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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
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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)
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Secondary ID [1]
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0
2014-001022-14
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Secondary ID [2]
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0
M14-423
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Universal Trial Number (UTN)
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Trial acronym
TOPAZ-I
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Chronic Hepatitis C Virus (HCV) Infection Genotype 1
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0
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Condition category
Condition code
Infection
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Studies of infection and infectious agents
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Infection
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0
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Other infectious diseases
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Infection
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Sexually transmitted infections
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Oral and Gastrointestinal
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0
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Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
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Intervention/exposure
Study type
Interventional
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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.
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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All-Cause Death: Time to Event
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Assessment method [1]
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Time to all-cause death was defined as the number of days from the first day of study drug dosing for the participant to the date of death. All deaths were to be included, regardless of whether the death occurred while the participant was still taking study drug or had previously discontinued study drug. If the participant did not die, their data was to be censored at the date of their last available assessment of clinical outcomes. For participants with no post-baseline assessment, the participant's data was to be censored on the first day of study drug dosing. The event-free survival rates were estimated using Kaplan-Meier methodology and incidence estimates are presented with 95% confidence intervals. The pre-specified analysis of all-cause death included pooled data from TOPAZ-I (this study) and the companion study TOPAZ-II (M14-222; NCT02167945).
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Timepoint [1]
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At Post-Treatment Weeks 52, 104, 156, 208, and 260
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Primary outcome [2]
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Liver-Related Death: Time to Event
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Assessment method [2]
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Time to liver-related death was defined as days from the 1st day of study drug dosing for the subject to date of liver-related death. All liver-related deaths were to be included, regardless of whether the death occurred while subject was still taking study drug or had previously discontinued study drug. If the subject didn't experience event of interest nor had died (all-cause death), their data was to be censored at date of last available assessment. For those with no post-baseline assessment, data was to be censored on 1st day of study drug dosing. All-cause death was a censoring event for liver-related death. The event-free survival rates were estimated using Kaplan-Meier methodology and incidence estimates are presented with 95% confidence intervals. The pre-specified analysis of liver-related death included pooled data from TOPAZ-I (this study) and the companion study TOPAZ-II (M14-222; NCT02167945).
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Timepoint [2]
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At Post-Treatment Weeks 52, 104, 156, 208, and 260
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Primary outcome [3]
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Liver Decompensation: Time to Event
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Assessment method [3]
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Time to liver decompensation was defined as number of days from the 1st day of study drug dosing for the participant to the date of liver decompensation. All liver decompensation was to be included, regardless of whether it occurred while the participant was still taking study drug or had previously discontinued study drug. If the participant didn't experience the event of interest nor had died (all-cause death), their data was to be censored at the date of their last available assessment of clinical outcomes. For participants with no post-baseline assessment, their data was to be censored on the 1st day of study drug dosing. All-cause death was a censoring event for liver decompensation. The event-free survival rates were estimated using Kaplan-Meier methodology and incidence estimates are presented with 95% confidence intervals. The pre-specified analysis of liver decompensation included pooled data from TOPAZ-I (this study) and the companion study TOPAZ-II (M14-222; NCT02167945).
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Timepoint [3]
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At Post-Treatment Weeks 52, 104, 156, 208, and 260
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Primary outcome [4]
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Liver Transplantation: Time to Event
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Assessment method [4]
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Time to liver transplantation was defined as days from 1st day of study drug dosing for subject to date of liver transplantation. All liver transplantation was to be included, whether it occurred while the subject was still taking study drug or had previously discontinued study drug. If the subject didn't experience event of interest nor had died (all-cause death), their data was to be censored at the date of their last available assessment. For those with no post-baseline assessment, data was to be censored on 1st day of study drug dosing. All-cause death was a censoring event for liver transplantation. The event-free survival rates were estimated using Kaplan-Meier methodology and incidence estimates are presented with 95% confidence intervals. The pre-specified analysis of liver transplantation included pooled data from TOPAZ-I (this study) and the companion study TOPAZ-II (M14-222; NCT02167945).
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Timepoint [4]
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At Post-Treatment Weeks 52, 104, 156, 208, and 260
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Primary outcome [5]
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Hepatocellular Carcinoma: Time to Event
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Assessment method [5]
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Time to hepatocellular carcinoma (HCC) was defined as number of days from 1st day of study drug dosing for subject to date of hepatocellular carcinoma. All HCC was to be included, whether it occurred while subject was still taking study drug or had previously discontinued study drug. If the subject didn't experience the event of interest nor had died (all-cause death), their data was to be censored at the date of their last available assessment. For those with no post-baseline assessment, their data was to be censored on the 1st day of study drug dosing. All-cause death was a censoring event for HCC. The event-free survival rates were estimated using Kaplan-Meier methodology and incidence estimates are presented with 95% confidence intervals. The pre-specified analysis of hepatocellular carcinoma included pooled data from TOPAZ-I (this study) and the companion study TOPAZ-II (M14-222; NCT02167945).
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Timepoint [5]
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At Post-Treatment Weeks 52, 104, 156, 208, and 260
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Primary outcome [6]
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All-Cause Death, Liver-Related Death, Liver Decompensation, Liver Transplantation, Hepatocellular Carcinoma: Time to Event
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Assessment method [6]
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Time to the composite of clinical outcomes is the time to the first occurrence of all-cause death, liver-related death, liver decompensation, liver transplantation, or hepatocellular carcinoma. All first occurrences were to be included, regardless of whether it occurred while the participant was still taking study drug or had previously discontinued study drug. If the participant did not experience any of these events, their data was to be censored at the date of their last available assessment of clinical outcomes. For participants with no post-baseline assessment, the participant's data was to be censored on the first day of study drug dosing. The event-free survival rates were estimated using Kaplan-Meier methodology and incidence estimates are presented with 95% confidence intervals. Pre-specified analysis included pooled data from this study and from TOPAZ-II; NCT02167945.
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Timepoint [6]
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At Post-Treatment Weeks 52, 104, 156, 208, and 260
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Secondary outcome [1]
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Change From Baseline in FibroScan Score by SVR12 Status
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Assessment method [1]
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The FibroScan test is a validated non-invasive test used to assess liver fibrosis in participants with chronic liver disease, and it was performed at study sites where it was available. For participants with Hepatitis C infection, a FibroScan score of 2-7 kPa indicates no liver scarring or mild scarring; a score of 8 or 9 is associated with moderate liver scarring; 9-14 indicates severe liver scarring; and 14 or higher is indicative of advanced liver scarring, cirrhosis. Negative changes from baseline indicate improvement in liver fibrosis.
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Timepoint [1]
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At the final treatment visit and Post-Treatment Weeks 12, 24, 52, 104, 156, 208, and 260
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Secondary outcome [2]
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Percentage of Participants With Sustained Virologic Response 12 Weeks Post-treatment (SVR12)
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Assessment method [2]
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SVR12 is defined as hepatitis C virus ribonucleic acid (HCV RNA) less than the lower limit of quantification (LLOQ) 12 weeks after the last actual dose of study drug. Flanking imputation, where applicable, was used to impute missing data. After applying flanking imputation, if there was no value in the window but there was an HCV RNA value from a local laboratory present, then it was to be imputed into the SVR window. Otherwise, participants with missing data were counted as failures.
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Timepoint [2]
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12 weeks after the last actual dose of study drug
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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
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Minimum age
18
Years
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Maximum age
99
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Sex
Both males and females
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Can healthy volunteers participate?
No
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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
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Study design
Purpose of the study
Treatment
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Allocation to intervention
NA
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Single group
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
30/10/2014
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
13/05/2021
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Sample size
Target
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Accrual to date
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Final
1596
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Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC
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Recruitment hospital [1]
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St Vincent's Hospital Sydney /ID# 131001 - Darlinghurst
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Recruitment hospital [2]
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Nepean Hospital /ID# 130999 - Kingswood
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Recruitment hospital [3]
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Westmead Hospital /ID# 130997 - Westmead
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Recruitment hospital [4]
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Greenslopes Private Hospital /ID# 131003 - Greenslopes
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Recruitment hospital [5]
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Royal Brisbane and Women's Hospital /ID# 131004 - Herston
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Royal Adelaide Hospital /ID# 131002 - Adelaide
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Recruitment hospital [7]
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St Vincent's Hospital Melbourne /ID# 131000 - Fitzroy Melbourne
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Recruitment hospital [8]
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The Royal Melbourne Hospital /ID# 130998 - Parkville
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Recruitment postcode(s) [1]
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2010 - Darlinghurst
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Recruitment postcode(s) [2]
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2747 - Kingswood
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Recruitment postcode(s) [3]
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2145 - Westmead
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Recruitment postcode(s) [4]
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4120 - Greenslopes
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Recruitment postcode(s) [5]
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4029 - Herston
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Recruitment postcode(s) [6]
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5000 - Adelaide
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Recruitment postcode(s) [7]
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3065 - Fitzroy Melbourne
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Recruitment postcode(s) [8]
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3050 - Parkville
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Recruitment outside Australia
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Algeria
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Iasi
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Russian Federation
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Samarskaya Oblast
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Russian Federation
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Tatarstan, Respublika
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Russian Federation
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Chelyabinsk
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Russian Federation
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Kemerovo
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Russian Federation
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Krasnoyarsk
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Russian Federation
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Moscow
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Russian Federation
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Novosibirsk
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Russian Federation
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Samara
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Russian Federation
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Stavropol
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Russian Federation
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Tolyatti
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Russian Federation
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Tyumen
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Russian Federation
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Yekaterinburg
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Saudi Arabia
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Jeddah
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Saudi Arabia
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Riyadh
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Spain
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Asturias
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Spain
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Barcelona
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Spain
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Cantabria
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Spain
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Guipuzcoa
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Spain
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Illes Balears
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Spain
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Murcia
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Spain
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Vizcaya
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Spain
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State/province [108]
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A Coruna
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Spain
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Cordoba
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Spain
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Madrid
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Country [111]
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Spain
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Malaga
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Spain
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Sevilla
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Spain
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Zaragoza
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Country [114]
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Sweden
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State/province [114]
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Skane Lan
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Sweden
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State/province [115]
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Stockholms Lan
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Sweden
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State/province [116]
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Vastra Gotalands Lan
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Switzerland
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State/province [117]
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Sankt Gallen
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Country [118]
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Switzerland
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Zuerich
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Switzerland
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Bern
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Country [120]
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Turkey
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Izmir
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Turkey
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Ankara
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Turkey
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Bursa
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Country [123]
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Turkey
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Istanbul
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Turkey
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Trabzon
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Country [125]
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United Kingdom
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Dorset
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Country [126]
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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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Country [128]
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United Kingdom
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Nottinghamshire
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Country [129]
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United Kingdom
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Scotland
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United Kingdom
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Birmingham
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United Kingdom
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Dundee
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Country [132]
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United Kingdom
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Edinburgh
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Country [133]
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United Kingdom
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Leeds
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United Kingdom
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London
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United Kingdom
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Plymouth
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United Kingdom
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Portsmouth
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United Kingdom
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Salford
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United Kingdom
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Tooting
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
AbbVie
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Address
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Country
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Ethics approval
Ethics application status
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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.
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Trial website
https://clinicaltrials.gov/study/NCT02219490
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
0
0
ABBVIE INC.
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Address
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AbbVie
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0
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Contact person for public queries
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Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
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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)
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When will data be available (start and end dates)?
For details on when studies are available for sharing, please refer to the link below.
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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.
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Available for what types of analyses?
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How or where can data be obtained?
IPD available at link: https://vivli.org/ourmember/abbvie/
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What supporting documents are/will be available?
No Supporting Document Provided
Type
Other Details
Attachment
Study protocol
https://cdn.clinicaltrials.gov/large-docs/90/NCT02219490/Prot_000.pdf
Statistical analysis plan
https://cdn.clinicaltrials.gov/large-docs/90/NCT02219490/SAP_001.pdf
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT02219490