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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT02219490




Registration number
NCT02219490
Ethics application status
Date submitted
15/08/2014
Date registered
19/08/2014
Date last updated
7/04/2023

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
N/A
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
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Algeria
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Algiers
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Austria
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Oberoesterreich
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Austria
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Steiermark
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Wien
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Belgium
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Bruxelles-Capitale
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Vlaams-Brabant
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Bulgaria
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Sofia
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Varna
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Alberta
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British Columbia
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Manitoba
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Ontario
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Hovedstaden
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Aarhus
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Finland
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Uusimaa
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Finland
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Turku
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France
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Gironde
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Herault
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Pays-de-la-Loire
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Bondy
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Lyon
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Rennes
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Toulouse
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Bayern
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Muenster
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Attiki
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Distrito Federal
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Murcia
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Vizcaya
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Sweden
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Stockholms Lan
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Sankt Gallen
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Zuerich
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Bern
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Izmir
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Ankara
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Bursa
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Istanbul
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Turkey
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Trabzon
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United Kingdom
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Dorset
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United Kingdom
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Hampshire
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United Kingdom
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London, City Of
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Nottinghamshire
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Scotland
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Birmingham
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Dundee
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Edinburgh
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Leeds
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London
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Plymouth
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Portsmouth
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Salford
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United Kingdom
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Tooting

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

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT02219490
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