Sofosbuvir + Ribavirin for 12 or 16 Weeks in Treatment Experienced Subjects With Chronic Genotype 2 or 3 HCV Infection (FUSION) (FUSION)
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ClinicalTrials.gov Identifier: NCT01604850 |
Recruitment Status :
Completed
First Posted : May 24, 2012
Results First Posted : May 1, 2014
Last Update Posted : May 28, 2014
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Sponsor:
Gilead Sciences
Information provided by (Responsible Party):
Gilead Sciences
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Tracking Information | |||
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First Submitted Date ICMJE | May 21, 2012 | ||
First Posted Date ICMJE | May 24, 2012 | ||
Results First Submitted Date ICMJE | March 31, 2014 | ||
Results First Posted Date ICMJE | May 1, 2014 | ||
Last Update Posted Date | May 28, 2014 | ||
Study Start Date ICMJE | June 2012 | ||
Actual Primary Completion Date | February 2013 (Final data collection date for primary outcome measure) | ||
Current Primary Outcome Measures ICMJE |
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Original Primary Outcome Measures ICMJE |
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Change History | |||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE |
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Current Other Pre-specified Outcome Measures | Not Provided | ||
Original Other Pre-specified Outcome Measures | Not Provided | ||
Descriptive Information | |||
Brief Title ICMJE | Sofosbuvir + Ribavirin for 12 or 16 Weeks in Treatment Experienced Subjects With Chronic Genotype 2 or 3 HCV Infection (FUSION) | ||
Official Title ICMJE | A Phase 3, Multicenter, Randomized, Double-Blind, Study to Investigate the Efficacy and Safety of GS-7977 + Ribavirin for 12 or 16 Weeks in Treatment Experienced Subjects With Chronic Genotype 2 or 3 HCV Infection | ||
Brief Summary | This study was to assess the safety and efficacy of sofosbuvir in combination with ribavirin (RBV) administered for 12 or 16 weeks in participants with genotypes 2 or 3 hepatitis C virus (HCV) infection as assessed by the proportion of participants with sustained virologic response (SVR) 12 weeks after discontinuation of therapy (SVR12). | ||
Detailed Description | Not Provided | ||
Study Type ICMJE | Interventional | ||
Study Phase ICMJE | Phase 3 | ||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
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Condition ICMJE | Chronic Hepatitis C | ||
Intervention ICMJE |
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Study Arms ICMJE |
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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 ICMJE | Completed | ||
Actual Enrollment ICMJE |
202 | ||
Original Estimated Enrollment ICMJE |
200 | ||
Actual Study Completion Date ICMJE | May 2013 | ||
Actual Primary Completion Date | February 2013 (Final data collection date for primary outcome measure) | ||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||
Accepts Healthy Volunteers ICMJE | No | ||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||
Listed Location Countries ICMJE | Canada, New Zealand, Puerto Rico, United States | ||
Removed Location Countries | |||
Administrative Information | |||
NCT Number ICMJE | NCT01604850 | ||
Other Study ID Numbers ICMJE | GS-US-334-0108 | ||
Has Data Monitoring Committee | Yes | ||
U.S. FDA-regulated Product | Not Provided | ||
IPD Sharing Statement ICMJE | Not Provided | ||
Responsible Party | Gilead Sciences | ||
Study Sponsor ICMJE | Gilead Sciences | ||
Collaborators ICMJE | Not Provided | ||
Investigators ICMJE | Not Provided | ||
PRS Account | Gilead Sciences | ||
Verification Date | May 2014 | ||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |