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: May 31, 2018
Last Verified: May 2018
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-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: October 30, 2014
Estimated Study Completion Date: May 13, 2021
Estimated Primary Completion Date: May 13, 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

tablet

Drug: ABT-450/r/ABT-267

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
St. Vincent's Hospital, Darlinghurst /ID# 131001
Darlinghurst, New South Wales, Australia, 2010
Nepean Hospital Kingswood /ID# 130999
Kingswood, New South Wales, Australia, 2747
Westmead Hospital /ID# 130997
Westmead, New South Wales, Australia, 2145
Greenslopes Private Hospital /ID# 131003
Greenslopes, Queensland, Australia, 4120
Royal Brisbane and Women's Hospital /ID# 131004
Herston, Queensland, Australia, 4029
Royal Adelaide Hospital /ID# 131002
Adelaide, South Australia, Australia, 5000
St. Vincents Hosp Melbourne /ID# 131000
Fitzroy, Victoria, Australia, 3065
Royal Melbourne Hospital /ID# 130998
Parkville, Victoria, Australia, 3050
Austria
AKH Wien /ID# 131015
Vienna, Wien, Austria, 1090
LKH-Univ. Klinikum Graz /ID# 131018
Graz, Austria, 8036
KH der Elisabethinen Linz GmbH /ID# 131017
Linz, Austria, 4020
Belgium
CUB Hospital Erasme /ID# 131020
Brussels, Bruxelles-Capitale, Belgium, 1070
Cliniques Universitaires Saint Luc /ID# 131019
Woluwe-Saint-Lambert, Bruxelles-Capitale, Belgium, 1200
UZ Leuven /ID# 131021
Leuven, Belgium, 3000
Bulgaria
Tokuda Hospital Sofia /ID# 131022
Sofia, Bulgaria, 1407
Univ Hosp for Active Treat /ID# 131023
Sofia, Bulgaria, 1527
Diagnostic Consultative Center /ID# 131027
Sofia, Bulgaria, 1612
UMHAT Sv. Ivan Rilski /ID# 131026
Sofia, Bulgaria, 1612
Univ Hosp MHAT Sveta Marina /ID# 131025
Varna, Bulgaria, 9010
Canada
University of Calgary /ID# 134370
Calgary, Alberta, Canada, T2N 4Z6
GI Research /ID# 132169
Edmonton, Alberta, Canada, T5H 4B9
LAIR Centre /ID# 130970
Vancouver, British Columbia, Canada, V5Z 1H2
Vancouver ID Research and Care /ID# 134369
Vancouver, British Columbia, Canada, V6Z 2C7
GIRI Gastrointestinal Research Institute /ID# 132171
Vancouver, British Columbia, Canada, V6Z 2K5
Uni Manitoba /ID# 130969
Winnipeg, Manitoba, Canada, R3E 3P4
Saint John Regional Hospital /ID# 131210
Saint John, New Brunswick, Canada, E2L 4L2
The Ottawa Hospital /ID# 132170
Ottawa, Ontario, Canada, K1H 8L6
Toronto General Hospital /ID# 132134
Toronto, Ontario, Canada, M5G 2C4
Toronto Liver Centre /ID# 132168
Toronto, Ontario, Canada, M6H 3M1
Toronto Digestive Disease Asso /ID# 130968
Vaughan, Ontario, Canada, L4L 4Y7
Clinique Medicale L'Actuel /ID# 132167
Montreal, Quebec, Canada, H2L 4P9
McGill Univ HC /ID# 132166
Montreal, Quebec, Canada, H3G 1A4
Jewish General Hospital /ID# 132165
Montreal, Quebec, Canada, H3T 1E2
Chuq - Chul /Id# 132132
Quebec, Canada, G1V 4G2
Denmark
Odense Universitets Hospital /ID# 131029
Odense C, Syddanmark, Denmark, 5000
Aarhus Univ Hospital, Skejby /ID# 131030
Aarhus, Denmark, 8200
Copenhagen Univ. Hospital /ID# 131031
Hvidovre, Denmark, 2650
Finland
Helsinki Univ Central Hospital /ID# 131034
Helsinki, Finland, 00290
Turku University Hospital /ID# 131032
Turku, Finland, 20520
France
Hopital Saint Joseph /ID# 132177
Marseille CEDEX 08, Bouches-du-Rhone, France, 13285
CHU Dupuytren /ID# 131038
Limoges CEDEX 1, Franche-Comte, France, 87042
Hopital Haut-Lévêque /ID# 131036
Pessac CEDEX, Gironde, France, 33604
Hopital Universitaire Purpan /ID# 131035
Toulouse, Haute-Garonne, France, 31059
Hopital Saint Eloi /ID# 131037
Montpellier CEDEX 5, Herault, France, 34295
Jean Verdier Hospital /ID# 135877
Bondy, France, 93140
CHU de Grenoble - Albet Michal /ID# 131041
Grenoble, France, 38043
Hopital de la Croix Rousse /ID# 131042
Lyon, France, 69004
CHU de Nantes, Hotel Dieu -HME /ID# 132179
Nantes, France, 44093
CHU de Nice /ID# 131040
Nice, France, 06202
Hospital Pontchaillou /ID# 132173
Rennes, France, 35033
Nouvel Hopital Civil (NHC) /ID# 132174
Strasbourg, France, 67091
Germany
Universitaetsklinik Heidelberg /ID# 134371
Heidelberg, Baden-Wuerttemberg, Germany, 69120
Universitatsklinikum Frankfurt /ID# 131055
Frankfurt, Hessen, Germany, 60590
Zentr. HIV und Hep.Gast.Ent. /ID# 131052
Düsseldorf, Nordrhein-Westfalen, Germany, 40237
Charité Universitätsmedizin Campus Mitte /ID# 131053
Berlin, Germany, 10117
Universitaetsklinikum Essen /ID# 131048
Essen, Germany, 45147
University Hospital Freiburg /ID# 131044
Freiburg, Germany, 79106
Univ Klinik Eppendorf Hamburg /ID# 131051
Hamburg, Germany, 20246
Med Hochschule Hanover /ID# 131054
Hannover, Germany, 30625
Group Practice Gastroenterolog /ID# 131050
Herne, Germany, 44623
Klinikum der Univ Munich /ID# 131049
Munich, Germany, 80337
Centr. für Interdiszipl. Med. /ID# 131046
Munster, Germany, 48143
Universitatsklinikum Tubingen /ID# 131045
Tuebingen, Germany, 72076
Greece
General Hospital of Athens Laiko /ID# 131088
Athens, Attiki, Greece, 115 27
Gen Univ Hosp Alexandroupolis /ID# 131056
Alexandroupolis, Greece, 68100
Hippokration General Hospital /ID# 131057
Athens, Greece, 115 27
Ireland
St. James's Hospital /ID# 132180
Dublin 8, Dublin, Ireland, D08 E9P6
St Vincent's University Hosp /ID# 132181
Dublin, Ireland, D04 T6F4
Beaumont Hospital /ID# 131089
Dublin, Ireland, D09 XR63
Israel
Tel Aviv Sourasky Medical Ctr /ID# 132182
Tel Aviv-Yafo, Tel-Aviv, Israel, 6423906
Rambam Health Care Campus /ID# 131090
Haifa, Israel, 3109601
The Lady Davis Carmel MC /ID# 131091
Haifa, Israel, 3436212
Sheba Medical Center /ID# 131092
Ramat Gan, Israel, 5262100
Italy
A.O.U. Policlinico S.Orsola-Malpighi /ID# 131095
Bologna, Emilia-Romagna, Italy, 40138
AO Univ Policlinico Agostino G /ID# 131098
Rome, Lazio, Italy, 00168
ASST Grande Ospedale Metropolitano Niguarda /ID# 131104
Milano, Lombardia, Italy, 20162
Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico /ID# 131097
Milan, Lombardia, Italy, 20122
AOU Citta della Salute Scienza /ID# 131100
Turin, Piemonte, Italy, 10126
Policlinico Paolo Giaccone /Id# 132184
Palermo, Sicilia, Italy, 90127
ASST Papa Giovanni XXIII /ID# 132188
Bergamo, Italy, 24127
A.O.U Sant'Anna di Ferrara /ID# 131102
Ferrara, Italy, 44124
A.O. Universitaria Careggi /ID# 132197
Florence, Italy, 50139
Ospedali Riuniti Azienda /ID# 132195
Foggia, Italy, 71100
A.O.U. Policlinico G. Martino /ID# 132193
Messina, Italy, 98125
Ospedale S Giuseppe /ID# 132194
Milan, Italy, 20123
Ospedale San Raffaele IRCCS /ID# 131093
Milan, Italy, 20132
Azienda Ospedaliera - Polo Uni /ID# 132198
Milan, Italy, 20142
Azienda Ospedaliera Luigi Sacc /ID# 134372
Milan, Italy, 20157
University of Naples Federico /ID# 131096
Naples, Italy, 80131
University of Naples Federico /ID# 132191
Naples, Italy, 80131
Azienda Ospedaliero Uni Parma /ID# 132183
Parma, Italy, 43100
Policlinico Univ Tor Vergata /ID# 132185
Rome, Italy, 00133
A.O. Uni Giovanni e Ruggi /ID# 132192
Salerno, Italy, 84100
IRCCS Casa Sollievo /ID# 132190
San Giovanni Rotondo, Italy, 71013
Azienda Sanitaria Universitari /ID# 132196
Udine, Italy, 33100
Mexico
Instituto Technologico y de Es /ID# 132383
DEL. Tlalpan, Mexico, 14380
Instituto Metropolitano de Inv /ID# 132201
Delegacion Tlalpan, Mexico, 14308
Cife /Id# 130974
Guadalajara, Mexico, 44160
CIF-BIOTEC/Medica Sur /ID# 134971
Mexico City, Mexico, 14050
IBD Clinic /ID# 130975
Mexico, Mexico, 14080
Hosp Gen Tijuana & Angeles /ID# 130972
Tijuana, Mexico, 22680
Netherlands
Academisch Medisch Centrum /ID# 132205
Amsterdam, Noord-Holland, Netherlands, 1105 AZ
Leids Universitair Medisch Cen /ID# 132204
Leiden, Netherlands, 2333 ZA
Erasmus Medisch Centrum /ID# 132206
Rotterdam, Netherlands, 3015 CE
Norway
Akershus Universitetssykehus_MAIN /ID# 132212
Lorenskog, Akershus, Norway, 1478
St. Olavs Hospital /ID# 132213
Trondheim, Sor-Trondelag, Norway, 7006
Stavanger University Hospital /ID# 132211
Stavanger, Norway, 4068
Poland
Uniwersytecki Szpital Kliniczn /ID# 131108
Bialystok, Poland, 15-276
Wojewodzki Szpital Obserwacyjn /ID# 131106
Bydgoszcz, Poland, 85-030
Wojewodzki Szpit Bieganskiego /ID# 131107
Lodz, Poland, 91-347
Samodzielny Publiczny Szpital /ID# 131115
Lublin, Poland, 20-081
ID Clinic /ID# 131111
Myslowice, Poland, 41-406
Wojewodzki Szpital Zakazny /ID# 131112
Warsaw, Poland, 01-201
Portugal
Centro Hosp de Lisboa Central /ID# 131116
Lisbon, Lisboa, Portugal, 1169-050
Ctr Hosp Univ Coimbra, EPE /ID# 131119
Coimbra, Portugal, 3000-075
Centro Hospitalar Lisboa Norte, EPE /ID# 131118
Lisboa, Portugal, 1649-035
Centro Hospitalar do Porto EPE /ID# 131117
Porto, Portugal, 4099-001
Romania
Clinic Fundeni Institute /ID# 131121
Bucharest, Bucuresti, Romania, 022328
Institutul Nat. de Boli Infectioase /ID# 131124
Bucuresti, Romania, 010825
Inst Nat Boli Infect M Bals /ID# 131120
Bucuresti, Romania, 021105
SC Gastromedica SRL /ID# 131127
Lasi, Romania, 700506
Dr. Victor Babes Clinical Hosp /ID# 131126
Timisoara, Romania, 300310
Russian Federation
LLC Medical Company Hepatolog /ID# 132277
Samara, Samarskaya Oblast, Russian Federation, 443063
State Autonomous Institution /ID# 132270
Kazan, Tatarstan, Respublika, Russian Federation, 420140
South-Ural State Med. Academy /ID# 132274
Chelyabinsk, Russian Federation, 454052
Sverdlovsk Reg Clin Hosp No. 1 /ID# 132267
Ekaterinburg, Russian Federation, 620102
Reg Ctr for AIDS /ID# 132269
Kemerovo, Russian Federation, 650056
Reg Ctr for AIDS /ID# 132278
Krasnoyarsk, Russian Federation, 660049
Moscow Clinical and Diagnostic /ID# 132266
Moscow, Russian Federation, 111123
FSBIH Central Clin Hosp RAMS /ID# 132289
Moscow, Russian Federation, 117593
Sechonov First Moscow State /ID# 132275
Moscow, Russian Federation, 119991
City Clinical Hospital 24 /ID# 132268
Moscow, Russian Federation, 127015
Res Inst Emrg NV Sklifosovskiy /ID# 132288
Moscow, Russian Federation, 129090
Clinical Inf. Dis Hospital 1 /ID# 132272
Novosibirsk, Russian Federation, 630099
Samara State Medical Universit /ID# 136913
Samara, Russian Federation, 443099
Stavropol State Medical Univ /ID# 132279
Stavropol, Russian Federation, 355017
Tolya City Clin Hosp /ID# 132273
Tolyatti, Russian Federation, 445009
Consulting and Diagnostic Cent /ID# 131130
Tyumen, Russian Federation, 625026
Saudi Arabia
King Abdulaziz Medical City /ID# 145129
Jeddah, Saudi Arabia, 21423
Ministry Nat Guard Hosp Health /ID# 145126
Riyadh, Saudi Arabia, 11426
King Khalid University Hospita /ID# 132291
Riyadh, Saudi Arabia, 11472
Spain
H. Un. Marques de Valdecilla /ID# 131141
Santander, Cantabria, Spain, 39008
Comple Hosp Univ de A Coruna /ID# 131137
A Coruna, Spain, 15006
OSI Ezkerraldea-Enkarterri-Cruces /ID# 131143
Barakaldo, Spain, 48903
Hospital Univ Germans Trias I /ID# 132293
Barcelona, Spain, 08916
Hospital Gen Univ Santa Lucia /ID# 131139
Cartagena, Spain, 30200
Hospital Universitario Reina S /ID# 131135
Cordoba, Spain, 14004
Hospital Donostia /ID# 131144
Donostia, Spain, 20080
Hospital Univ de la Princesa /ID# 131131
Madrid, Spain, 28006
Hosp Univ 12 de Octubre /ID# 131133
Madrid, Spain, 28041
Hospital Universitario La Paz /ID# 131132
Madrid, Spain, 28046
Hosp Uni Virgen de la Victoria /ID# 131136
Malaga, Spain, 29010
Hospital Univ Central Asturias /ID# 131138
Oviedo, Spain, 33011
Hospital Univ. Son Espases /ID# 131140
Palma de Mallorca, Spain, 07120
Hosp Univ Virgen del Rocio /ID# 131134
Sevilla, Spain, 41013
HCU Lozano Blesa /ID# 132292
Zaragoza, Spain, 50009
Sweden
Skanes Universitetssjukhus /ID# 131146
Malmö, Skane Lan, Sweden, 214 28
Sahlgrenska University Hosp /ID# 131147
Goteborg, Sweden, 413 45
Karolinska Univ Sjukhuset /ID# 131145
Solna, Sweden, 17176
Switzerland
Kantonsspital St. Gallen /ID# 131148
St. Gallen, Sankt Gallen, Switzerland, 9007
Inselspital, Universitaetsklin /ID# 132294
Bern, Switzerland, 3010
University Hospital Zurich /ID# 134881
Zurich, Switzerland, 8091
Turkey
Izmir Tepecik Egitim ve Arastirma Hastanesi /ID# 134968
Konak, Izmir, Turkey, 35180
Hacettepe University Medical Faculty /ID# 131150
Ankara, Turkey, 06100
Ankara Univ Medical Faculty /ID# 131151
Ankara, Turkey, 6100
Uludag University Medical Faculty /ID# 132297
Bursa, Turkey, 16059
Istanbul University Istanbul Medical Faculty /ID# 131153
Istanbul, Turkey, 34093
Ege University Medical Faculty /ID# 132298
Izmir, Turkey, 35040
Karadeniz University /ID# 131152
Trabzon, Turkey, 61000
United Kingdom
The Royal London Hospital /ID# 132302
London, London, City Of, United Kingdom, E1 1BB
The Royal Free Hospital /ID# 131159
London, London, City Of, United Kingdom, NW3 2QG
Univ Hospitals Birmingham NHS Foundation trust /ID# 131154
Birmingham, United Kingdom, B15 2TG
The Royal Bournemouth Hospital /ID# 132306
Bournemouth, United Kingdom, BH7 7DW
North Manchester General /ID# 131156
Crumpsall, United Kingdom, M8 5RB
Ninewells Hospital /ID# 132300
Dundee, United Kingdom, DD1 9SY
Western General Hospital /ID# 134368
Edinburgh, United Kingdom, EH4 2XU
Gartnavel General Hospital /ID# 131162
Glasgow, United Kingdom, G12 0YN
St. James University Hospital /ID# 132305
Leeds, United Kingdom, LS9 7TF
King's College Hospital NHS /ID# 131157
London, United Kingdom, SE5 9RS
St. George's Healthcare NHS /ID# 132301
London, United Kingdom, SW17 0QT
Nottingham University /ID# 131155
Nottingham, United Kingdom, NG7 2UH
Derriford Hospital /ID# 131160
Plymouth, United Kingdom, PL6 8DH
Queen Alexandra Hospital /ID# 131158
Portsmouth, United Kingdom, PO6 3LY
Southampton General Hospital /ID# 131161
Southampton, United Kingdom, SO16 6YD

Sponsors and Collaborators

AbbVie

Investigators

Study Director: AbbVie Inc. 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: May 31, 2018  
Individual Participant Data    
Plan to Share IPD: Undecided  

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
Cirrhosis
Naive
Treatment-Experienced
Relapser
Null responder
Non responder

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 July 20, 2018
This information is provided by ClinicalTrials.gov.