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
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Sponsor:
Gilead Sciences
Information provided by (Responsible Party):
Gilead Sciences
Tracking Information | ||||
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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 |
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 |
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
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Change History | ||||
Current Secondary Outcome Measures |
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Original Secondary Outcome Measures |
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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 |
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Target Follow-Up Duration | Not Provided | |||
Biospecimen | Retention: Samples Without DNA Description: Plasma
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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 * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | ||||
Recruitment Status | Completed | |||
Actual Enrollment |
570 | |||
Original Estimated Enrollment |
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:
Key Exclusion Criteria:
Note: Other protocol defined Inclusion/Exclusion criteria may apply. |
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Sex/Gender |
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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 ) |
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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 |
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PRS Account | Gilead Sciences | |||
Verification Date | May 2018 |