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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT02219490




Registration number
NCT02219490
Ethics application status
Date submitted
15/08/2014
Date registered
19/08/2014

Titles & IDs
Public title
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
Scientific 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)
Secondary ID [1] 0 0
2014-001022-14
Secondary ID [2] 0 0
M14-423
Universal Trial Number (UTN)
Trial acronym
TOPAZ-I
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic Hepatitis C Virus (HCV) Infection Genotype 1 0 0
Condition category
Condition code
Infection 0 0 0 0
Studies of infection and infectious agents
Infection 0 0 0 0
Other infectious diseases
Infection 0 0 0 0
Sexually transmitted infections
Oral and Gastrointestinal 0 0 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - ABT-450/r/ABT-267
Treatment: Drugs - ABT-333
Treatment: Drugs - Ribavirin (RBV)

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.


Treatment: Drugs: ABT-450/r/ABT-267
Tablet for oral use

Treatment: Drugs: ABT-333
Tablet for oral use

Treatment: Drugs: 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 code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
All-Cause Death: Time to Event
Timepoint [1] 0 0
At Post-Treatment Weeks 52, 104, 156, 208, and 260
Primary outcome [2] 0 0
Liver-Related Death: Time to Event
Timepoint [2] 0 0
At Post-Treatment Weeks 52, 104, 156, 208, and 260
Primary outcome [3] 0 0
Liver Decompensation: Time to Event
Timepoint [3] 0 0
At Post-Treatment Weeks 52, 104, 156, 208, and 260
Primary outcome [4] 0 0
Liver Transplantation: Time to Event
Timepoint [4] 0 0
At Post-Treatment Weeks 52, 104, 156, 208, and 260
Primary outcome [5] 0 0
Hepatocellular Carcinoma: Time to Event
Timepoint [5] 0 0
At Post-Treatment Weeks 52, 104, 156, 208, and 260
Primary outcome [6] 0 0
All-Cause Death, Liver-Related Death, Liver Decompensation, Liver Transplantation, Hepatocellular Carcinoma: Time to Event
Timepoint [6] 0 0
At Post-Treatment Weeks 52, 104, 156, 208, and 260
Secondary outcome [1] 0 0
Change From Baseline in FibroScan Score by SVR12 Status
Timepoint [1] 0 0
At the final treatment visit and Post-Treatment Weeks 12, 24, 52, 104, 156, 208, and 260
Secondary outcome [2] 0 0
Percentage of Participants With Sustained Virologic Response 12 Weeks Post-treatment (SVR12)
Timepoint [2] 0 0
12 weeks after the last actual dose of study drug

Eligibility
Key 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
Minimum age
18 Years
Maximum age
99 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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 design
Purpose of the study
Treatment
Allocation to intervention
Not applicable
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
30/10/2014
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
13/05/2021
Sample size
Target
Accrual to date
Final
1596
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC
Recruitment hospital [1] 0 0
St Vincent's Hospital Sydney /ID# 131001 - Darlinghurst
Recruitment hospital [2] 0 0
Nepean Hospital /ID# 130999 - Kingswood
Recruitment hospital [3] 0 0
Westmead Hospital /ID# 130997 - Westmead
Recruitment hospital [4] 0 0
Greenslopes Private Hospital /ID# 131003 - Greenslopes
Recruitment hospital [5] 0 0
Royal Brisbane and Women's Hospital /ID# 131004 - Herston
Recruitment hospital [6] 0 0
Royal Adelaide Hospital /ID# 131002 - Adelaide
Recruitment hospital [7] 0 0
St Vincent's Hospital Melbourne /ID# 131000 - Fitzroy Melbourne
Recruitment hospital [8] 0 0
The Royal Melbourne Hospital /ID# 130998 - Parkville
Recruitment postcode(s) [1] 0 0
2010 - Darlinghurst
Recruitment postcode(s) [2] 0 0
2747 - Kingswood
Recruitment postcode(s) [3] 0 0
2145 - Westmead
Recruitment postcode(s) [4] 0 0
4120 - Greenslopes
Recruitment postcode(s) [5] 0 0
4029 - Herston
Recruitment postcode(s) [6] 0 0
5000 - Adelaide
Recruitment postcode(s) [7] 0 0
3065 - Fitzroy Melbourne
Recruitment postcode(s) [8] 0 0
3050 - Parkville
Recruitment outside Australia
Country [1] 0 0
Algeria
State/province [1] 0 0
Algiers
Country [2] 0 0
Austria
State/province [2] 0 0
Oberoesterreich
Country [3] 0 0
Austria
State/province [3] 0 0
Steiermark
Country [4] 0 0
Austria
State/province [4] 0 0
Wien
Country [5] 0 0
Belgium
State/province [5] 0 0
Bruxelles-Capitale
Country [6] 0 0
Belgium
State/province [6] 0 0
Vlaams-Brabant
Country [7] 0 0
Bulgaria
State/province [7] 0 0
Sofia
Country [8] 0 0
Bulgaria
State/province [8] 0 0
Varna
Country [9] 0 0
Canada
State/province [9] 0 0
Alberta
Country [10] 0 0
Canada
State/province [10] 0 0
British Columbia
Country [11] 0 0
Canada
State/province [11] 0 0
Manitoba
Country [12] 0 0
Canada
State/province [12] 0 0
New Brunswick
Country [13] 0 0
Canada
State/province [13] 0 0
Ontario
Country [14] 0 0
Canada
State/province [14] 0 0
Quebec
Country [15] 0 0
Denmark
State/province [15] 0 0
Hovedstaden
Country [16] 0 0
Denmark
State/province [16] 0 0
Syddanmark
Country [17] 0 0
Denmark
State/province [17] 0 0
Aarhus
Country [18] 0 0
Finland
State/province [18] 0 0
Uusimaa
Country [19] 0 0
Finland
State/province [19] 0 0
Turku
Country [20] 0 0
France
State/province [20] 0 0
Bouches-du-Rhone
Country [21] 0 0
France
State/province [21] 0 0
Franche-Comte
Country [22] 0 0
France
State/province [22] 0 0
Gironde
Country [23] 0 0
France
State/province [23] 0 0
Herault
Country [24] 0 0
France
State/province [24] 0 0
Pays-de-la-Loire
Country [25] 0 0
France
State/province [25] 0 0
Bondy
Country [26] 0 0
France
State/province [26] 0 0
La Tronche
Country [27] 0 0
France
State/province [27] 0 0
Lyon
Country [28] 0 0
France
State/province [28] 0 0
Nice
Country [29] 0 0
France
State/province [29] 0 0
Rennes
Country [30] 0 0
France
State/province [30] 0 0
Strasbourg cedex
Country [31] 0 0
France
State/province [31] 0 0
Toulouse
Country [32] 0 0
Germany
State/province [32] 0 0
Baden-Wuerttemberg
Country [33] 0 0
Germany
State/province [33] 0 0
Bayern
Country [34] 0 0
Germany
State/province [34] 0 0
Hessen
Country [35] 0 0
Germany
State/province [35] 0 0
Nordrhein-Westfalen
Country [36] 0 0
Germany
State/province [36] 0 0
Berlin
Country [37] 0 0
Germany
State/province [37] 0 0
Essen
Country [38] 0 0
Germany
State/province [38] 0 0
Hamburg
Country [39] 0 0
Germany
State/province [39] 0 0
Hannover
Country [40] 0 0
Germany
State/province [40] 0 0
Muenster
Country [41] 0 0
Greece
State/province [41] 0 0
Attiki
Country [42] 0 0
Greece
State/province [42] 0 0
Alexandroupolis
Country [43] 0 0
Ireland
State/province [43] 0 0
Dublin
Country [44] 0 0
Israel
State/province [44] 0 0
Tel-Aviv
Country [45] 0 0
Israel
State/province [45] 0 0
Haifa
Country [46] 0 0
Italy
State/province [46] 0 0
Emilia-Romagna
Country [47] 0 0
Italy
State/province [47] 0 0
Ferrara
Country [48] 0 0
Italy
State/province [48] 0 0
Foggia
Country [49] 0 0
Italy
State/province [49] 0 0
Lazio
Country [50] 0 0
Italy
State/province [50] 0 0
Lombardia
Country [51] 0 0
Italy
State/province [51] 0 0
Roma
Country [52] 0 0
Italy
State/province [52] 0 0
Bergamo
Country [53] 0 0
Italy
State/province [53] 0 0
Florence
Country [54] 0 0
Italy
State/province [54] 0 0
Messina
Country [55] 0 0
Italy
State/province [55] 0 0
Milano
Country [56] 0 0
Italy
State/province [56] 0 0
Milan
Country [57] 0 0
Italy
State/province [57] 0 0
Napoli
Country [58] 0 0
Italy
State/province [58] 0 0
Palermo
Country [59] 0 0
Italy
State/province [59] 0 0
Parma
Country [60] 0 0
Italy
State/province [60] 0 0
Salerno
Country [61] 0 0
Italy
State/province [61] 0 0
Turin
Country [62] 0 0
Italy
State/province [62] 0 0
Udine
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Mexico
State/province [63] 0 0
Baja California
Country [64] 0 0
Mexico
State/province [64] 0 0
Jalisco
Country [65] 0 0
Mexico
State/province [65] 0 0
Ciudad de Mexico
Country [66] 0 0
Mexico
State/province [66] 0 0
Delegacion Tlalpan
Country [67] 0 0
Mexico
State/province [67] 0 0
Distrito Federal
Country [68] 0 0
Mexico
State/province [68] 0 0
Mexico City
Country [69] 0 0
Netherlands
State/province [69] 0 0
Zuid-Holland
Country [70] 0 0
Netherlands
State/province [70] 0 0
Amsterdam
Country [71] 0 0
Netherlands
State/province [71] 0 0
Leiden
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Norway
State/province [72] 0 0
Akershus
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Norway
State/province [73] 0 0
Sor-Trondelag
Country [74] 0 0
Norway
State/province [74] 0 0
Stavanger
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Poland
State/province [75] 0 0
Kujawsko-pomorskie
Country [76] 0 0
Poland
State/province [76] 0 0
Lodzkie
Country [77] 0 0
Poland
State/province [77] 0 0
Lubelskie
Country [78] 0 0
Poland
State/province [78] 0 0
Mazowieckie
Country [79] 0 0
Poland
State/province [79] 0 0
Podlaskie
Country [80] 0 0
Poland
State/province [80] 0 0
Slaskie
Country [81] 0 0
Portugal
State/province [81] 0 0
Coimbra
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Portugal
State/province [82] 0 0
Lisboa
Country [83] 0 0
Portugal
State/province [83] 0 0
Porto
Country [84] 0 0
Romania
State/province [84] 0 0
Bucuresti
Country [85] 0 0
Romania
State/province [85] 0 0
Timis
Country [86] 0 0
Romania
State/province [86] 0 0
Iasi
Country [87] 0 0
Russian Federation
State/province [87] 0 0
Samarskaya Oblast
Country [88] 0 0
Russian Federation
State/province [88] 0 0
Tatarstan, Respublika
Country [89] 0 0
Russian Federation
State/province [89] 0 0
Chelyabinsk
Country [90] 0 0
Russian Federation
State/province [90] 0 0
Kemerovo
Country [91] 0 0
Russian Federation
State/province [91] 0 0
Krasnoyarsk
Country [92] 0 0
Russian Federation
State/province [92] 0 0
Moscow
Country [93] 0 0
Russian Federation
State/province [93] 0 0
Novosibirsk
Country [94] 0 0
Russian Federation
State/province [94] 0 0
Samara
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Russian Federation
State/province [95] 0 0
Stavropol
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Russian Federation
State/province [96] 0 0
Tolyatti
Country [97] 0 0
Russian Federation
State/province [97] 0 0
Tyumen
Country [98] 0 0
Russian Federation
State/province [98] 0 0
Yekaterinburg
Country [99] 0 0
Saudi Arabia
State/province [99] 0 0
Jeddah
Country [100] 0 0
Saudi Arabia
State/province [100] 0 0
Riyadh
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Spain
State/province [101] 0 0
Asturias
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Spain
State/province [102] 0 0
Barcelona
Country [103] 0 0
Spain
State/province [103] 0 0
Cantabria
Country [104] 0 0
Spain
State/province [104] 0 0
Guipuzcoa
Country [105] 0 0
Spain
State/province [105] 0 0
Illes Balears
Country [106] 0 0
Spain
State/province [106] 0 0
Murcia
Country [107] 0 0
Spain
State/province [107] 0 0
Vizcaya
Country [108] 0 0
Spain
State/province [108] 0 0
A Coruna
Country [109] 0 0
Spain
State/province [109] 0 0
Cordoba
Country [110] 0 0
Spain
State/province [110] 0 0
Madrid
Country [111] 0 0
Spain
State/province [111] 0 0
Malaga
Country [112] 0 0
Spain
State/province [112] 0 0
Sevilla
Country [113] 0 0
Spain
State/province [113] 0 0
Zaragoza
Country [114] 0 0
Sweden
State/province [114] 0 0
Skane Lan
Country [115] 0 0
Sweden
State/province [115] 0 0
Stockholms Lan
Country [116] 0 0
Sweden
State/province [116] 0 0
Vastra Gotalands Lan
Country [117] 0 0
Switzerland
State/province [117] 0 0
Sankt Gallen
Country [118] 0 0
Switzerland
State/province [118] 0 0
Zuerich
Country [119] 0 0
Switzerland
State/province [119] 0 0
Bern
Country [120] 0 0
Turkey
State/province [120] 0 0
Izmir
Country [121] 0 0
Turkey
State/province [121] 0 0
Ankara
Country [122] 0 0
Turkey
State/province [122] 0 0
Bursa
Country [123] 0 0
Turkey
State/province [123] 0 0
Istanbul
Country [124] 0 0
Turkey
State/province [124] 0 0
Trabzon
Country [125] 0 0
United Kingdom
State/province [125] 0 0
Dorset
Country [126] 0 0
United Kingdom
State/province [126] 0 0
Hampshire
Country [127] 0 0
United Kingdom
State/province [127] 0 0
London, City Of
Country [128] 0 0
United Kingdom
State/province [128] 0 0
Nottinghamshire
Country [129] 0 0
United Kingdom
State/province [129] 0 0
Scotland
Country [130] 0 0
United Kingdom
State/province [130] 0 0
Birmingham
Country [131] 0 0
United Kingdom
State/province [131] 0 0
Dundee
Country [132] 0 0
United Kingdom
State/province [132] 0 0
Edinburgh
Country [133] 0 0
United Kingdom
State/province [133] 0 0
Leeds
Country [134] 0 0
United Kingdom
State/province [134] 0 0
London
Country [135] 0 0
United Kingdom
State/province [135] 0 0
Plymouth
Country [136] 0 0
United Kingdom
State/province [136] 0 0
Portsmouth
Country [137] 0 0
United Kingdom
State/province [137] 0 0
Salford
Country [138] 0 0
United Kingdom
State/province [138] 0 0
Tooting

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
AbbVie
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
ABBVIE INC.
Address 0 0
AbbVie
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
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

Supporting document/s available: Study protocol, Statistical analysis plan (SAP), Clinical study report (CSR)
When will data be available (start and end dates)?
For details on when studies are available for sharing, please refer to the link below.
Available to whom?
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.
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: https://vivli.org/ourmember/abbvie/


What supporting documents are/will be available?




Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results are available at https://clinicaltrials.gov/study/NCT02219490