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A Gilead Sequence Registry of Subjects Who Did Not Achieve Sustained Virologic Response

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ClinicalTrials.gov Identifier: NCT01457768
Recruitment Status : Completed
First Posted : October 24, 2011
Last Update Posted : May 4, 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 May 4, 2018
Actual Study Start Date December 19, 2011
Actual Primary Completion Date April 9, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: December 8, 2014)
Proportion of participants with at least one drug resistant mutation (DRM) loss from enrollment to end of study by treatment regimen [ Time Frame: Up to 3 years ]
Original Primary Outcome Measures
 (submitted: October 20, 2011)
Viral Activity [ Time Frame: 3 years ]
To characterize HCV viral sequences and the persistence or evolution of treatment emergent viral mutations in subjects who fail to achieve an SVR after treatment with a Gilead oral antiviral (OAV) containing regimen in a previous Gilead-sponsored hepatitis C study
Change History
Current Secondary Outcome Measures
 (submitted: December 8, 2014)
  • Proportion of participants with DRM loss by unit category, 1, 2, 3,…n, by treatment regimen [ Time Frame: Up to 3 years ]
  • Average number of DRM loss by treatment regimen [ Time Frame: Up to 3 years ]
  • Liver disease progression [ Time Frame: Up to 3 years ]
    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)
  • Clinical progression of liver disease [ Time Frame: 3 years ]
    Clinical progression of liver disease will be assessed 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 and 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 A Gilead Sequence Registry of Subjects Who Did Not Achieve Sustained Virologic Response
Official 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
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.
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 failed to achieve sustained virologic response (SVR) while receiving at least one Gilead OAV in a previous Gilead-sponsored HCV study.
Condition Hepatitis C, Chronic
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications *

*   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: May 13, 2017)
570
Original Estimated Enrollment
 (submitted: October 20, 2011)
600
Actual Study Completion Date April 9, 2018
Actual Primary Completion Date April 9, 2018   (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 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 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,   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 NCT01457768
Other Study ID Numbers GS-US-248-0123
2011-000946-39 ( EudraCT Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Gilead Sciences
Study Sponsor Gilead Sciences
Collaborators Not Provided
Investigators
Study Director: Gilead Study Director Gilead Sciences
PRS Account Gilead Sciences
Verification Date May 2018