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Gilead Sustained Virologic Response (SVR) Registry

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01457755
Recruitment Status : Completed
First Posted : October 24, 2011
Last Update Posted : August 31, 2018
Sponsor:
Information provided by (Responsible Party):
Gilead Sciences

Tracking Information
First Submitted Date October 4, 2011
First Posted Date October 24, 2011
Last Update Posted Date August 31, 2018
Actual Study Start Date April 13, 2012
Actual Primary Completion Date March 28, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: December 8, 2014)		 Proportion of participants maintaining SVR at Week 144 by treatment regimen [ Time Frame: Week 144 ]
Original Primary Outcome Measures
 (submitted: October 20, 2011)		 Sustained Virologic Response [ Time Frame: 3 years ]
To assess the durability of sustained virologic response (SVR) following treatment in a Gilead-sponsored hepatitis C study
Change History
Current Secondary Outcome Measures
 (submitted: December 8, 2014)
  • 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 ]
  • Proportion of participants with detectable HCV resistance mutations through Week 144 by treatment regimen [ Time Frame: Up to 144 weeks ]
  • Proportion of participants with detectable HCV RNA due to reinfection through Week 144 by treatment regimen [ Time Frame: Up to 144 weeks ]
  • Liver disease progression [ Time Frame: Up to 144 weeks ]
    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 ]
Original Secondary Outcome Measures
 (submitted: October 20, 2011)
  • Subsequent detection of HCV RNA [ Time Frame: 3 years ]
    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 ]
    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 ]
    Screening for the development of HCC will comprise of review of clinical signs, symptoms and laboratory parameters including alfa-feto protein.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Gilead Sustained Virologic Response (SVR) Registry
Official 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
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.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples Without DNA
Description:
Plasma
Sampling Method Non-Probability Sample
Study Population Participants who have achieved sustained virologic response (SVR) while participating in a previous Gilead sponsored HCV study.
Condition Hepatitis C, Chronic
Intervention Not Provided
Study Groups/Cohorts Not Provided
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: December 8, 2017)		 6625
Original Estimated Enrollment
 (submitted: October 20, 2011)		 600
Actual Study Completion Date January 8, 2018
Actual Primary Completion Date March 28, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria

Key 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

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.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Australia,   Austria,   Belgium,   Canada,   Czechia,   Estonia,   France,   Germany,   Italy,   Netherlands,   New Zealand,   Poland,   Puerto Rico,   Spain,   Sweden,   United Kingdom,   United States
Removed Location Countries Czech Republic
 
Administrative Information
NCT Number NCT01457755
Other Study ID Numbers GS-US-248-0122
2011-000945-19 ( EudraCT Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Current Responsible Party Gilead Sciences
Original Responsible Party Same as current
Current Study Sponsor Gilead Sciences
Original Study Sponsor Same as current
Collaborators Not Provided
Investigators
Study Director: Gilead Study Director Gilead Sciences
PRS Account Gilead Sciences
Verification Date August 2018