Clinical Trials

MainTitle

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.
Sponsor
AbbVie


Information provided by (Responsible Party)
AbbVie
ClinicalTrials.gov Identifier
NCT02219490

First received: August 15, 2014
Last updated: November 1, 2017
Last Verified: November 2017
History of Changes
Purpose

Purpose

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-450/r/ABT-267
Drug : ABT-333
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:
  • 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
  • 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

Estimated Enrollment: 1650
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-450/r/ABT-267

tablet

Drug: ABT-333

tablet

Drug: Ribavirin (RBV)

tablet

Eligibility

Eligibility

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

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

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 ClinicalTrials.gov identifier: NCT02219490

Locations

Algeria
CHU Bab El Oued /ID# 145420
Algiers, Algeria, 16000
CHU Bologhine Hospital /ID# 145421
Algiers, Algeria, 16000
CHU Mustapha Bacha /ID# 132130
Algiers, Algeria, 16000
Australia
Royal Adelaide Hospital /ID# 131002
Adelaide, Australia, 5000
Royal Brisbane and Womens Hospital /ID# 131004
Brisbane, Australia, 4029
St. Vincent's Hospital /ID# 131001
Darlinghurst, Australia, 2010
St. Vincents Hospital Melbourne /ID# 131000
Fitzroy, Australia, 3065
Greenslopes Private Hospital /ID# 131003
Greenslopes, Australia, 4120
Nepean Hospital Kingswood /ID# 130999
Kingswood, Australia, 2747
Royal Melbourne Hospital /ID# 130998
Parkville, Australia, 3050
Westmead Hospital /ID# 130997
Westmead, Australia, 2145
Austria
Landeskrankenhaus Universitaetsklinikum Graz /ID# 131018
Graz, Austria, 8036
Ordensklinikum Linz GmbH Elisabethinen /ID# 131017
Linz, Austria, 4020
Medical University of Vienna /ID# 131015
Vienna, Austria, 1090
Belgium
CUB Hospital Erasme /ID# 131020
Brussels, Belgium, 1070
Cliniques Universitaires Saint-Luc /ID# 131019
Brussels, Belgium, 1200
Universitair Ziekenhuis Leuven /ID# 131021
Leuven, Belgium, 3000
Bulgaria
Tokuda Hospital Sofia /ID# 131022
Sofia, Bulgaria, 1407
University Multiprofile Hospital for Active Treatment' /ID# 131026
Sofia, Bulgaria, 1431
Diagnostic Consultative Center /ID# 131027
Sofia, Bulgaria, 1463
University Hospital Tsaritsa Yoanna /ID# 131023
Sofia, Bulgaria, 1527
Univ Hospital MHAT Sveta Marina Varna EAD /ID# 131025
Varna, Bulgaria, 9010
Canada
University of Calgary /ID# 134370
Calgary, Canada, T2N 4Z6
GI Research /ID# 132169
Edmonton, Canada, T5H 4B9
Clinique Medicale L'Actuel /ID# 132167
Montreal, Canada, H2I 4P9
Jewish General Hospital, Sir Mortimer B. Davis /ID# 132165
Montreal, Canada, H3T 1E2
McGill University Health Centre /ID# 132166
Montreal, Canada, H4A 3J1
The Ottawa Hospital Cancer Centre /ID# 132170
Ottawa, Canada, K1H 8L6
CHUQ - Centre Hospitalier de l'Universite Laval /ID# 132132
Quebec, Canada, G1V 4G2
Saint John Regional Hospital /ID# 131210
Saint John, Canada, E2L 4L2
Toronto General Hospital - University Health Network /ID# 132134
Toronto, Canada, M5G 2C4
Toronto Liver Centre /ID# 132168
Toronto, Canada, M6H 3M1
LAIR Centre /ID# 130970
Vancouver, Canada, V5Z 1H2
Vancouver Infectious Diseases Centre /ID# 134369
Vancouver, Canada, V6Z 2C7
GIRI Gastrointestinal Research Institute /ID# 132171
Vancouver, Canada, V6Z-2K5
Toronto Digestive Disease Associates /ID# 130968
Vaughan, Canada, L4L 4Y7
University of Manitoba /ID# 130969
Winnipeg, Canada, R3E 3P4
Denmark
Aarhus University Hospital, Skejby /ID# 131030
Aarhus N, Denmark, 8200
Copenhagen University Hospital, Hvidovre /ID# 131031
Hvidovre, Denmark, DK 2650
Odense Universitets Hospital Svendborg Sygehus /ID# 131029
Odense C, Denmark, 5000
Finland
Helsinki University Central Hospital /ID# 131034
Helsinki, Finland, 00290
Turku University Hospital /ID# 131032
Turku, Finland, 20520
France
Jean Verdier Hospital /ID# 135877
Bondy Cedex, France, 93140
CHU de Grenoble - Hopital Albert Michallon /ID# 131041
Grenoble Cedex 9, France, 38043
CHU Dupuytren /ID# 131038
Limoges, France, 87042
Hopital de la Croix Rousse /ID# 131042
Lyon cedex 04, France, 69317
Hopital Saint Joseph /ID# 132177
Marseilles, France, 13285
Hopital Saint Eloi /ID# 131037
Montpellier Cedex 5, France, 34295
CHU Hotel Dieu /ID# 132179
Nantes, Cedex 1, France, 44093
CHU de Nice /ID# 131040
Nice, France, 06202
Hopital du Haut Leveque /ID# 131036
Pessac Cedex, France, 33604
Hospital de Pontchaillou- CHU Rennes /ID# 132173
Rennes, France, 35033
Nouvel Hopital Civil (NHC) /ID# 132174
Strasbourg, France, 67091
Hopital Universitaire Purpan /ID# 131035
Toulouse, France, 31000
Germany
Charite Universitaetsmedizin Berlin /ID# 131053
Berlin, Germany, 13353
Zentrum für HIV und Hepatogastroenterologie /ID# 131052
Duesseldorf, Germany, 400237
Universitaetsklinikum Essen /ID# 131048
Essen, Germany, 45147
Universitaetsklinikum Frankfurt /ID# 131055
Frankfurt, Germany, 60590
University Hospital Freiburg /ID# 131044
Freiburg, Germany, 79106
Universitaetsklinikum Eppendorf Hamburg-CeDeF /ID# 131051
Hamburg, Germany, 20246
Medizinische Hochschule Hanover /ID# 131054
Hanover, Germany, 30625
Universitaetsklinikum Heidelberg Hautklinik /ID# 134371
Heidelberg, Germany, 69120
Group Practice Gastroenterology /ID# 131050
Herne, Germany, 44623
CIM-Centrum fuer Interdisziplinaere Medizin GmbH /ID# 131046
Muenster, Germany, 48143
Ludwig Maximiliam Universitaet Muenchen /ID# 131049
Munich, Germany, 81377
Universitatsklinikum Tubingen /ID# 131045
Tuebingen, Germany, 72076
Greece
General University Hospital of Alexandroupolis /ID# 131056
Alexandroupolis, Greece, 68100
Hippokration General Hospital of Athens /ID# 131057
Athens, Greece, 115 27
General Hospital of Athens "Laiko" /ID# 131088
Athens, Greece, 11527
Ireland
St Vincent's University Hospital /ID# 132181
Dublin 4, Ireland, D04
St. James Hospital /ID# 132180
Dublin 8, Ireland
Beaumont Hospital /ID# 131089
Dublin 9, Ireland, D09
Israel
Rambam Health Care Campus /ID# 131090
Haifa, Israel, 31096
The Lady Davis Carmel Medical Center /ID# 131091
Haifa, Israel, 3436212
Tel Aviv Sourasky Medical Center /ID# 132182
Tel Aviv, Israel, 64239
The Chaim Sheba Medical Center /ID# 131092
Tel Hashomer, Israel, 52621
Italy
Azienda Ospedaliera Papa Giovanni XXIII /ID# 132188
Bergamo, Italy, 24127
AO Universitaria Bologna, Policlinico S. Orsola Malpighi /ID# 131095
Bologna, Italy, 40138
Azienda Ospedaliera Universitaria Careggi /ID# 132197
Florence, Italy, 50134
Ospedali Riuniti Azienda Ospedaliero Universitaria /ID# 132195
Foggia, Italy, 71122
A.O.U. Policlinico G. Martino Messina /ID# 132193
Messina, Italy, 98124
Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico /ID# 131097
Milan, Italy, 20122
Ospedale S Giuseppe Multimedica /ID# 132194
Milan, Italy, 20123
Fondazione Centro San Raffaele del Monte Tabor /ID# 131093
Milan, Italy, 20127
Azienda Ospedaliera - Polo Universitario San Paolo /ID# 132198
Milan, Italy, 20142
Azienda Ospedaliera Luigi Sacco /ID# 134372
Milan, Italy, 20157
ASST Grande Ospedale Metropolitano Niguarda /ID# 131104
Milan, Italy, 20162
A.O.U. Policlinico di Modena /ID# 131102
Modena, Italy, 41124
Azienda Ospedaliera Universita degli studi Federico II /ID# 131096
Naples, Italy, 80131
University of Naples Federico II /ID# 132191
Naples, Italy, 80138
Azienda Ospedaliera Universitaria Policlinico P. Giaccone /ID# 132184
Palermo, Italy, 90129
Azienda Ospedaliero Universitaria di Parma /ID# 132183
Parma, Italy, 43126
Fondazione PTV Policlinico Tor Vergata di Roma /ID# 132185
Rome, Italy, 00133
A.O. Universitaria Policlinico Agostino Gemelli /ID# 131098
Rome, Italy, 00168
A.O. Universitaria S. Giovanni e Ruggi d'Aragona /ID# 132192
Salerno, Italy, 84126
IRCCS Casa Sollievo della Sofferenza /ID# 132190
San Giovanni Rotondo, Italy, 71013
A.O.U. Citta della Salute e della Scienza di Turin /ID# 131100
Turin, Italy, 10126
Azienda Sanitaria Universitaria Integrata di Udine /ID# 132196
Udine, Italy, 33100
Mexico
Instituto Technologico y de Estudios Superiores /ID# 132383
Del. Tlalpan, Mexico, 14380
Instituto Metropolitano de Investigacion Clinica S.C. /ID# 132201
Delegacion Tlalpan, Mexico, 14370
CIF-BIOTEC/Medica Sur, S.A.B. de C.V. /ID# 134971
Distrito Federal, Mexico, CP 14050
Cife /Id# 130974
Guadalajara Jalisco, Mexico, 44160
Instituto Nacional de Ciencias Medicas y Nutricion /ID# 130975
Mexico City, Tlalpan, Mexico, CP 14000
Hospital General Tijuana and Hospital Angeles Tijuana /ID# 130972
Tijuana, Mexico, 22320
Netherlands
Academisch Medisch Centrum /ID# 132205
Amsterdam, Netherlands, 1105 AZ
Leids Universitair Medisch Centrum /ID# 132204
Leiden, Netherlands, 2333 ZA
Erasmus Medisch Centrum /ID# 132206
Rotterdam, Netherlands, 3015 CE
Norway
Akershus University Hospital /ID# 132212
Lorenskog, Oslo, Norway, N-1474
Stavanger University Hospital /ID# 132211
Stavanger, Norway, 4011
St. Olavs Hospital /ID# 132213
Trondheim, Norway, 7030
Poland
Uniwersytecki Szpital Kliniczny w Bialymstoku /ID# 131108
Bialystok, Poland, 15-540
Wojewodzki Szpital Obserwacyjno-Zakazny im. T. Browicza /ID# 131106
Bydgoszcz, Poland, 85-030
Wojewodzki Specjalistyczny Szpital im Dr Wl. Bieganskiego /ID# 131107
Lodz, Poland, 91-347
Samodzielny Publiczny Szpital Kliniczny nr 1 w Lublin /ID# 131115
Lublin, Poland, 20-081
ID Clinic /ID# 131111
Myslowice, Poland, 41-400
Wojewodzki Szpital Zakazny /ID# 131112
Warsaw, Poland, 01-201
Portugal
Centro Hospitalar e Universitario de Coimbra, EPE /ID# 131119
Coimbra, Portugal, 3000-075
Hospital Santo Antonio dos Capuchos /ID# 131116
Lisbon, Portugal, 1169-050
Hospital de Santa Maria /ID# 131118
Lisbon, Portugal, 1649-035
Centro Hospitalar do Porto EPE- Hospital Santo Antonio /ID# 131117
Porto, Portugal, 4050-345
Romania
Institutul National de Boli Infectioase Prof. Dr. Matei Bals /ID# 131120
Bucharest, Romania, 021105
Institutul National de Boli Infectioase Prof. Matei Bals /ID# 131124
Bucharest, Romania, 021105
Clinic Fundeni Institute /Id# 131121
Bucharest, Romania, 022328
SC Gastromedica SRL /ID# 131127
Iasi, Romania, 700089
"Dr. Victor Babes" Clinical Hospital of Pneumophthisiology /ID# 131126
Timisoara, Romania, 300310
Russian Federation
South-Ural State Med. Academy /ID# 132274
Chelyabinsk, Russian Federation, 454052
Sverdlovsk Region Clinical Hospital No. 1 /ID# 132267
Ekaterinburg, Russian Federation, 620102
Republican Clinical Hospital for Infectious Diseases /ID# 132270
Kazan, Russian Federation, 420140
Kemerovo Regional Ctr for Disease Prevention-Control of AIDS /ID# 132269
Kemerovo, Russian Federation, 650056
KGUZ Regional Centre for Disease Prevention-Control of AIDS /ID# 132278
Krasnoyarsk, Russian Federation, 660049
Moscow Clinical Research and Practice Centre /ID# 132266
Moscow, Russian Federation, 111123
FSBIH Central Clinical Hospital of RAMS /ID# 132289
Moscow, Russian Federation, 117593
Sechonov First Moscow State Medical University /ID# 132275
Moscow, Russian Federation, 119021
City Clinical Hospital 24 /ID# 132268
Moscow, Russian Federation, 127015
Research Institute For Emergency Medicine Named After NV Skl /ID# 132288
Moscow, Russian Federation, 129090
Clinical Infectious Diseases Hospital #1 /ID# 132272
Novosibirsk, Russian Federation, 630099
LLC Medical Company /ID# 132277
Samara, Russian Federation, 443063
Samara State Medical University /ID# 136913
Samara, Russian Federation, 443079
Stavropol State Medical University /ID# 132279
Stavropol, Russian Federation, 355017
Tolyatti City Clinical Hospital #1 /ID# 132273
Tolyatti, Russian Federation, 445009
Consultative Diagnostic Centre Tyumen /ID# 131130
Tyumen, Russian Federation, 625026
Saudi Arabia
King Abdulaziz Medical City National Guard Health Affairs /ID# 145129
Jeddah, Saudi Arabia, 21423
Ministry of National Guard Hospital Health Affairs /ID# 145126
Riyadh, Saudi Arabia, 11426
King Khalid University Hospital /ID# 132291
Riyadh, Saudi Arabia, 11472
Spain
Hospital Universitario de Cruces /ID# 131143
Barakaldo, Spain, 48903
Hospital Universitari Germans Trias I Pujol /ID# 132293
Barcelona, Spain, 08916
Hospital General Universitario Santa Lucia /ID# 131139
Cartagena, Spain, 30202
Hospital Universitario Reina Sofia /ID# 131135
Cordoba, Spain, 14004
Complejo Hospitalario Universitario de A Coruna /ID# 131137
Coruna, Spain, 15006
Hospital Universitario La Princesa /ID# 131131
Madrid, Spain, 28006
Hospital Universitario 12 de Octubre /ID# 131133
Madrid, Spain, 28041
Hospital Universitario La Paz /ID# 131132
Madrid, Spain, 28046
Hospital Universitario Virgen de la Victoria /ID# 131136
Malaga, Spain, 29010
Hospital Universitario Central de Asturias /ID# 131138
Oviedo, Spain, 33011
Hospital Universitari Son Espases /ID# 131140
Palma de Mallorca, Islas Balea, Spain, 07120
Hospital Donostia /ID# 131144
San Sebastian, Spain, 20014
Hospital Universitario Marques de Valdecilla /ID# 131141
Santander, Cantabria, Spain, 39008
Hospital Universitario Virgen del Rocio /ID# 131134
Sevilla, Spain, 41013
Hospital Clinico Universitario Lozano Blesa /ID# 132292
Zaragoza, Spain, 50009
Sweden
Sahlgrenska University Hospital /ID# 131147
Gothenburg, Sweden, 416 85
Skanes Universitetssjukhus /ID# 131146
Malmo, Sweden, SE-205 02
Karolinska University Hospital /ID# 131145
Stockholm, Sweden, SE 141 86
Switzerland
Inselspital Bern /ID# 132294
Bern, Switzerland, 3010
Kantonsspital St. Gallen /ID# 131148
St. Gallen, Switzerland, 9007
University Hospital Zurich /ID# 134881
Zurich, Switzerland, 8091
Turkey
Ankara University Medical Faculty /ID# 131151
Ankara, Turkey, 06100
Hacettepe University Medical Faculty /ID# 131150
Ankara, Turkey, 06100
Ege University Medical Faculty /ID# 132298
Bornova, Izmir, Turkey, 35100
Uludag University Medical Faculty /ID# 132297
Gorukle, Bursa, Turkey, 16059
University of Istanbul Cerrahpasa Faculty of Medicine /ID# 131153
Istanbul, Turkey, 34098
Izmir Tepecik Egitim ve Arastirma Hastanesi /ID# 134968
Izmir, Turkey, 35170
Karadeniz University /ID# 131152
Trabzon, Turkey, 61080
United Kingdom
University Hospitals Birmingham NHS /ID# 131154
Birmingham, Edgbaston, United Kingdom, B15 2TH
The Royal Bournemouth Hospital /ID# 132306
Bournemouth, United Kingdom, BH7 7DW
Ninewells Hospital /ID# 132300
Dundee, United Kingdom, DD1 9SY
Western General Hospital /ID# 134368
Edinburghy, United Kingdom, EH4 2XU
Gartnavel General Hospital /ID# 131162
Glasgow, United Kingdom, G12 0YN
St. James University Hospital /ID# 132305
Leeds, Yorkshire, United Kingdom, LS18 5RN
The Royal London Hospital /ID# 132302
London, United Kingdom, E1 1BB
The Royal Free Hospital /ID# 131159
London, United Kingdom, NM3 2QG
King College Hospital, King's College Hospital NHS Foundatio /ID# 131157
London, United Kingdom, SE5 9RS
St. George's Healthcare NHS Trust /ID# 132301
London, United Kingdom, SW17 0QT
North Manchester General Hospital /ID# 131156
Manchester, United Kingdom, M8 5RB
Nottingham University Hospitals NHS Trust /ID# 131155
Nottingham, United Kingdom, NG7 2UH
Derriford Hospital /ID# 131160
Plymouth, United Kingdom, PL6 8DH
Queen Alexandra Hospital /ID# 131158
Portsmouth, United Kingdom, P06 3LY
Southampton General Hospital NHS Foundation Trust /ID# 131161
Southampton, United Kingdom, SO16 6YD

Sponsors and Collaborators

AbbVie

Investigators

Study Director: Mariem Charafeddine, PhD AbbVie
More Information

More Information


Responsible Party: AbbVie  
ClinicalTrials.gov Identifier: NCT02219490   History of Changes  
Other Study ID Numbers: M14-423  
  2014-001022-14  
Study First Received: August 15, 2014  
Last Updated: November 1, 2017  

Keywords provided by AbbVie:

Non responder
Null responder
Treatment-Experienced
Cirrhosis
Relapser
Hepatitis C Genotype 1
Compensated Cirrhosis
Naive

Additional relevant MeSH terms:
Infection
Communicable Diseases
Hepatitis
Hepatitis A
Hepatitis C
Hepatitis, Chronic
Hepatitis C, Chronic
Ribavirin
Ritonavir

ClinicalTrials.gov processed this data on December 15, 2017
This information is provided by ClinicalTrials.gov.