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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/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
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
Secondary ID [1] 0 0
2011-000946-39
Secondary ID [2] 0 0
GS-US-248-0123
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hepatitis C, Chronic 0 0
Condition category
Condition code
Infection 0 0 0 0
Other infectious diseases
Oral and Gastrointestinal 0 0 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Proportion of participants with at least one drug resistant mutation (DRM) loss from enrollment to end of study by treatment regimen
Timepoint [1] 0 0
Up to 3 years
Secondary outcome [1] 0 0
Proportion of participants with DRM loss by unit category, 1, 2, 3,…n, by treatment regimen
Timepoint [1] 0 0
Up to 3 years
Secondary outcome [2] 0 0
Average number of DRM loss by treatment regimen
Timepoint [2] 0 0
Up to 3 years
Secondary outcome [3] 0 0
Liver disease progression
Timepoint [3] 0 0
Up to 3 years
Secondary outcome [4] 0 0
Proportion of participants who develop hepatocellular carcinoma (HCC) through Week 144 by treatment regimen
Timepoint [4] 0 0
Up to 144 weeks

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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
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.

Study design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
19/12/2011
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
9/04/2018
Sample size
Target
Accrual to date
Final
570
Recruitment in Australia
Recruitment state(s)
ACT,NSW,QLD,SA,VIC,WA
Recruitment hospital [1] 0 0
Canberra Specialist Centre - Canberra
Recruitment hospital [2] 0 0
Royal Prince Alfred Hospital - Camperdown
Recruitment hospital [3] 0 0
102 Burton Street - Darlinghurst
Recruitment hospital [4] 0 0
East Sydney Doctors - Darlinghurst
Recruitment hospital [5] 0 0
St Vincent's Public Hospital Sydney - Darlinghurst
Recruitment hospital [6] 0 0
Liverpool Hospital - Liverpool
Recruitment hospital [7] 0 0
Westmead Hospital - Westmead
Recruitment hospital [8] 0 0
Greenslopes Private Hospital - Woolloongabba
Recruitment hospital [9] 0 0
Flinders Medical Centre - Bedford Park
Recruitment hospital [10] 0 0
Footscray Hospital - Footscray
Recruitment hospital [11] 0 0
Austin Health - Heidelberg
Recruitment hospital [12] 0 0
Alfred Hospital - Infectious Disease Unit - Melbourne
Recruitment hospital [13] 0 0
Alfred Hospital - Melbourne
Recruitment hospital [14] 0 0
Monash Medical Centre - Melbourne
Recruitment hospital [15] 0 0
Fiona Stanley Hospital - Murdoch
Recruitment hospital [16] 0 0
Royal Perth Hospital - Perth
Recruitment hospital [17] 0 0
St Vincent's University Hospital - Fitzroy
Recruitment hospital [18] 0 0
Royal Brisbane & Women's Hospital - QLD
Recruitment hospital [19] 0 0
Princess Alexandra Hospital - Woolloongabba
Recruitment postcode(s) [1] 0 0
- Canberra
Recruitment postcode(s) [2] 0 0
2050 - Camperdown
Recruitment postcode(s) [3] 0 0
2010 - Darlinghurst
Recruitment postcode(s) [4] 0 0
- Darlinghurst
Recruitment postcode(s) [5] 0 0
2170 - Liverpool
Recruitment postcode(s) [6] 0 0
2145 - Westmead
Recruitment postcode(s) [7] 0 0
4102 - Woolloongabba
Recruitment postcode(s) [8] 0 0
5042 - Bedford Park
Recruitment postcode(s) [9] 0 0
- Footscray
Recruitment postcode(s) [10] 0 0
- Heidelberg
Recruitment postcode(s) [11] 0 0
3004 - Melbourne
Recruitment postcode(s) [12] 0 0
3168 - Melbourne
Recruitment postcode(s) [13] 0 0
- Murdoch
Recruitment postcode(s) [14] 0 0
6000 - Perth
Recruitment postcode(s) [15] 0 0
3065 - Fitzroy
Recruitment postcode(s) [16] 0 0
4029 - QLD
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
Arizona
Country [3] 0 0
United States of America
State/province [3] 0 0
California
Country [4] 0 0
United States of America
State/province [4] 0 0
Colorado
Country [5] 0 0
United States of America
State/province [5] 0 0
Connecticut
Country [6] 0 0
United States of America
State/province [6] 0 0
District of Columbia
Country [7] 0 0
United States of America
State/province [7] 0 0
Florida
Country [8] 0 0
United States of America
State/province [8] 0 0
Georgia
Country [9] 0 0
United States of America
State/province [9] 0 0
Illinois
Country [10] 0 0
United States of America
State/province [10] 0 0
Indiana
Country [11] 0 0
United States of America
State/province [11] 0 0
Kansas
Country [12] 0 0
United States of America
State/province [12] 0 0
Kentucky
Country [13] 0 0
United States of America
State/province [13] 0 0
Louisiana
Country [14] 0 0
United States of America
State/province [14] 0 0
Maryland
Country [15] 0 0
United States of America
State/province [15] 0 0
Massachusetts
Country [16] 0 0
United States of America
State/province [16] 0 0
Michigan
Country [17] 0 0
United States of America
State/province [17] 0 0
Minnesota
Country [18] 0 0
United States of America
State/province [18] 0 0
Mississippi
Country [19] 0 0
United States of America
State/province [19] 0 0
Missouri
Country [20] 0 0
United States of America
State/province [20] 0 0
Nevada
Country [21] 0 0
United States of America
State/province [21] 0 0
New Jersey
Country [22] 0 0
United States of America
State/province [22] 0 0
New Mexico
Country [23] 0 0
United States of America
State/province [23] 0 0
New York
Country [24] 0 0
United States of America
State/province [24] 0 0
North Carolina
Country [25] 0 0
United States of America
State/province [25] 0 0
Oklahoma
Country [26] 0 0
United States of America
State/province [26] 0 0
Oregon
Country [27] 0 0
United States of America
State/province [27] 0 0
Pennsylvania
Country [28] 0 0
United States of America
State/province [28] 0 0
Rhode Island
Country [29] 0 0
United States of America
State/province [29] 0 0
Tennessee
Country [30] 0 0
United States of America
State/province [30] 0 0
Texas
Country [31] 0 0
United States of America
State/province [31] 0 0
Utah
Country [32] 0 0
United States of America
State/province [32] 0 0
Virginia
Country [33] 0 0
United States of America
State/province [33] 0 0
Washington
Country [34] 0 0
United States of America
State/province [34] 0 0
Wisconsin
Country [35] 0 0
Austria
State/province [35] 0 0
Styria
Country [36] 0 0
Austria
State/province [36] 0 0
Vienna
Country [37] 0 0
Canada
State/province [37] 0 0
British Columbia
Country [38] 0 0
Canada
State/province [38] 0 0
Ontario
Country [39] 0 0
Canada
State/province [39] 0 0
Calgary
Country [40] 0 0
Canada
State/province [40] 0 0
Edmonton
Country [41] 0 0
Canada
State/province [41] 0 0
Montreal
Country [42] 0 0
Canada
State/province [42] 0 0
Toronto
Country [43] 0 0
Canada
State/province [43] 0 0
Vancouver
Country [44] 0 0
Canada
State/province [44] 0 0
Winnipeg
Country [45] 0 0
Czechia
State/province [45] 0 0
Praha 4
Country [46] 0 0
Czechia
State/province [46] 0 0
Praha 6
Country [47] 0 0
Estonia
State/province [47] 0 0
Talinn
Country [48] 0 0
Estonia
State/province [48] 0 0
Tartu
Country [49] 0 0
France
State/province [49] 0 0
Aquitaine
Country [50] 0 0
France
State/province [50] 0 0
Auvergne
Country [51] 0 0
France
State/province [51] 0 0
Ile-de-france
Country [52] 0 0
France
State/province [52] 0 0
NORD Pas-de-calais
Country [53] 0 0
France
State/province [53] 0 0
Provence Alpes COTE D'azur
Country [54] 0 0
France
State/province [54] 0 0
Rhone-alpes
Country [55] 0 0
France
State/province [55] 0 0
clichy Cedex
Country [56] 0 0
France
State/province [56] 0 0
Montpellier
Country [57] 0 0
France
State/province [57] 0 0
Nice cedex 3
Country [58] 0 0
France
State/province [58] 0 0
Paris
Country [59] 0 0
France
State/province [59] 0 0
Rennes Cedex 9
Country [60] 0 0
France
State/province [60] 0 0
Strasbourg
Country [61] 0 0
France
State/province [61] 0 0
Vandoeuvre
Country [62] 0 0
Germany
State/province [62] 0 0
Baden-wuerttemberg
Country [63] 0 0
Germany
State/province [63] 0 0
Hessen
Country [64] 0 0
Germany
State/province [64] 0 0
Niedersachsen
Country [65] 0 0
Germany
State/province [65] 0 0
Nordrhein-westfalen
Country [66] 0 0
Germany
State/province [66] 0 0
Berlin
Country [67] 0 0
Germany
State/province [67] 0 0
Bonn
Country [68] 0 0
Germany
State/province [68] 0 0
Dusseldorf
Country [69] 0 0
Germany
State/province [69] 0 0
Frankfurt
Country [70] 0 0
Germany
State/province [70] 0 0
Freiburg
Country [71] 0 0
Germany
State/province [71] 0 0
Hamburg
Country [72] 0 0
Germany
State/province [72] 0 0
Hannover
Country [73] 0 0
Germany
State/province [73] 0 0
Heidelberg
Country [74] 0 0
Germany
State/province [74] 0 0
Kiel
Country [75] 0 0
Germany
State/province [75] 0 0
Leipzig
Country [76] 0 0
Germany
State/province [76] 0 0
Mainz
Country [77] 0 0
Germany
State/province [77] 0 0
Muenchen
Country [78] 0 0
Germany
State/province [78] 0 0
Wurzburg
Country [79] 0 0
Germany
State/province [79] 0 0
Wüerzburg
Country [80] 0 0
Italy
State/province [80] 0 0
Foggia
Country [81] 0 0
Italy
State/province [81] 0 0
Bergamo
Country [82] 0 0
Italy
State/province [82] 0 0
Bologna
Country [83] 0 0
Italy
State/province [83] 0 0
Genova
Country [84] 0 0
Italy
State/province [84] 0 0
Milano
Country [85] 0 0
Italy
State/province [85] 0 0
Padova
Country [86] 0 0
Italy
State/province [86] 0 0
Palermo
Country [87] 0 0
Italy
State/province [87] 0 0
Parma
Country [88] 0 0
Italy
State/province [88] 0 0
Roma
Country [89] 0 0
Italy
State/province [89] 0 0
Torino
Country [90] 0 0
Netherlands
State/province [90] 0 0
Noord-holland
Country [91] 0 0
Netherlands
State/province [91] 0 0
Zuid-holland
Country [92] 0 0
Netherlands
State/province [92] 0 0
Nijmegen
Country [93] 0 0
New Zealand
State/province [93] 0 0
Auckland
Country [94] 0 0
New Zealand
State/province [94] 0 0
BAY OF Plenty
Country [95] 0 0
New Zealand
State/province [95] 0 0
WGN
Country [96] 0 0
New Zealand
State/province [96] 0 0
Christchurch
Country [97] 0 0
New Zealand
State/province [97] 0 0
Hamilton
Country [98] 0 0
New Zealand
State/province [98] 0 0
Wellington
Country [99] 0 0
Poland
State/province [99] 0 0
Dolnoslaskie
Country [100] 0 0
Poland
State/province [100] 0 0
Mazowieckie
Country [101] 0 0
Poland
State/province [101] 0 0
Podlaskie
Country [102] 0 0
Poland
State/province [102] 0 0
Slaskie
Country [103] 0 0
Poland
State/province [103] 0 0
Chorzow
Country [104] 0 0
Poland
State/province [104] 0 0
Lodz
Country [105] 0 0
Poland
State/province [105] 0 0
Myslowice
Country [106] 0 0
Puerto Rico
State/province [106] 0 0
San Juan
Country [107] 0 0
Spain
State/province [107] 0 0
Madrid
Country [108] 0 0
Spain
State/province [108] 0 0
Barcelona
Country [109] 0 0
Spain
State/province [109] 0 0
Sevilla
Country [110] 0 0
Spain
State/province [110] 0 0
Valencia
Country [111] 0 0
Sweden
State/province [111] 0 0
Vastra Gotaland
Country [112] 0 0
Sweden
State/province [112] 0 0
Göteborg
Country [113] 0 0
Sweden
State/province [113] 0 0
Lund
Country [114] 0 0
Sweden
State/province [114] 0 0
Malmö
Country [115] 0 0
Sweden
State/province [115] 0 0
Solna
Country [116] 0 0
United Kingdom
State/province [116] 0 0
England
Country [117] 0 0
United Kingdom
State/province [117] 0 0
Bristol
Country [118] 0 0
United Kingdom
State/province [118] 0 0
Plymouth

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

Ethics approval
Ethics application status

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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT01457768
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Gilead Study Director
Address 0 0
Gilead Sciences
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