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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT01604850
Registration number
NCT01604850
Ethics application status
Date submitted
21/05/2012
Date registered
24/05/2012
Date last updated
28/05/2014
Titles & IDs
Public title
Sofosbuvir + Ribavirin for 12 or 16 Weeks in Treatment Experienced Subjects With Chronic Genotype 2 or 3 HCV Infection (FUSION)
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Scientific title
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
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Secondary ID [1]
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GS-US-334-0108
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Universal Trial Number (UTN)
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Trial acronym
FUSION
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Chronic Hepatitis C
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Condition category
Condition code
Infection
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Other infectious diseases
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Oral and Gastrointestinal
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Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - SOF
Treatment: Drugs - RBV
Treatment: Drugs - Placebo to match SOF
Treatment: Drugs - Placebo to match RBV
Experimental: SOF+RBV+placebo - Participants were randomized to receive SOF+RBV for 12 weeks followed by placebo to match SOF plus placebo to match RBV for 4 weeks.
Experimental: SOF+RBV - Participants were randomized to receive SOF+RBV for 16 weeks.
Treatment: Drugs: SOF
Sofosbuvir (SOF) 400 mg tablet was administered orally once daily.
Treatment: Drugs: RBV
Ribavirin (RBV) tablets was administered orally in a divided daily dose according to package insert weight-based dosing recommendations (< 75kg = 1000 mg and = 75 kg = 1200 mg).
Treatment: Drugs: Placebo to match SOF
Placebo to match SOF was administered orally once daily.
Treatment: Drugs: Placebo to match RBV
Placebo to match RBV was administered orally twice daily.
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Percentage of Participants Achieving SVR12
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Assessment method [1]
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SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ, ie, < 25 IU/mL) 12 weeks after cessation of therapy.
For the purposes of this efficacy analysis, the posttreatment period began after the end of active treatment (following Week 12 for the SOF+RBV+placebo arm, and Week 16 for the SOF+RBV arm).
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Timepoint [1]
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Posttreatment Week 12
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Primary outcome [2]
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Adverse Events Leading to Permanent Discontinuation of Study Drug
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Assessment method [2]
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Adverse events which led to permanent discontinuation of study drug may or may not have been related to study treatment.
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Timepoint [2]
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Baseline to Week 16
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Secondary outcome [1]
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Percentage of Participants Achieving SVR4
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Assessment method [1]
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SVR4 was defined as HCV RNA < LLOQ 4 weeks after cessation of therapy.
For the purposes of this efficacy analysis, the posttreatment period began after the end of active treatment (following Week 12 for the SOF+RBV+placebo arm, and Week 16 for the SOF+RBV arm).
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Timepoint [1]
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Posttreatment Week 4
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Secondary outcome [2]
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Percentage of Participants Achieving SVR24
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Assessment method [2]
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SVR24 was defined as HCV RNA < LLOQ 24 weeks after cessation of therapy.
For the purposes of this efficacy analysis, the posttreatment period began after the end of active treatment (following Week 12 for the SOF+RBV+placebo arm, and Week 16 for the SOF+RBV arm).
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Timepoint [2]
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Posttreatment Week 24
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Secondary outcome [3]
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Percentage of Participants With Viral Breakthrough
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Assessment method [3]
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Viral breakthrough was defined as HCV RNA = LLOQ after having previously had HCV RNA < LLOQ while receiving treatment, confirmed with 2 consecutive values (second confirmation value could be posttreatment), or last available on-treatment measurement with no subsequent follow-up values.
For the purposes of this efficacy analysis, assessments were made during active treatment (up to Week 12 for the SOF+RBV+placebo arm, and Week 16 for the SOF+RBV arm).
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Timepoint [3]
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Up to 16 weeks
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Secondary outcome [4]
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Percentage of Participants With Viral Relapse
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Assessment method [4]
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Viral relapse was defined as HCV RNA = LLOQ during the posttreatment period having achieved HCV RNA < LLOQ at end of treatment, confirmed with 2 consecutive values or last available posttreatment measurement.
For the purposes of this efficacy analysis, the posttreatment period began after the end of active treatment (following Week 12 for the SOF+RBV+placebo arm, and Week 16 for the SOF+RBV arm).
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Timepoint [4]
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End of treatment to posttreatment Week 24
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Eligibility
Key inclusion criteria
- Infection with HCV genotype 2 or 3
- Had cirrhosis determination
- Prior treatment failure
- Screening laboratory values within defined thresholds
- Subject had not been treated with any investigational drug or device within 30 days of
the screening visit
- Use of highly effective contraception methods if female of childbearing potential or
sexually active male
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
- Prior exposure to an direct-acting antiviral targeting the HCV nonstructural protein
(NS)5B polymerase
- Pregnant or nursing female or male with pregnant female partner
- Current or prior history of clinical hepatic decompensation
- History of clinically significant illness or any other major medical disorder that may
have interfered with subject treatment, assessment or compliance with the protocol
- Excessive alcohol ingestion or significant drug abuse
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/06/2012
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
1/05/2013
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Sample size
Target
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Accrual to date
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Final
202
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Recruitment in Australia
Recruitment state(s)
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Recruitment outside Australia
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United States of America
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California
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Colorado
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District of Columbia
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Florida
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Georgia
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Auckland
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Christchurch
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Puerto Rico
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San Juan
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Gilead Sciences
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Address
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Ethics approval
Ethics application status
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Summary
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).
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Trial website
https://clinicaltrials.gov/ct2/show/NCT01604850
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Public notes
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Contacts
Principal investigator
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Address
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT01604850
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