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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT01457755
Registration number
NCT01457755
Ethics application status
Date submitted
4/10/2011
Date registered
24/10/2011
Date last updated
31/08/2018
Titles & IDs
Public title
Gilead Sustained Virologic Response (SVR) Registry
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Scientific title
A Long Term Follow-up Registry for Subjects Who Achieve a Sustained Virologic Response to Treatment in Gilead-Sponsored Trials in Subjects With Chronic Hepatitis C Infection
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Secondary ID [1]
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0
2011-000945-19
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Secondary ID [2]
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GS-US-248-0122
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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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0
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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
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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
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 maintaining SVR at Week 144 by treatment regimen
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Assessment method [1]
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Timepoint [1]
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Week 144
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Secondary outcome [1]
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Proportion of participants with detectable HCV RNA due to reemergence of preexisting virus through Week 144 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 144 weeks
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Secondary outcome [2]
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Proportion of participants with detectable HCV resistance mutations through Week 144 by treatment regimen
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Assessment method [2]
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Timepoint [2]
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Up to 144 weeks
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Secondary outcome [3]
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Proportion of participants with detectable HCV RNA due to reinfection through Week 144 by treatment regimen
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Assessment method [3]
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0
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Timepoint [3]
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Up to 144 weeks
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Secondary outcome [4]
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Liver disease progression
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Assessment method [4]
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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 [4]
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Up to 144 weeks
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Secondary outcome [5]
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Proportion of participants who develop hepatocellular carcinoma (HCC) through Week 144 by treatment regimen
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Assessment method [5]
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0
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Timepoint [5]
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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 oral antiviral agent (OAV)
* Have achieved SVR in a Gilead-sponsored study, as defined in the original treatment protocol
* Provide written, informed consent
* Be willing and able to comply with the visit schedule and protocol-mandated procedures
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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
13/04/2012
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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
8/01/2018
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Sample size
Target
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Accrual to date
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Final
6625
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Recruitment in Australia
Recruitment state(s)
ACT,NSW,SA,VIC,WA
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Recruitment hospital [1]
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Canberra Specialist Centre - Canberra
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Royal Prince Alfred Hospital - Camperdown
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Concord Repatriation General Hospital - Concord
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East Sydney Doctors - Darlinghurst
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Holdsworth House Medical Practice - Darlinghurst
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St Vincent's Public Hospital Sydney - Darlinghurst
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St George Hospital - Kogarah
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Liverpool Hospital - Liverpool
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Westmead Hospital - Westmead
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Royal Adelaide Hospital - Adelaide
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Flinders University - Bedford Park
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Monash Medical Centre - Clayton
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St. Vincent's Hospital Melbourne - Fitzroy
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Footscray Hospital - Footscray
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Austin Health - Heidelberg
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Alfred Hospital - Melbourne
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The Royal Melbourne Hospital - Parkville
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Fremantle Hospital - Fremantle
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Recruitment hospital [19]
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Fiona Stanley Hospital - Murdoch
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Recruitment hospital [20]
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Greenslopes Private Hospital - Greenslopes
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Royal Brisbane & Women's Hospital - Herston
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Sir Charles Gairdner Hospital - Nedlands
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Royal Perth Hospital - Perth
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Recruitment hospital [24]
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Princess Alexandra Hospital - Woolloongabba
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- Canberra
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2050 - Camperdown
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2137 - Concord
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- Darlinghurst
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2217 - Kogarah
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2170 - Liverpool
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2145 - Westmead
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5000 - Adelaide
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5042 - Bedford Park
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3168 - Clayton
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3065 - Fitzroy
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3011 - Footscray
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Recruitment postcode(s) [13]
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3084 - Heidelberg
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3004 - Melbourne
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- Melbourne
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3050 - Parkville
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- Fremantle
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- Murdoch
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4102 - Greenslopes
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QLD 4029 - Herston
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6009 - Nedlands
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6001 - Perth
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Recruitment postcode(s) [23]
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4102 - Woolloongabba
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Recruitment outside Australia
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Illinois
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Indiana
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Auckland
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BAY OF Plenty
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Stockholm
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United Kingdom
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England
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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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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
This Registry is designed to provide long term clinical and virologic follow up in participants who have achieved sustained virologic response (SVR) while participating in a previous Gilead sponsored hepatitis C virus (HCV) study. This long term follow up study is observational and no treatment is provided for HCV.
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Trial website
https://clinicaltrials.gov/study/NCT01457755
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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.
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Public notes
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Contacts
Principal investigator
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Gilead Study Director
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Gilead Sciences
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Contact person for scientific queries
No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT01457755
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