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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/NCT02167945




Registration number
NCT02167945
Ethics application status
Date submitted
18/06/2014
Date registered
19/06/2014
Date last updated
19/07/2022

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-II)
Secondary ID [1] 0 0
M14-222
Universal Trial Number (UTN)
Trial acronym
TOPAZ-II
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
Percentage of Participants With Sustained Virologic Response 12 Weeks Post-treatment (SVR12)
Timepoint [1] 0 0
12 weeks after the last actual dose of study drug
Secondary outcome [2] 0 0
Mean Change From Baseline in Short Form 36 Version 2.0 (SF-36 V2) Physical Component Summary (PCS) Score at Post-Treatment Week 12 and Post-Treatment Week 24
Timepoint [2] 0 0
From Baseline to Post-Treatment Week 12 and Post-Treatment Week 24
Secondary outcome [3] 0 0
Mean Change From Baseline in Short Form 36 Version 2.0 (SF-36 V2) Mental Component Summary (MCS) Score at Post-Treatment Week 12 and Post-Treatment Week 24
Timepoint [3] 0 0
From Baseline to Post-Treatment Week 12 and Post-Treatment Week 24
Secondary outcome [4] 0 0
Mean Change From Baseline in Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F) Total Score at Post-Treatment Week 12 and Post-Treatment Week 24
Timepoint [4] 0 0
From Baseline to Post-Treatment Week 12 and Post-Treatment Week 24
Secondary outcome [5] 0 0
Treatment Compliance: Percentage of Tablets Taken Relative to the Total Tablets
Timepoint [5] 0 0
Up to Treatment Week 24

Eligibility
Key inclusion criteria
1. Females must be post-menopausal for more than 2 years or surgically sterile or
practicing specific forms of birth control

2. Chronic hepatitis C, genotype 1-infection (HCV RNA level greater than 1,000 IU/mL at
screening)

3. HCV genotype 1 infection per screening laboratory result
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. Positive hepatitis B surface antigen and anti-Human Immunodeficiency Virus Antibody

4. History of solid organ transplant, clinical evidence of Child-Pugh B or C
classification or clinical history of liver decompensation

5. Presence of hepatocellular carcinoma at screening

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
12/06/2014
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
13/05/2021
Sample size
Target
Accrual to date
Final
615
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
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United States of America
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Arizona
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California
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Colorado
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District of Columbia
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Florida
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Georgia
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Illinois
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Indiana
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Louisiana
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Maryland
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Massachusetts
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Michigan
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Minnesota
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Missouri
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New Jersey
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State/province [16] 0 0
New Mexico
Country [17] 0 0
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New York
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North Carolina
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Ohio
Country [20] 0 0
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Oklahoma
Country [21] 0 0
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Rhode Island
Country [22] 0 0
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Tennessee
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Texas
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Utah
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Washington
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United States of America
State/province [26] 0 0
Wisconsin

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/NCT02167945
Trial related presentations / publications
Public notes
This record is viewable in the ANZCTR as it had previously listed Australia and/or New Zealand as a recruitment site, however these sites have since been removed

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