Gilead Sustained Virologic Response (SVR) Registry

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
Gilead Sciences
ClinicalTrials.gov Identifier:
NCT01457755
First received: October 4, 2011
Last updated: June 21, 2016
Last verified: June 2016

October 4, 2011
June 21, 2016
April 2012
October 2020   (final data collection date for primary outcome measure)
Proportion of participants maintaining SVR at Week 144 by treatment regimen [ Time Frame: Week 144 ] [ Designated as safety issue: No ]
Sustained Virologic Response [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
To assess the durability of sustained virologic response (SVR) following treatment in a Gilead-sponsored hepatitis C study
Complete list of historical versions of study NCT01457755 on ClinicalTrials.gov Archive Site
  • Proportion of participants with detectable HCV RNA due to reemergence of preexisting virus through Week 144 by treatment regimen [ Time Frame: Up to 144 weeks ] [ Designated as safety issue: No ]
  • Proportion of participants with detectable HCV resistance mutations through Week 144 by treatment regimen [ Time Frame: Up to 144 weeks ] [ Designated as safety issue: No ]
  • Proportion of participants with detectable HCV RNA due to reinfection through Week 144 by treatment regimen [ Time Frame: Up to 144 weeks ] [ Designated as safety issue: No ]
  • Liver disease progression [ Time Frame: Up to 144 weeks ] [ Designated as safety issue: No ]
    Liver disease progression is a composite endpoint measured by laboratory parameters (alanine aminotransferase (ALT), aspartate aminotransferase (AST), bilirubin, albumin, platelets, prothrombin time (PT) and α-fetoprotein) and observed or reported clinical signs and symptoms.
  • Proportion of participants who develop hepatocellular carcinoma (HCC) through Week 144 by treatment regimen [ Time Frame: Up to 144 weeks ] [ Designated as safety issue: No ]
  • Subsequent detection of HCV RNA [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
    To determine whether subsequent detection of HCV RNA in subjects who relapse following SVR, represents the re emergence of pre-existing virus, the development of resistance mutations, or whether it is due to re-infection
  • Clinical Progression of liver disease [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
    Clinical progression of liver disease will be assesssed by review of clinical signs, symptoms and laboratory parameters (clinical chemistry, haematology, coagulation and alfa-feto protein).
  • Development of hepatocellular carcinoma (HCC) [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
    Screening for the development of HCC will comprise of review of clinical signs, symptoms and laboratory parameters including alfa-feto protein.
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Gilead Sustained Virologic Response (SVR) Registry
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
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.
Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
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Retention:   Samples Without DNA
Description:
Plasma
Non-Probability Sample
Participants who have achieved sustained virologic response (SVR) while participating in a previous Gilead sponsored HCV study.
Hepatitis C, Chronic
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Enrolling by invitation
7000
October 2020
October 2020   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • 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

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
Both
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States,   Australia,   Austria,   Belgium,   Canada,   Czech Republic,   Estonia,   France,   Germany,   Italy,   Netherlands,   New Zealand,   Poland,   Puerto Rico,   Spain,   Sweden,   United Kingdom
 
NCT01457755
GS-US-248-0122, 2011-000945-19
No
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Gilead Sciences
Gilead Sciences
Not Provided
Study Director: Theo Brandt-Sarif, MD Gilead Sciences
Gilead Sciences
June 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP