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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/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
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
Secondary ID [1] 0 0
2011-000945-19
Secondary ID [2] 0 0
GS-US-248-0122
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 maintaining SVR at Week 144 by treatment regimen
Timepoint [1] 0 0
Week 144
Secondary outcome [1] 0 0
Proportion of participants with detectable HCV RNA due to reemergence of preexisting virus through Week 144 by treatment regimen
Timepoint [1] 0 0
Up to 144 weeks
Secondary outcome [2] 0 0
Proportion of participants with detectable HCV resistance mutations through Week 144 by treatment regimen
Timepoint [2] 0 0
Up to 144 weeks
Secondary outcome [3] 0 0
Proportion of participants with detectable HCV RNA due to reinfection through Week 144 by treatment regimen
Timepoint [3] 0 0
Up to 144 weeks
Secondary outcome [4] 0 0
Liver disease progression
Timepoint [4] 0 0
Up to 144 weeks
Secondary outcome [5] 0 0
Proportion of participants who develop hepatocellular carcinoma (HCC) through Week 144 by treatment regimen
Timepoint [5] 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 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

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
13/04/2012
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
8/01/2018
Sample size
Target
Accrual to date
Final
6625
Recruitment in Australia
Recruitment state(s)
ACT,NSW,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
Concord Repatriation General Hospital - Concord
Recruitment hospital [4] 0 0
East Sydney Doctors - Darlinghurst
Recruitment hospital [5] 0 0
Holdsworth House Medical Practice - Darlinghurst
Recruitment hospital [6] 0 0
St Vincent's Public Hospital Sydney - Darlinghurst
Recruitment hospital [7] 0 0
St George Hospital - Kogarah
Recruitment hospital [8] 0 0
Liverpool Hospital - Liverpool
Recruitment hospital [9] 0 0
Westmead Hospital - Westmead
Recruitment hospital [10] 0 0
Royal Adelaide Hospital - Adelaide
Recruitment hospital [11] 0 0
Flinders University - Bedford Park
Recruitment hospital [12] 0 0
Monash Medical Centre - Clayton
Recruitment hospital [13] 0 0
St. Vincent's Hospital Melbourne - Fitzroy
Recruitment hospital [14] 0 0
Footscray Hospital - Footscray
Recruitment hospital [15] 0 0
Austin Health - Heidelberg
Recruitment hospital [16] 0 0
Alfred Hospital - Melbourne
Recruitment hospital [17] 0 0
The Royal Melbourne Hospital - Parkville
Recruitment hospital [18] 0 0
Fremantle Hospital - Fremantle
Recruitment hospital [19] 0 0
Fiona Stanley Hospital - Murdoch
Recruitment hospital [20] 0 0
Greenslopes Private Hospital - Greenslopes
Recruitment hospital [21] 0 0
Royal Brisbane & Women's Hospital - Herston
Recruitment hospital [22] 0 0
Sir Charles Gairdner Hospital - Nedlands
Recruitment hospital [23] 0 0
Royal Perth Hospital - Perth
Recruitment hospital [24] 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
2137 - Concord
Recruitment postcode(s) [4] 0 0
- Darlinghurst
Recruitment postcode(s) [5] 0 0
2217 - Kogarah
Recruitment postcode(s) [6] 0 0
2170 - Liverpool
Recruitment postcode(s) [7] 0 0
2145 - Westmead
Recruitment postcode(s) [8] 0 0
5000 - Adelaide
Recruitment postcode(s) [9] 0 0
5042 - Bedford Park
Recruitment postcode(s) [10] 0 0
3168 - Clayton
Recruitment postcode(s) [11] 0 0
3065 - Fitzroy
Recruitment postcode(s) [12] 0 0
3011 - Footscray
Recruitment postcode(s) [13] 0 0
3084 - Heidelberg
Recruitment postcode(s) [14] 0 0
3004 - Melbourne
Recruitment postcode(s) [15] 0 0
- Melbourne
Recruitment postcode(s) [16] 0 0
3050 - Parkville
Recruitment postcode(s) [17] 0 0
- Fremantle
Recruitment postcode(s) [18] 0 0
- Murdoch
Recruitment postcode(s) [19] 0 0
4102 - Greenslopes
Recruitment postcode(s) [20] 0 0
QLD 4029 - Herston
Recruitment postcode(s) [21] 0 0
6009 - Nedlands
Recruitment postcode(s) [22] 0 0
6001 - Perth
Recruitment postcode(s) [23] 0 0
4102 - Woolloongabba
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
Hawaii
Country [10] 0 0
United States of America
State/province [10] 0 0
Illinois
Country [11] 0 0
United States of America
State/province [11] 0 0
Indiana
Country [12] 0 0
United States of America
State/province [12] 0 0
Kansas
Country [13] 0 0
United States of America
State/province [13] 0 0
Kentucky
Country [14] 0 0
United States of America
State/province [14] 0 0
Louisiana
Country [15] 0 0
United States of America
State/province [15] 0 0
Maryland
Country [16] 0 0
United States of America
State/province [16] 0 0
Massachusetts
Country [17] 0 0
United States of America
State/province [17] 0 0
Michigan
Country [18] 0 0
United States of America
State/province [18] 0 0
Minnesota
Country [19] 0 0
United States of America
State/province [19] 0 0
Mississippi
Country [20] 0 0
United States of America
State/province [20] 0 0
Missouri
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
Ohio
Country [26] 0 0
United States of America
State/province [26] 0 0
Oklahoma
Country [27] 0 0
United States of America
State/province [27] 0 0
Oregon
Country [28] 0 0
United States of America
State/province [28] 0 0
Pennsylvania
Country [29] 0 0
United States of America
State/province [29] 0 0
Rhode Island
Country [30] 0 0
United States of America
State/province [30] 0 0
Tennessee
Country [31] 0 0
United States of America
State/province [31] 0 0
Texas
Country [32] 0 0
United States of America
State/province [32] 0 0
Utah
Country [33] 0 0
United States of America
State/province [33] 0 0
Virginia
Country [34] 0 0
United States of America
State/province [34] 0 0
Washington
Country [35] 0 0
United States of America
State/province [35] 0 0
Wisconsin
Country [36] 0 0
Austria
State/province [36] 0 0
Styria
Country [37] 0 0
Austria
State/province [37] 0 0
Vienna
Country [38] 0 0
Belgium
State/province [38] 0 0
Antwerpen
Country [39] 0 0
Belgium
State/province [39] 0 0
Brussels
Country [40] 0 0
Belgium
State/province [40] 0 0
Kortrijk
Country [41] 0 0
Canada
State/province [41] 0 0
Alberta
Country [42] 0 0
Canada
State/province [42] 0 0
British Columbia
Country [43] 0 0
Canada
State/province [43] 0 0
Manitoba
Country [44] 0 0
Canada
State/province [44] 0 0
Ontario
Country [45] 0 0
Canada
State/province [45] 0 0
Quebec
Country [46] 0 0
Czechia
State/province [46] 0 0
Opava
Country [47] 0 0
Czechia
State/province [47] 0 0
Praha 4
Country [48] 0 0
Czechia
State/province [48] 0 0
Praha 6
Country [49] 0 0
Estonia
State/province [49] 0 0
Talinn
Country [50] 0 0
Estonia
State/province [50] 0 0
Tartu
Country [51] 0 0
France
State/province [51] 0 0
Auvergne
Country [52] 0 0
France
State/province [52] 0 0
Ile-de-france
Country [53] 0 0
France
State/province [53] 0 0
Limousin, Lorraine
Country [54] 0 0
France
State/province [54] 0 0
Limousin
Country [55] 0 0
France
State/province [55] 0 0
Midi-pyrenees
Country [56] 0 0
France
State/province [56] 0 0
NORD Pas-de-calais
Country [57] 0 0
France
State/province [57] 0 0
Provence Alpes COTE D'azur
Country [58] 0 0
France
State/province [58] 0 0
Rhone-alpes
Country [59] 0 0
France
State/province [59] 0 0
Clichy Cedex
Country [60] 0 0
France
State/province [60] 0 0
Montpellier
Country [61] 0 0
France
State/province [61] 0 0
Nice cedex 3
Country [62] 0 0
France
State/province [62] 0 0
Paris, Cedex 14
Country [63] 0 0
France
State/province [63] 0 0
Paris
Country [64] 0 0
France
State/province [64] 0 0
Pessac Cedex
Country [65] 0 0
France
State/province [65] 0 0
Rennes Cedex 9
Country [66] 0 0
France
State/province [66] 0 0
Strasbourg
Country [67] 0 0
Germany
State/province [67] 0 0
Baden-wuerttemberg
Country [68] 0 0
Germany
State/province [68] 0 0
Bayern
Country [69] 0 0
Germany
State/province [69] 0 0
Hessen
Country [70] 0 0
Germany
State/province [70] 0 0
Nordrhein-westfalen
Country [71] 0 0
Germany
State/province [71] 0 0
Berlin
Country [72] 0 0
Germany
State/province [72] 0 0
Bonn
Country [73] 0 0
Germany
State/province [73] 0 0
Frankfurt
Country [74] 0 0
Germany
State/province [74] 0 0
Hamburg
Country [75] 0 0
Germany
State/province [75] 0 0
Hannover
Country [76] 0 0
Germany
State/province [76] 0 0
Kiel
Country [77] 0 0
Germany
State/province [77] 0 0
Leipzig
Country [78] 0 0
Germany
State/province [78] 0 0
Mainz
Country [79] 0 0
Italy
State/province [79] 0 0
Foggia
Country [80] 0 0
Italy
State/province [80] 0 0
Bergamo
Country [81] 0 0
Italy
State/province [81] 0 0
Bologna
Country [82] 0 0
Italy
State/province [82] 0 0
Genova
Country [83] 0 0
Italy
State/province [83] 0 0
Milano
Country [84] 0 0
Italy
State/province [84] 0 0
Padova
Country [85] 0 0
Italy
State/province [85] 0 0
Palermo
Country [86] 0 0
Italy
State/province [86] 0 0
Parma
Country [87] 0 0
Italy
State/province [87] 0 0
Roma
Country [88] 0 0
Italy
State/province [88] 0 0
Torino
Country [89] 0 0
Netherlands
State/province [89] 0 0
Noord-holland
Country [90] 0 0
Netherlands
State/province [90] 0 0
Zuid-holland
Country [91] 0 0
Netherlands
State/province [91] 0 0
Nijmegen
Country [92] 0 0
New Zealand
State/province [92] 0 0
Auckland
Country [93] 0 0
New Zealand
State/province [93] 0 0
BAY OF Plenty
Country [94] 0 0
New Zealand
State/province [94] 0 0
WGN
Country [95] 0 0
New Zealand
State/province [95] 0 0
Christchurch
Country [96] 0 0
New Zealand
State/province [96] 0 0
Dunedin
Country [97] 0 0
New Zealand
State/province [97] 0 0
Hamilton
Country [98] 0 0
Poland
State/province [98] 0 0
Dolnoslaskie
Country [99] 0 0
Poland
State/province [99] 0 0
Mazowieckie
Country [100] 0 0
Poland
State/province [100] 0 0
Podlaskie
Country [101] 0 0
Poland
State/province [101] 0 0
Slaskie
Country [102] 0 0
Poland
State/province [102] 0 0
Lodz
Country [103] 0 0
Puerto Rico
State/province [103] 0 0
San Juan
Country [104] 0 0
Spain
State/province [104] 0 0
Madrid
Country [105] 0 0
Spain
State/province [105] 0 0
Malaga
Country [106] 0 0
Spain
State/province [106] 0 0
Barcelona
Country [107] 0 0
Spain
State/province [107] 0 0
Santander
Country [108] 0 0
Spain
State/province [108] 0 0
Sevilla
Country [109] 0 0
Spain
State/province [109] 0 0
Valencia
Country [110] 0 0
Sweden
State/province [110] 0 0
Göteborg
Country [111] 0 0
Sweden
State/province [111] 0 0
Lund
Country [112] 0 0
Sweden
State/province [112] 0 0
Malmö
Country [113] 0 0
Sweden
State/province [113] 0 0
Stockholm
Country [114] 0 0
United Kingdom
State/province [114] 0 0
England

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 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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT01457755
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



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT01457755