de Cruc
Barakaldo, Spain, 48903
Hospital Univ Germans Trias I
Barcelona, Spain, 08916
Hospital Gen Univ Santa Lucia
Cartagena, Spain, 30200
Hospital Universitario Reina S
Cordoba, Spain, 14004
Hospital Donostia
Donostia, Spain, 20080
Hospital Univ de la Princesa
Madrid, Spain, 28006
Hosp Univ 12 de Octubre
Madrid, Spain, 28041
Hospital Universitario La Paz
Madrid, Spain, 28046
Hosp Uni Virgen de la Victoria
Malaga, Spain, 29010
Hospital Univ Central Asturias
Oviedo, Spain, 33011
Hospital Univ. Son Espases
Palma de Mallorca, Spain, 07120
Hospital Universitario Marques
Santander, Spain, 39008
Hosp Univ Virgen del Rocio
Sevilla, Spain, 41013
HCU Lozano Blesa
Zaragoza, Spain, 50009
Sahlgrenska University Hosp
Goteborg, Sweden, 413 45
Skanes Universitetssjukhus
Malmö, Sweden, 205 02
Karolinska Univ Sjukhuset
Solna, Sweden, 17176
Kantonsspital St. Gallen
St. Gallen, Sankt Gallen, Switzerland, 9000
Inselspital, Universitaetsklin
Bern, Switzerland, 3010
University Hospital Zurich
Zurich, Switzerland, 8091
Uludağ Üniversitesi Atatürk Rehabilitasyon Uygulama ve Araştırma Merkezi
Osmangazi, Bursa, Turkey, 16080
Hacettepe Univ Med Faculty
Ankara, Turkey, 06230
Ankara Univ Medical Faculty
Ankara, Turkey, 6100
Istanbul University Cerrahpasa Medical Faculty
Istanbul, Turkey, 34098
Ege University Medical Faculty
Izmir, Turkey, 35040
Izmir Tepecik Egitim ve Arasti
Izmir, Turkey, 35170
Karadeniz University
Trabzon, Turkey, 61000
United Kingdom
Univ Hospitals Birmingham NHS
Birmingham, United Kingdom, B15 2TH
The Royal Bournemouth Hospital
Bournemouth, United Kingdom, BH7 7DW
North Manchester General
Crumpsall, United Kingdom, M8 5RB
Ninewells Hospital
Dundee, United Kingdom, DD1 9SY
Western General Hospital
Edinburgh, United Kingdom, EH4 2XU
Gartnavel General Hospital
Glasgow, United Kingdom, G12 0YN
St. James University Hospital
Leeds, United Kingdom, LS9 7TF
The Royal London Hospital
London, United Kingdom, E1 1BB
The Royal Free Hospital
London, United Kingdom, NW3 2QG
King's College Hospital NHS
London, United Kingdom, SE5 9RS
St. George's Healthcare NHS
London, United Kingdom, SW17 0QT
Nottingham University
Nottingham, United Kingdom, NG7 2UH
Derriford Hospital
Plymouth, United Kingdom, PL6 8DH
Queen Alexandra Hospital
Portsmouth, United Kingdom, PO6 3LY
Southampton General Hospital
Southampton, United Kingdom, SO16 6YD

Sponsors and Collaborators



Study Director: AbbVie Inc. AbbVie
More Information

More Information

Responsible Party: AbbVie Identifier: NCT02219490   History of Changes  
Other Study ID Numbers: M14-423  
Study First Received: August 15, 2014  
Last Updated: March 1, 2018  

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  

Keywords provided by AbbVie:

Hepatitis C Genotype 1
Compensated Cirrhosis
Null responder
Non responder

Additional relevant MeSH terms:
Communicable Diseases
Hepatitis A
Hepatitis C
Hepatitis, Chronic
Hepatitis C, Chronic
Ritonavir processed this data on March 16, 2018
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