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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT01625338
Registration number
NCT01625338
Ethics application status
Date submitted
7/06/2012
Date registered
21/06/2012
Date last updated
9/11/2015
Titles & IDs
Public title
Open-Label Study of Sofusbuvir+Ribavirin With or Without Peginterferon Alfa-2a in Subjects With Chronic HCV Infection Who Participated in Prior Gilead HCV Studies
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Scientific title
An Open-Label Study of GS-7977 + Ribavirin With or Without Peginterferon Alfa-2a in Subjects With Chronic HCV Infection Who Participated in Prior Gilead HCV Studies
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Secondary ID [1]
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0
2012-000571-16
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Secondary ID [2]
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0
GS-US-334-0109
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Chronic Hepatitis C
0
0
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Condition category
Condition code
Infection
0
0
0
0
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Other infectious diseases
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Oral and Gastrointestinal
0
0
0
0
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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 - Peg-IFN
Experimental: SOF+RBV 12 Weeks - SOF+RBV for 12 weeks
Experimental: SOF+RBV 24 Weeks - SOF+RBV for 24 weeks
Experimental: SOF+RBV+Peg-IFN 12 Weeks - SOF+RBV+Peg-IFN for 12 weeks
Treatment: Drugs: SOF
SOF 400 mg tablet administered orally once daily
Treatment: Drugs: RBV
RBV tablets administered orally in a divided daily dose according to package insert weight-based dosing recommendations (\< 75 kg = 1000 mg and = 75 kg = 1200 mg)
Treatment: Drugs: Peg-IFN
Peg-IFN 180 µg administered once weekly by subcutaneous injection
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Intervention code [1]
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0
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 With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (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) at 12 weeks after stopping study treatment.
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Timepoint [1]
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Posttreatment Week 12
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Primary outcome [2]
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Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event
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Assessment method [2]
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Timepoint [2]
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Up to 24 weeks
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Secondary outcome [1]
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Percentage of Participants With SVR at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)
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Assessment method [1]
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SVR4 and SVR 24 were defined as HCV RNA \< LLOQ at 4 and 24 weeks after stopping study treatment, respectively.
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Timepoint [1]
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Posttreatment Weeks 4 and 24
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Secondary outcome [2]
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Percentage of Participants With On-treatment Virologic Failure
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Assessment method [2]
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On-treatment virologic failure was defined as
* Breakthrough (confirmed HCV RNA = LLOQ after having previously had HCV RNA \< LLOQ while on treatment), or
* Rebound (confirmed \> 1 log10 IU/mL increase in HCV RNA from nadir while on treatment), or
* Non-response (HCV RNA persistently = LLOQ through 8 weeks of treatment)
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Timepoint [2]
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Up to 24 weeks
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Secondary outcome [3]
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Percentage of Participants With Viral Relapse
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Assessment method [3]
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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.
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Timepoint [3]
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Up to Posttreatment Week 24
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Eligibility
Key inclusion criteria
* Infection with HCV
* Must have participated in a prior Gilead HCV study
* Use of highly effective contraception methods if female of childbearing potential or sexually active male
* Eligible patients include those in the following
* received placebo or Peg-IFN+RBV in a control arm
* previously participated in a Gilead-sponsored HCV study and did not attain sustained virologic response 24 weeks after discontinuation of therapy (SVR24) on a regimen containing:
* Sofosbuvir+RBV
* Peg-IFN and/or RBV in combination with one or more Gilead investigational direct-acting agents
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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
* Pregnant or nursing female or male with pregnant female partner
* Current or prior history of clinical hepatic decompensation
* Infection with hepatitis B virus (HBV) or human immunodeficiency virus (HIV)
* Chronic use of systemically administered immunosuppressive agents
* Active drug abuse
* Use of any prohibited concomitant medications
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Non-randomised 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
Open (masking not used)
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Who is / are masked / blinded?
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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
1/12/2014
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Sample size
Target
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Accrual to date
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Final
534
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Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC,WA
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Recruitment hospital [1]
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Concord Repatriation General Hospital - Concord
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Westmead Hospital - Westmead
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Gallipoli Medical Research Foundation - Greenslopes
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Royal Adelaide Hospital - Adelaide
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Austin Hospital - Heidelberg
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Monash Medical Centre - Melbourne
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B2 Clinic - Fremantle
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Canberra Hospital - Australian Capital Territory
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St. Vincent's Hospital - Fitzroy
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Royal Brisbane & Women's Hospital - Herston
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St George Hospital - Kogarah
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Royal Prince Alfred Hospital, Camperdown - NSW
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Royal Perth Hospital - Perth Western Australia
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Princess Alexandra Hospital - State of Queensland
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Box Hill Hospital - Victoria
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Recruitment postcode(s) [1]
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2139 - Concord
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2145 - Westmead
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4120 - Greenslopes
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5000 - Adelaide
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3084 - Heidelberg
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3168 - Melbourne
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6160 - Fremantle
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2605 - Australian Capital Territory
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3065 - Fitzroy
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QLD 4029 - Herston
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2217 - Kogarah
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2050 - NSW
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6000 - Perth Western Australia
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4102 - State of Queensland
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Recruitment postcode(s) [15]
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3128 - Victoria
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Nottingham
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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 will evaluate the efficacy, safety, and tolerability of sofosbuvir (SOF; GS-7977) in combination with ribavirin (RBV) with or without pegylated interferon (Peg-IFN) in adults with chronic hepatitis C virus (HCV) infection who participated in a prior Gilead HCV study and have not achieved sustained virologic response (SVR).
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Trial website
https://clinicaltrials.gov/study/NCT01625338
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Bittoo Kanwar, MD
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Address
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Gilead Sciences
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Contact person for scientific queries
No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results are available at
https://clinicaltrials.gov/study/NCT01625338
Download to PDF