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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT01457768
Registration number
NCT01457768
Ethics application status
Date submitted
4/10/2011
Date registered
24/10/2011
Date last updated
4/05/2018
Titles & IDs
Public title
A Gilead Sequence Registry of Subjects Who Did Not Achieve Sustained Virologic Response
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Scientific title
A Long Term Follow-up Registry Study of Subjects Who Did Not Achieve Sustained Virologic Response in Gilead-Sponsored Trials in Subjects With Chronic Hepatitis C Infection
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Secondary ID [1]
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2011-000946-39
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Secondary ID [2]
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GS-US-248-0123
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Hepatitis C, Chronic
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Condition category
Condition code
Infection
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0
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Other infectious diseases
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Oral and Gastrointestinal
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0
0
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
Observational
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Patient registry
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Target follow-up duration
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Target follow-up type
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Description of intervention(s) / exposure
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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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Proportion of participants with at least one drug resistant mutation (DRM) loss from enrollment to end of study by treatment regimen
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Assessment method [1]
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0
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Timepoint [1]
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Up to 3 years
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Secondary outcome [1]
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Proportion of participants with DRM loss by unit category, 1, 2, 3,…n, by treatment regimen
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Assessment method [1]
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0
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Timepoint [1]
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Up to 3 years
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Secondary outcome [2]
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Average number of DRM loss by treatment regimen
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Assessment method [2]
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0
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Timepoint [2]
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Up to 3 years
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Secondary outcome [3]
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Liver disease progression
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Assessment method [3]
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Liver disease progression is a composite endpoint measured by laboratory parameters (alanine aminotransferase (ALT), aspartate aminotransferase (AST), bilirubin, albumin, platelets, prothrombin time (PT) and a-fetoprotein) and observed or reported clinical signs and symptoms.
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Timepoint [3]
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Up to 3 years
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Secondary outcome [4]
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Proportion of participants who develop hepatocellular carcinoma (HCC) through Week 144 by treatment regimen
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Assessment method [4]
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0
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Timepoint [4]
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Up to 144 weeks
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Eligibility
Key inclusion criteria
Key
* Have previously participated in a Gilead-sponsored hepatitis C study and received at least one Gilead OAV
* Have failed to achieve an SVR in a previous Gilead-sponsored study, as defined in the original treatment protocol
* Provide written, informed consent
* Be willing and able to comply with the visit schedule
Key
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Minimum age
18
Years
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Maximum age
No limit
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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
* Individuals planning to start a new course of hepatitis C therapy including any investigational drug or device during the course of the follow-up Registry
* History of clinically significant illness or any other major medical disorder that may interfere with follow-up, assessments or compliance with the protocol
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
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Study design
Purpose
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Duration
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Selection
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Timing
Prospective
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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
19/12/2011
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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
9/04/2018
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Sample size
Target
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Accrual to date
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Final
570
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Recruitment in Australia
Recruitment state(s)
ACT,NSW,QLD,SA,VIC,WA
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Recruitment hospital [1]
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Canberra Specialist Centre - Canberra
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Recruitment hospital [2]
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Royal Prince Alfred Hospital - Camperdown
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Recruitment hospital [3]
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102 Burton Street - Darlinghurst
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East Sydney Doctors - Darlinghurst
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St Vincent's Public Hospital Sydney - Darlinghurst
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Liverpool Hospital - Liverpool
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Westmead Hospital - Westmead
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Greenslopes Private Hospital - Woolloongabba
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Flinders Medical Centre - Bedford Park
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Footscray Hospital - Footscray
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Austin Health - Heidelberg
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Alfred Hospital - Infectious Disease Unit - Melbourne
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Alfred Hospital - Melbourne
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Monash Medical Centre - Melbourne
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Fiona Stanley Hospital - Murdoch
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Recruitment hospital [16]
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Royal Perth Hospital - Perth
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St Vincent's University Hospital - Fitzroy
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Royal Brisbane & Women's Hospital - QLD
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Recruitment hospital [19]
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Princess Alexandra Hospital - Woolloongabba
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Recruitment postcode(s) [1]
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- Canberra
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Recruitment postcode(s) [2]
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2050 - Camperdown
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Recruitment postcode(s) [3]
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2010 - Darlinghurst
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Recruitment postcode(s) [4]
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- Darlinghurst
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Recruitment postcode(s) [5]
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2170 - Liverpool
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Recruitment postcode(s) [6]
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2145 - Westmead
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4102 - Woolloongabba
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Recruitment postcode(s) [8]
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5042 - Bedford Park
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- Footscray
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- Heidelberg
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3004 - Melbourne
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3168 - Melbourne
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- Murdoch
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6000 - Perth
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3065 - Fitzroy
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4029 - QLD
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Recruitment outside Australia
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Bristol
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Plymouth
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Gilead Sciences
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Address
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Ethics approval
Ethics application status
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Summary
Brief summary
This Registry is designed to obtain long term data on participants who have failed to achieve sustained virologic response (SVR) while receiving at least one Gilead oral antiviral agent (OAV) in a previous Gilead-sponsored hepatitis C virus (HCV) study.
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Trial website
https://clinicaltrials.gov/study/NCT01457768
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Trial related presentations / publications
Younossi ZM, Stepanova M, Racila A, Afendy A, Lawitz EJ, Schwabe C, Ruane PJ, Lalezari J, Reddy KR, Jacobson IM, Muir AJ, Gaggar A, Myers RP, Younossi I, Nader F. Long-term Benefits of Sustained Virologic Response for Patient-Reported Outcomes in Patients With Chronic Hepatitis C Virus Infection. Clin Gastroenterol Hepatol. 2020 Feb;18(2):468-476.e11. doi: 10.1016/j.cgh.2019.07.047. Epub 2019 Jul 31. Younossi ZM, Stepanova M, Jacobson I, Muir AJ, Pol S, Zeuzem S, Younes Z, Herring R, Lawitz E, Younossi I, Racila A. Not Achieving Sustained Viral Eradication of Hepatitis C Virus After Treatment Leads to Worsening Patient-reported Outcomes. Clin Infect Dis. 2020 Feb 3;70(4):628-632. doi: 10.1093/cid/ciz243.
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Gilead Study Director
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Gilead Sciences
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https://clinicaltrials.gov/study/NCT01457768
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