SOF (Sovaldi®) +RBV for 16 or 24 Weeks and SOF+RBV+Peg-IFN for 12 Weeks in Adults With Genotype 2 or 3 Chronic HCV Infection
NCT ID: NCT01962441
Last Updated: 2017-06-20
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
601 participants
INTERVENTIONAL
2013-09-24
2016-07-07
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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SOF+RBV 16 weeks
SOF+RBV for 16 weeks
SOF
400 mg tablet administered orally once daily
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)
SOF+RBV 24 weeks
SOF+RBV for 24 weeks
SOF
400 mg tablet administered orally once daily
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)
SOF+RBV+Peg-IFN 12 weeks
SOF+RBV+Peg-IFN for 12 weeks
SOF
400 mg tablet administered orally once daily
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)
Peg-IFN
180 µg administered via subcutaneous injection once weekly
Retreatment Substudy
Participants from the SOF+RBV arms (16 weeks or 24 weeks) who experienced virologic failure on treatment, or during the posttreatment period at or before Posttreatment Week 24 may be eligible to enroll into the Retreatment Substudy to receive SOF+RBV+Peg-IFN for 12 weeks.
SOF
400 mg tablet administered orally once daily
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)
Peg-IFN
180 µg administered via subcutaneous injection once weekly
Interventions
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SOF
400 mg tablet administered orally once daily
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)
Peg-IFN
180 µg administered via subcutaneous injection once weekly
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Confirmed chronic HCV infection.
* Subjects will have cirrhosis status assessment; liver biopsy may be required.
* Genotype 2 subjects must have cirrhosis of the liver to be eligible.
* Treatment-naive or prior treatment failure to ≥12 weeks of an interferon- based regimen that was not discontinued prematurely due to an adverse event
* Infection with HCV genotype 2 or 3 as determined at Screening
* Body mass index (BMI) greater than or equal to 18 kg/m\^2
* Screening laboratory values within predefined thresholds.
* Liver imaging (e.g., ultrasound) within 6 months of Baseline/Day 1 is required in cirrhotic patients to exclude hepatocellular carcinoma (HCC). In the event of intrahepatic lesions, triple phase CT scan or MRI should be performed to exclude HCC.
* Subject must be of generally good health as determined by the Investigator.
Exclusion Criteria
* Pregnant or nursing female or male with pregnant female partner
* History of any other clinically significant chronic liver disease.
* HIV or chronic hepatitis B virus (HBV) infection.
* Malignancy with the exception of certain resolved skin cancers.
* Chronic use of systemically administered immunosuppressive agents.
* Clinically-relevant drug or alcohol abuse.
* History of solid organ transplantation.
* Current or prior history of clinical hepatic decompensation.
* History of clinically-significant illness or any other major medical disorder that may interfere with subject treatment, assessment or compliance with the protocol.
* Known hypersensitivity to interferon, RBV, the study investigational medicinal product, the metabolites, or formulation excipients.
18 Years
ALL
No
Sponsors
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Gilead Sciences
INDUSTRY
Responsible Party
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Principal Investigators
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Gilead Study Director
Role: STUDY_DIRECTOR
Gilead Sciences
Locations
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Riverside, California, United States
San Diego, California, United States
San Francisco, California, United States
Aurora, Colorado, United States
Englewood, Colorado, United States
Miami, Florida, United States
Wellington, Florida, United States
Marietta, Georgia, United States
New Orleans, Louisiana, United States
Boston, Massachusetts, United States
Novi, Michigan, United States
Saint Paul, Minnesota, United States
Hillsborough, New Jersey, United States
Newark, New Jersey, United States
Binghamton, New York, United States
New York, New York, United States
Germantown, Tennessee, United States
Nashville, Tennessee, United States
Nashville, Tennessee, United States
Arlington, Texas, United States
Austin, Texas, United States
Norfolk, Virginia, United States
Seattle, Washington, United States
Camperdown, New South Wales, Australia
Kogarah, New South Wales, Australia
Westmead, New South Wales, Australia
Brisbane, Queensland, Australia
Greenslopes, Queensland, Australia
Woolloongabba, Queensland, Australia
Adelaide, South Australia, Australia
Clayton, Victoria, Australia
Fitzroy, Victoria, Australia
Heidelberg, Victoria, Australia
Melbourne, Victoria, Australia
Nedlands Perth, Western Australia, Australia
Calgary, Alberta, Canada
Edmonton, Alberta, Canada
Vancouver, British Columbia, Canada
Vancouver, British Columbia, Canada
Vancouver, British Columbia, Canada
Winnipeg, Manitoba, Canada
Hamilton, Ontario, Canada
London, Ontario, Canada
Ottawa, Ontario, Canada
Toronto, Ontario, Canada
Toronto, Ontario, Canada
Montreal, Quebec, Canada
Québec, Quebec, Canada
Grafton, Auckland, New Zealand
Grafton, Auckland, New Zealand
Christchurch, Chatham Islands, New Zealand
Hamilton, Waikato Region, New Zealand
Wellington, , New Zealand
Edgbaston, Birmingham, United Kingdom
Cambridge, Cambridgeshire, United Kingdom
London, LN, United Kingdom
London, LN, United Kingdom
London, LN, United Kingdom
London, LN, United Kingdom
Birmingham, , United Kingdom
Bradford, , United Kingdom
Dundee, , United Kingdom
Edinburgh, , United Kingdom
Edinburgh, , United Kingdom
Frimley, , United Kingdom
Glasgow, , United Kingdom
Glasgow, , United Kingdom
Leeds, , United Kingdom
Liverpool, , United Kingdom
London, , United Kingdom
London, , United Kingdom
Manchester, , United Kingdom
Newcastle upon Tyne, , United Kingdom
Nottingham, , United Kingdom
Oxford, , United Kingdom
Plymouth, , United Kingdom
Portsmouth, , United Kingdom
Southampton, , United Kingdom
Countries
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References
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Foster GR, Pianko S, Brown A, Forton D, Nahass RG, George J, Barnes E, Brainard DM, Massetto B, Lin M, Han B, McHutchison JG, Subramanian GM, Cooper C, Agarwal K; BOSON Study Group. Efficacy of sofosbuvir plus ribavirin with or without peginterferon-alfa in patients with hepatitis C virus genotype 3 infection and treatment-experienced patients with cirrhosis and hepatitis C virus genotype 2 infection. Gastroenterology. 2015 Nov;149(6):1462-70. doi: 10.1053/j.gastro.2015.07.043. Epub 2015 Aug 4.
Other Identifiers
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2013-002641-11
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
GS-US-334-0153
Identifier Type: -
Identifier Source: org_study_id
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