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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
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
Trial website
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

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