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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT01687270
Registration number
NCT01687270
Ethics application status
Date submitted
12/09/2012
Date registered
18/09/2012
Date last updated
19/12/2014
Titles & IDs
Public title
Safety and Efficacy of Sofosbuvir and Ribavirin in Adults With Recurrent Chronic Hepatitis C Virus (HCV) Post Liver Transplant
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Scientific title
A Phase 2, Multicenter, Open-Label Study to Investigate the Safety and Efficacy of GS-7977 and Ribavirin for 24 Weeks in Subjects With Recurrent Chronic HCV Post Liver Transplant
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Secondary ID [1]
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2012-002417-19
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Secondary ID [2]
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GS-US-334-0126
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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:
Recurrent Chronic Hepatitis C Virus
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Post Liver Transplant
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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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Other
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Research that is not of generic health relevance and not applicable to specific health categories listed above
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Intervention/exposure
Study type
Interventional(has expanded access)
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Description of intervention(s) / exposure
Treatment: Drugs - Sofosbuvir
Treatment: Drugs - RBV
Experimental: SOF+RBV - Participants will receive sofosbuvir+RBV for 24 weeks.
Treatment: Drugs: Sofosbuvir
Sofosbuvir 400 mg tablet administered orally once daily
Treatment: Drugs: RBV
Ribavirin (RBV) 200-mg tablet(s) administered orally in a divided daily dose starting at 400 mg, subsequently adjusted (range: 200 to 1200 mg in a divided daily dose) based upon a number of factors including hemoglobin value, creatinine clearance, and weight.
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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 With Sustained Virologic Response 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) 12 weeks following the last dose of study drug.
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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 Discontinue Study Drug Due to an Adverse Event
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Assessment method [2]
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Timepoint [2]
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Baseline to Week 24
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Secondary outcome [1]
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Percentage of Participants With Sustained Virologic Response (SVR) at 4, 24, and 48 Weeks After Discontinuation of Therapy (SVR4, SVR24, and SVR48)
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Assessment method [1]
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SVR4, SVR 24, and SVR 48 were defined as HCV RNA \< LLOQ 4, 24, and 48 weeks following the last dose of study drug, respectively.
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Timepoint [1]
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Posttreatment Weeks 4, 24, and 48
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Secondary outcome [2]
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Percentage of Participants With HCV RNA < LLOQ at Weeks 12 and 24
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Assessment method [2]
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Timepoint [2]
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Weeks 12 and 24
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Secondary outcome [3]
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HCV RNA and Change From Baseline at Weeks 2, 4, and 8
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Assessment method [3]
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Timepoint [3]
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Baseline; Weeks 2, 4, and 8
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Secondary outcome [4]
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Percentage of Participants With Virologic Failure
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Assessment method [4]
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Virologic failure was defined as on-treatment virologic failure or virologic relapse.
* On-treatment virologic failure: HCV RNA \< LLOQ during treatment with subsequent detectable HCV RNA while continuing treatment
* Virologic relapse: HCV RNA \< LLOQ at last observed on-treatment HCV RNA measurement and HCV RNA = LLOQ after stopping treatment (2 consecutive HCV RNA measurements or last available HCV RNA measurement)
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Timepoint [4]
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Up to Posttreatment Week 24
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Eligibility
Key inclusion criteria
* Subjects with evidence of chronic HCV (all genotypes) documented pretransplantation
* HCV RNA = 10,000 IU/mL at screening
* Absence of organ rejection as documented by post transplant liver biopsy taken no more than 12 months prior to baseline/Day 1 visit
* Liver transplant = 6 months and = 12 years prior to screening
* Naive to all nucleotide/nucleoside treatments for chronic HCV infection
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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
* Multiorgan transplant that includes heart or lung recipient
* Subjects with de novo or recurrent Hepatocellular Carcinoma(HCC) post transplant
* Current use of corticosteroids at any dose > 5mg of prednisone/day (or equivalent dose of corticosteroid)
* Infection with hepatitis B virus (HBV) or HIV at screening
* Current, uncontrolled ascites, variceal hemorrhage, hepatic encephalopathy, hepatorenal syndrome, hepatopulmonary syndrome, or other signs of decompensated cirrhosis
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Study design
Purpose of the study
Treatment
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Allocation to intervention
NA
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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
Single group
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Other design features
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Phase
Phase 2
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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
1/11/2012
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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
1/08/2014
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Sample size
Target
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Accrual to date
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Final
40
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Recruitment in Australia
Recruitment state(s)
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Recruitment outside Australia
Country [1]
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United States of America
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State/province [1]
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California
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United States of America
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State/province [2]
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Indiana
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Country [3]
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United States of America
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Kansas
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Country [4]
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United States of America
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State/province [4]
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Massachusetts
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Country [5]
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United States of America
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State/province [5]
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Michigan
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Country [6]
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United States of America
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State/province [6]
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Minnesota
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Country [7]
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United States of America
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State/province [7]
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New York
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Country [8]
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France
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State/province [8]
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Villejuif
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Country [9]
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Germany
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State/province [9]
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Lower Saxony
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Country [10]
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New Zealand
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State/province [10]
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Auckland
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Country [11]
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Spain
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State/province [11]
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Barcelona
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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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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
This is an open-label, single-arm study of sofosbuvir (GS-7977) and ribavirin (RBV) in adults who have had a liver transplant which has become re-infected with hepatitis C. The treatment period is 24 weeks with up to 48 weeks of follow up. The total time in this study will last up to 72 weeks not including the screening visit.
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Trial website
https://clinicaltrials.gov/study/NCT01687270
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Trial related presentations / publications
Charlton M, Gane E, Manns MP, Brown RS Jr, Curry MP, Kwo PY, Fontana RJ, Gilroy R, Teperman L, Muir AJ, McHutchison JG, Symonds WT, Brainard D, Kirby B, Dvory-Sobol H, Denning J, Arterburn S, Samuel D, Forns X, Terrault NA. Sofosbuvir and ribavirin for treatment of compensated recurrent hepatitis C virus infection after liver transplantation. Gastroenterology. 2015 Jan;148(1):108-17. doi: 10.1053/j.gastro.2014.10.001. Epub 2014 Oct 7.
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Public notes
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Contacts
Principal investigator
Name
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Jill M. Denning, MA
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Address
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Gilead Sciences
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Phone
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Fax
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Email
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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
Type
Citations or Other Details
Journal
Charlton M, Gane E, Manns MP, Brown RS Jr, Curry M...
[
More Details
]
Results are available at
https://clinicaltrials.gov/study/NCT01687270
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